Home

TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON

1. Chair toilet Commode fixed mobile adjustable A chair designed with a toilet like seat that allows an immobilized person patient to utilize a standard stationary toilet without leaving the chair Chair MRI system A chair or stool specifically designed to support and position a patient during examinations involving the use of a diagnostic magnetic resonance imaging MRI system For MRI system compatibility these chairs stools are made of ferro magnetically inactive materials Chart Chart dental colour discrimination Shade guide dental A device used to determine the correct shade colour of filling materials artificial crowns and teeth for matching to those of the patient Chart eye Amsler grid A ophthalmic device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field Chart eye colour discrimination An ophthalmic chart with coloured figures printed on coloured 52 Keyword Device identifier Description Intended Use Colour blindness test chart Colour discrimination chart backgrounds used in testing colour vision Chart visual acuity Vision test chart Visual acuity chart An ophthalmic chart imprinted with block letters or other symbols in gradually decreasing sizes identified a
2. Device identifier Description Intended Use Magnifier operating Spectacle operating loupe ophthalmic vision Mask Mask resuscitation Mask mouth to mask Resuscitation CPR Mask Pocket Mask A malleable cone placed over the nose and mouth to administer air to a patient during cardiopulmonary resuscitation CPR The device is designed to replace mouth to mouth resuscitation therefore avoiding cross contamination The device may include an airway one way valve or other component Mask surgical A device made from fabric or other material placed over the nose and mouth by medical personnel to prevent the transmission of airborne organisms while surgery is being performed This device is disposable Mirror Mirror ENT Hand held An instrument with a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it for purpose of ear nose throat ENT examinations This mirror is mounted on a long slender handle and is held by the doctor who can manipulate the mirror close to the site of interest This is a reusable device Mirror ENT headband An instrument with a circular concave mirror attached to a headband acting as a reflector that is used to project a beam of deflected light to a body cavity e g the nose or larynx for purposes of ear nose throat ENT examinations The doctor will wear this devi
3. Guidelines on Submission of Documentation for Registration of Medical Devices Page 26 of 72 O Certified copy of business registration certificate with business registration number is enclosed C2 L Certified copy of Power of attorney or formal agreement or any other official authorization of the LRP is enclosed C3 The LRP is also an importer of the device named in Part D Part D Particulars of the Device D1 Generic name of the Device D2 Brand name of the device D3 Model Series System if applicable D4 Family if applicable D5 Country of origin Select GMDN Global Medical Device Nomenclature Categories D6 O1 Active implantable device 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro mechanical devices O5 Hospital hardware 06 In vitro diagnostic devices O7 Non active implantable devices 08 Ophthalmic and optical devices 09 Reusable instruments 10 Single use devices 11 Technical aids for disabled persons 12 Diagnostic and therapeutic radiation devices 13 Complimentary therapy devices 14 Biologically derived devices Guidelines on Submission of Documentation for Registration of Medical Devices Page 27 of 72 15 Healthcare facility products and adaptations 16 Laboratory equipment 17 Others D7 Description of the device Please enter appropriate GMDN description If none of the de
4. Brush Brush cleaning surgical A device used by hospital staff for scrub the purpose of scrubbing the hands fingers and forearms prior to Brush scrub operating surgery or other intervention where room a high degree of personal hygiene is required It typically consists of a Brush surgical scrub flat handle or a block with side grips on one side and bristles Scrub brush surgical fibers or spines are typically mounted along a single plane Chair Chair bath shower A device designed to be sat upon by a using some washing facility where there is a need to sit The sitting requirement can be e g because the person is disabled or infirm or because it is part of medical treatment Chair blood donor A device used to position the patient in such a manner that a technician nurse has easy access to the patient s arm for drawing 51 Keyword Device identifier Description Intended Use blood The arm board that is attached to the chair has lateral and height adjustments so that the patient s arm can be positioned in a location that is easily accessible to whoever is drawing the blood sample This chair can typically be tilted moved so that the donor lies in a reclining position Chair examination treatment A device used to position the patient in a sitting semi sitting or reclined posture for easy access and patient comfort during an examination treatment or surgical intervention
5. IV infusion pulling out a catheter or interfering with wound care This is a single use device Immobiliser knee A rigid support used to temporarily render the knee immovable strait jacket effect either pre operatively or following injury or arthroscopy Immobiliser shoulder reusable A non rigid device used to temporarily immobilize or limit abduction of the shoulder joint strait jacket effect to support healing of an injury or a surgical wound It is typically used 56 Keyword Device identifier Description Intended Use postoperatively and for post traumatic treatment of injuries in the shoulder and upper arm areas e g distortion contusion dislocation luxation and postoperative support It will typically consist of layered fabric straps buckles fasteners and will eliminate most of the work involved with bandaging Immobiliser whole body A non rigid device usually made of a fabric and or plastic materials used to temporarily render the patient s whole body immovable strait jacket effect while the patient undergoes therapeutic or diagnostic interventions This is a reusable device Immobiliser wrist Wrist restrainer A rigid support designed to temporarily render the wrist immovable strait jacket effect as therapy for non displaced fractures strains sprains and muscle injuries of the wrist It comes in a variety of sizes and is a reusable
6. Software Verification and Validation if applicable Provide information on the software design and development process and evidence of the validation of the software as used in the finished device This information should typically include the summary results of all verification validation protocol and report and testing performed both in house and in a simulated or actual user environment prior to final release It should also address all of the different hardware configurations and where applicable operating systems identified in the labelling Devices Containing Biological Material if applicable Provide results of studies substantiating the adequacy of the measures taken with regards to the risks associated with transmissible agents This will include viral clearance results for known hazards Donor screening concerns must be fully addressed and methods of harvesting must also be fully described Process validation results are required to substantiate that manufacturing procedures are in place to minimize biological risks Pre clinical Studies if applicable Provide detailed information on pre clinical animal studies conducted to justify the probability of effectiveness in humans These studies must follow Good Laboratory Practices The objective methodology results analysis and manufacture s conclusions must be presented The study conclusion should address the device s interactions with animal fluids and tissues and t
7. by providing a means of support and increasing their ability to move around without attendance from another person It is a non wheeled frame with built in handgrips and legs which provide support whilst 69 Keyword Device identifier Description Intended Use walking It can be of fixed or Walker mechanical adjustable height and collapsible or non collapsible Walker standard Walker chair non wheeled Walking chair Walker side Walking frame rigid adjustable Walking frame folding adjustable Walking table A mobility aid used to assist a disabled or infirm user in walking by providing a means of support and increasing their ability to move around without attendance from another person It is a chest height wheeled frame with a horizontal forearm support which is pushed along using the arms and or upper body It can be of fixed or adjustable height and collapsible and non collapsible Walking frame wheeled A mobility aid used to assist a disabled or infirm user in walking Walker wheeled by providing a means of support and increasing their ability to move Walker chair Wheeled around without attendance from another person It is a wheeled Walking frame with frame with built in handgrips and wheels pushed forward legs which provide support whilst by the hands walking It can be of fixed or adjustable height and collapsible or non collapsible Walking Walking Stick A mobility
8. manufactured in such a way as to ensure that where practicable the quantity geometry and quality of radiation emitted can be varied amp controlled taking account of the intended uses 38 11 5 2 Devices emitting ionising radiation intended for diagnostic radiology shall be designed amp manufactured in such a way as to achieve appropriate image and or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user 11 5 3 Devices emitting ionising radiation intended for therapeutic radiology shall be designed amp manufactured in such a way as to enable reliable monitoring amp control of the delivered dose the beam type amp energy amp where appropriate the quality of the radiation 12 WZ I Requirements for medical devices connected to or equipped with an energy source Devices incorporating electronic programmable systems must be designed to ensure the repeatability amp performance of these systems according to their intended use In the event of a single fault condition in the system appropriate means should be adopted to eliminate or reduce as far as possible consequent risks 12 2 Devices where safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply 12 3 Devices where the safety of the patient depends on an external power supply m
9. 41 12 9 The function of the controls amp indicators must be clearly specified on the devices Where a device bears instructions required for its operation or indicates operation or adjustment parameters by means of a visual system such information must be understandable to the user amp as appropriate the patient 13 13 1 Information supplied by the manufacturer Users should be provided with the information needed to identify the manufacturer to use the device safely and to ensure the intended performance taking account of their training and knowledge This information should be easily understood 14 Performance evaluation including where appropriate clinical evaluation l r I All data generated in support of performance evaluation should be obtained in accordance with the relevant requirements applicable 14 2 Clinical investigation on human subjects should be carried out in accordance with the spirit of the Helsinki Declaration This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results In addition some countries may have specific regulatory requirements for pre study protocol review or informed consent 42 I declare that the information provided in this form is accurate and correct and the device conforms to all applicable requirements stipulated a
10. Screening Fees per dossier US 50 ii Evaluation Fees per dossier Risk Class Fees Class B US 500 Class C US 750 Class D US 1000 Screening fees is payable at the time of lodging an application and evaluation fee is payable once an application has been accepted for evaluation The fees may be paid directly to TFDA or by bank transfer to Tanzania Food and Drugs Authority Account No 100380013 USD Citibank Tanzania Ltd Dar es Salaam Head office Peugeot House 36 Upanga Road P O Box 71625 Dar es Salaam Tanzania Swift Code CITITZTZ Local currency Account No 6503900110 National Microfinance Bank Kariakoo Branch OR by banker s draft Guidelines on Submission of Documentation for Registration of Medical Devices Page 13 of 72 When payment is made by bank transfer all bank charges shall be borne by the applicant who shall also make sure that advice note is submitted to TFDA giving details of the payment in particular the name of the applicant the device or devices paid for and amount of fees paid Both screening and evaluation fees are non refundable once paid to the Authority For each registered device an annual retention fees shall be paid on or before the end of January of each year for which the fees are due to mantain a medical device on the medical device register The registration number of the device must be quoted at the time of payment Risk Class Annual Re
11. a hydraulic Bed hydraulic adjustable mechanism to adjust the height and hospital surface contour of the bed This device may include moveable and latch able side rails Bed general purpose A bed designed to be used as a electrically powered general purpose patient bed in e g hospital wards and which is Bed AC powered electrically powered motorized adjustable hospital providing the patient nursing staff with touch button adjustment possibilities Bedpan Bedpan fracture A device used by a_ bedridden patient as receptacle for urine and faeces and which is designed to be used by a patient whose hips have 49 Keyword Device identifier Description Intended Use been plastered This device is reusable after the appropriate cleaning procedure has been done Bedpan general purpose A device used by a bedridden patient as receptacle for urine and faeces This device is reusable after the appropriate cleansing procedure has been done Binder Abdominal binder A strip or roll of fabric or plastic material applied to the abdomen to support relaxed abdominal walls Ankle binder A strip or roll of fabric or plastic material designed to support the ankle joint Breast binder A strip or roll of fabric or plastic material designed to support the breasts Chest binder A strip or roll of fabric or plastic material designed to support the ribs and chest Binder s
12. accessory which is a recognized in the Official National Formulary or Pharmacopoeia or any supplement to them b intended for use in the diagnosis of disease or other conditions or in the cure mitigation treatment or prevention of disease in man or other animals or c intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within the body of man or other animals and which is not dependent upon being metabolised for the achievement of any of its principle intended purposes Medical Device Family A group of medical devices that are made by the same manufacturer that differ only in shape colour flavour or size that have the same design and manufacturing process and that have the same intended use Medical Device Group Medical device comprising a collection of medical devices such as a procedure pack or tray that is sold under a single name Medical Device System A medical device comprising a number of components or parts intented to be used together to fullfill some or all of the device s intended functions and that is sold under a single name The term person includes legal entities such as a corporation a partnership or an association Guidelines on Submission of Documentation for Registration of Medical Devices Page 8 of 72 National Standard A standard as prescribed by the Tanzani
13. ankle immovable strait jacket effect to support the healing of an injury or surgical wound Immobiliser arm A non rigid device usually made of a fabric used to temporarily render the arm immovable strait jacket effect typically at the shoulder and elbow to support the healing of an 55 Keyword Device identifier Description Intended Use injury or surgical wound Immobiliser elbow A non rigid device usually made of a fabric used to temporarily render the elbow immovable strait jacket effect to support healing of an injury or a surgical wound Immobiliser infant reusable A non rigid device usually made of a fabric and or plastic materials used to temporarily render parts of an infant s body immovable strait jacket effect e g the arms and or feet while the patient undergoes therapeutic or diagnostic interventions It will typically be used to prevent the patient from interrupting an intravenous IV infusion pulling out a catheter or interfering with wound care This is a reusable device Immobiliser infant single use A non rigid device usually made of a fabric and or plastic materials used to temporarily render parts of an infant s body immovable strait jacket effect e g the arms and or feet while the patient undergoes therapeutic or diagnostic interventions It will typically be used to prevent the patient from interrupting an intravenous
14. applicable other persons provided associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health amp safety The solutions adopted by the manufacturer for the design amp construction of the devices must conform to safety principles taking account of the generally acknowledged state of the art In selecting the most appropriate solutions the manufacturer must apply the following principles in the following order eliminate or reduce risks as far as possible inherently 31 safe design amp construction where appropriate take adequate protection measures including alarms if necessary in related to risks that cannot be eliminated inform users of the residual risks due to any shortcomings of the protection methods adopted The devices must achieve the performance intended by the manufacturer and be designed manufactured amp packaged in such a way that they are suitable for one or more of the functions referred to as specified by the manufacturer The characteristics amp performances referred to in sections 1 2 amp 3 must not be adversely affected to such a degree that the clinical condition amp safety of the patients amp where applicable of other persons are compromised during the lifetime of the device as indicated by the manufacturer when the device is subjected to the
15. by a fixed pedestal or a movable swivel caster base Most tables are divided into three or more hinged sections e g head body and legs and are raised and lowered by hydraulic systems using manual or electric controls Table birthing Birthing table Table obstetrical An adjustable table designed to support a woman s body in an appropriate position during labour and delivery and in other examination treatment procedures related to pregnancy This table will typically include receptacle for afterbirth Traction unit non active Traction unit no active Apparatus traction non powered Unit traction hip non powered non penetrating Extension and traction equipment Static traction unit Traction unit static bed Traction unit static chair A device used to apply a tensile force in order to create a distraction on body parts by means of harnesses attached the head or pelvic area It is non active static in operation It consists of a rigid frame with non powered traction accessories such as cords pulleys or weights and that is intended to apply a therapeutic pulling force to the skeletal system Traction unit Traction unit noninvasive component A noninvasive traction device e g a head halter pelvic belt or a traction 68 Keyword Device identifier Description Intended Use noninvasive splint that does not penetrate the component Fram
16. designed for applying dry cold therapy to an external area of the body Ice is placed into a container that usually has flexible 47 Keyword Device identifier Description Intended Use walls The device may include a holder that keeps the bag in place Bandage Bandage self adherent A flexible piece strip or roll of fabric or plastic material that is applied to typically wrapped around a part of the body to secure a dressing maintain pressure over a compress or immobilize a limb or other body part This is usually a single use device Bandage clavicle A strip or roll of fabric or webbed material that is wrapped around the shoulder girdle to maintain fixation and longitudinal extension of the clavicle during a period of treatment This is a single use device Bandage elastic An elasticized fabric e g polyamide lycra used to provide support or local pressure to a part of the body especially a joint while allowing movement It may have various configurations e g long flat strip tubular to accommodate various body parts e g ankles knees wrists neck This is a reusable device Bandage gauze Cotton gauze swabs A piece or strip of fabric made of opened weave cotton or rayon fibers and of differing degrees of fineness used to cover and protect wounds This is a single use device Bandage gauze roller Cotton gauze dressing Dressing roller gauze A long
17. device Incontinence Incontinence pants liner Urine absorbing aid body worn Adult diapers Incontinence diapers A disposable inner incontinence pants liner composed of absorbent materials used to collect urine and faeces from the patient Lens Lens Set trial Trial lens set ophthalmic A set of ophthalmic lenses of various dioptric powers intended to be handled or inserted in a trial frame for vision testing to determine the required refraction Light Light head worn Headlamp operating A device a lamp designed to be worn on an operator s head It is mounted on a band or helmet frame 57 Keyword Device identifier Description Intended Use Headlight Headlight fiberoptic focusing Light headband surgical Light surgical headlight and situated on the user s forehead providing a light direct into the field of vision during surgical diagnostic or therapeutic procedures The light typically consists of a magnifying lens a reflector and a connection for the fiberoptic cable to transfer cold light or power supply from a battery pack Light surgical Lamp operating room Lamp surgical Lamp surgical incandescent Light surgical ceiling mounted Light surgical connector Light surgical floor standing Light surgical instrument Operating room light Operating shadowless light OR light Surgical lamp A device tha
18. device typically consists of a compact envelope made of plastic which is filled with special chemicals that are reactive when activated Compress cold pack Cold compress Cold pack A device that is intended to be applied with pressure to a body surface and or underlying tissue e g muscle This device typically consists of a compact fabric envelope containing a hydrated pliable silicate gel capable of forming to the contour of the body Compress hot cold pack Hot cold pack A device that is intended to be applied with pressure to a body surface to provide cold or heat therapy to that surface and or underlying tissue e g the muscle This device typically consists of a compact envelope containing a hydrated pliable silicate gel capable of forming to the contour of the body that can be heated or cooled Ice collar compress A flexible device that is intended to be applied around the body surface of the neck and throat to provide cold therapy to the surface and the underlying tissues This will be to alleviate neck and head pain and sore throat e g after tonsillectomy This device will have the appropriate size and shape to fit this part of the anatomy and can be filled with ice the coolant Case Contact lens case A container designed for the storage of contact lenses when the lenses are not being used by the owner Cotton Cotton ball A spherical mass of cotton or man Rayon balls mad
19. devices that match up with the docking devices of the ambulance Stretcher portable Stretcher hand carried Stretcher portable basket 2 fold stretcher A device designed for transporting the patient from an emergency site which is not readily accessible for standard ambulance stretchers This can be e g mountain or marine rescue or difficult indoor situations e g narrow corridors or extremely steep stairways It is 66 Keyword Device identifier Description Intended Use Pole stretcher designed to be lightweight simple in operation and easily transported Scoop stretcher e g ideally by one or two persons The patient is often strapped to the stretcher to keep them secure during vertical or helicopter lifts Swab Swab A piece of absorbent material e g cotton or foam attached to the end Swab cotton of a stick made of wood plastic or wire It is used for the application of Swab specimen collecting medication the removal of material or the collection of bacteria Swab oral care A piece of absorbent material e g cotton or foam attached to the end of a plastic stick that is used for dental hygiene Table Table examination A table or bed for examination treatment Examination bed and or treatment purposes It is typically of the construction where the patient lies upon it ie as an operating table but some may be designed so that the patient sits beside the table
20. performance 40 12 7 3 The devices must be designed amp manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted taking account of technical progress amp of the means available to reduce noise particularly at source unless the emitted is part of the specified performance 12 7 4 The terminals amp connectors to the electricity gas or hydraulic amp pneumatic energy supplies which the user has to handle must be designed amp constructed in such a way as to minimise all possible risks 12 7 5 Accessible parts of devices excluding any parts or areas intended to supply heat or reach given temperatures amp their surroundings must not attain potentially dangerous temperatures under normal use 12 8 12 8 1 Protection against the risks posed to the patient by energy supplies or substances Devices for supplying the patient with energy or substances must be designed amp constructed in such a way that the flow rate can be set amp maintained accurately enough to guarantee the safety of the patient amp the user 12 8 2 Devices must be fitted with the means of preventing and or indicating any inadequacies in the flow rate which could pose a danger Devices must incorporate suitable means to prevent as far as possible the accidental release of dangerous levels of energy from an energy and or substance source
21. purity and sterility of the device or of the materials used in its manufacture c the design of the device including its performance characteristics principles of operation and specifications of materials energy source software or accessories and d the intended use of the device including any new or extend use any addition or deletion of a contraindication for the device and any change to the period used to establish its expiry date These changes will require TFDA approval before they can be implemented Any other change s should be notified immediately to the Authority and may be implemented without prior approval All applications for variation to a registered device shall be made in writing and shall be accompanied by variation fee as prescribed in Fees and Charges Regulations and its Guidelines in force at the time of application 1 10 Applications for renewal of registration Applications for renewal of registration shall be made at least 90 days before the expiry date of registration of the device The application shall include submission of filled in application form annex 1 and information pertaining to changes that were made to a registered device 1 11 Compilation of the dossier Applicants are required to arrange the application dossier for Class B C and D in the format described below a The application form annex I b Device Details item 2 of the guideline Guidelines on Submission of Documentatio
22. the specific hazard alert information that a user needs to know before using the device Precautions State briefly precautions to be taken and any special care necessary for the safe and effective use of the device Adverse Effects Describe all adverse and side effects associated with the device under normal conditions of use Guidelines on Submission of Documentation for Registration of Medical Devices Page 18 of 72 2 10 Alternative Use Describe any alternative practices or procedures for diagnosing treating curing or mitigating the disease or condition for which the device is intended 2 11 Storage conditions State the storage conditions for the device 2 12 Recommended shelf life where applicable State the recommended shelf life of the device Guidelines on Submission of Documentation for Registration of Medical Devices Page 19 of 72 3 SUMMARY TECHNICAL DOCUMENTATION 3 1 Device description and features Provide a detailed description of the device attributes that are necessary to explain how the device functions The details should include a The principle of operation of the device b Description of the key functional elements of the device e g its parts components formulation composition and functionality c Labeled pictorial representation of the device in the form of diagrams photographs or drawings with sufficient explanation should be provided 3 2 Evidence of Conformity to Essential Prin
23. HE DOSSIER cccccccccccccccccccccccccssccccccccccccsceesscsceesccsoees 16 2 DEVICE DETAILS i eidsieencdicieicddeaeiet a ceccteccadeoeseieteestedvateocacnvace sb so EE SEa 18 3 SUMMARY TECHNICAL DOCUMENTATION ccccsccccscccccccscccsccccssccccccscces 20 4 LABELLING REQUIREMENT cccccccccccccccccccccccccccscscccccccccecccscessccsceeees 24 ANNEX EA E E ieicdecsetccctecctccsieccseeecsecedsscdsssactcvssceesdccecscsascecsusceccoase 25 ANNEX I icsiooierenes stese sions rass ot saaneena a E E EE TE a e 31 ANNEX UIDs sicvscceeccciciicctvncivcteccisecnce reteaete deve E E Aa iS wees stows oni So EOE e 44 ANNEX IViv eeen eainnt aesaet aoaie n Easa E aE EEOSE 46 Guidelines on Submission of Documentation for Registration of Medical Devices Page 2 of 72 Abbreviations AHWP CSDT DoC EPSP GHTF GMDN GMP HSA ISO LRP MoHSW MSD PHLB QMS Z STD TFDA TFDCA Asian Harmonization Working Party Common Submission Dossier Template Declaration of Conformity Essential Principles of Safety and Performance Global Harmonization Task Force Global Medical Devices Nomenclature Good Manufacturing Practices Health Science Authority International Organization for Standadization Local Responsible Person Ministry of Health and Social Welfare Medical Store Department Private Health Laboratory Board Quality Management System Summary Technical Documentation Tanzania Food and Drugs Authority T
24. Registration of Medical Devices Page 29 of 72 following i ii iii iv v vi vii An attestation that a device complies with the applicable EPSP has been classified accordingly and has met applicable conformity assessment elements Information sufficient to identify the device including its nomenclature The risk class allocated to the device Which of the conformity assessment elements have been applied The date from which the DoC is valid The name and address of the device manufacturer The name position and signature of the responsible person who has been authorized to complete the DoC Declaration by applicant I the undersigned certify that all the information in this form and accompanying documentation is correct and true to the best of my knowledge Name Position Signature Official stamp Date Guidelines on Submission of Documentation for Registration of Medical Devices Page 30 of 72 Annex II ESSENTIAL REQUIREMENTS CHECK LIST Brand name Common name RISK CLASS Essential Principal Applicable to Method of Identity of the device Conformity specific Documents GENERAL REQUIREMENTS The device must be designed amp manufactured in such a way that when used under the conditions amp for the purposes intended they will not compromise the clinical condition or the safety of patients or the safety amp health of users or where
25. S The devices must be designed amp manufactured in such a way that they can be used safely with the materials substances amp gases with which they enter into contact during normal use or during routine procedures if they are intended to administer medicinal products they must be designed amp manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use 7 4 Where a device incorporates as an integral part a substance which if used separately may be considered 33 to be a medicinal product amp which is liable to act upon the body with action ancillary to that of the device the safety quality amp usefulness of the substance must be verified taking account of the intended purpose of the device by analogy with the appropriate methods T The devices must be designed amp manufactured in such a way as to reduce as much possible risks posed by the unintentional ingress of substances into the device taking into account the device amp the nature of the environment in which it is intended to be used 8 1 Infection amp microbial contamination The devices amp their manufacturing processes must be designed in such a way as to eliminated or reduce as far as is possible the risk of infection to the patient user
26. TFDA Tanzania Food amp Drugs Authority GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES Guidelines on Submission of Documentation for Registration of Medical Devices TABLE OF CONTENT ABBREVIATIONS coos dens seviscecs doce dorate anenee ie SEO Oe e EEEa eres OE 3 ACKNOWLEDGEMENTS 65 siscseecs descdeceseveieess descdecencveieescdeicdvcececsiweds deccdvscdeceveots EPERE 4 FOREWORD isis 5 oisecdesSiee ists iesecdees devesesti OS EEEO S SEERE TEKEE SEERE E SEE ESEESE EES 5 INTRODUCTION corir e Ee EEO EES ESEESE KTE EEE ESEESE EPO EEOSE EER 6 DEFINITION OF TERMS so 0iseees tock eds scene cess doghdele SecaseedcdeesdeenSeedices sdeesdeesscedseesSceesdeexe 7 1 GENERAL REQUIREMENTS cccccscccsscccccccccccccccsccccccccccccscccsscccsscscccessces 10 1 1 APPLICANT 0 isicccosccsiiisiepcdecsseskeccecdsasdesciccdevesdccosdeess sc aeeses sveadeceseees sees coceees 10 1 2 LOCAL RESPONSIBLE PERSON cccccccscsccccccccccccccccccccscccsccscecsccscesscccecescces 10 1 3 FIRST TIME APPLICATION cccccccccccccccccccccccccccccccccccsccccccsceescccccescscecescces 10 1 4 DOCUMENTATION ccccccccccccccccccccccccccccccccccsccescceccesscceeccsceeecssceeecceeeeecces 11 1 4 1 LANGUAGE cccccccccccccccccccccccccscccccceccceeccescccecceeecceeseessseeccesccoeeeee 11 1 4 2 Paper type ANd binding cccceccccccscccccccccscccccccscscccccccccscessees 11 1 5 CLASSIFICATION OF MEDICAL DEVICES cc
27. a Bureau of Standards TBS Objective Evidence Information that can be proved true based on facts obtained through observation measurement testing or other means Performance Evaluation Review of the performance of a medical device based upon data already available scientific literature and where appropriate laboratory animal or clinical investigations Process Validation Confirmation by objective evidence that a process consistently produces a result or product meeting its pre determined requirements Quality System System which consists of the organizational structure responsibilities procedures processes and resources for implementing quality management and achieving the objectives Quality Management System Management system to direct and control an organization with regard to quality from establishing quality policy quality objectives and implementing and maintaining quality system Recall Any action taken by the manufacturer importer or distributor in respect of a medical device that has been sold to recall or correct the device or to notify its owners and users of its defectiveness or potential defectiveness after being aware that the device may be hazardous to health may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness benefits performance characteristics or safety or may not meet the requirements of the Act or regulations Recognised Standards National or I
28. aid used to assist a Stick disabled or infirm user in walking Cane by providing a means of support and increasing their ability to move 70 Keyword Device identifier Description Intended Use Cane adjustable length Cane adjustable length standard handle Cane adjustable length T handle Cane adjustable length Crook handle Walking cane seat Cane fixed length standard handle Cane pedestal base Walking sticks with three or more legs handle and or forearm support Quad cane adjustable height Quad stick adjustable around without attendance from another person It is a wooden or metal rod with either one leg a tripod or quadripod base three or four legs It has a handle and or forearm support It can be of fixed or adjustable length and collapsible or non collapsible 71
29. amp third parties the design must allow easy handling and where necessary minimise contamination of the device by the patient or vice versa during use 8 2 Tissues of animal origin must originate from animals that have been subjected to veterinary controls amp surveillance adapted to the intended use of the tissues Notified Bodies shall retain information on the geographical origin of the animals Processing prevention testing amp handling of tissues cells amp substances of animal origin must be carried out so as to provide optimal security In particular safety with regard to viruses amp other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process 34 8 3 Devices delivered in a sterile state must be designed manufactured and packed in a non reusable pack and or according to appropriate procedures to ensure that they are sterile when placed on the market amp remain sterile under the storage amp transport conditions laid down until the protective packaging is damaged or opened 8 4 Devices delivered in a sterile state must have been manufactured amp sterilised by an appropriate validated method 8 5 Devices intended to be sterilised must be manufactured in appropriately controlled e g environmental conditions 8 6 Packaging systems for non sterile device
30. and is examined with instruments placed upon the table This device can be manually operated or powered It may be fitted with some basic functions e g raise lower or tilt and is used in examination rooms doctors surgeries and minor operating rooms Table instrument Instrument trolley with or without drawers A table used for laying out sterile surgical instruments sutures and other utensils items required during an operation or intervention It is designed to include an appropriate e g stainless steel top or surface with no crevices screws or rivets and most tables include telescoping pedestals for height adjustment and swivel caster bases This table is used in the so called sterile area of the operation site 67 Keyword Device identifier Description Intended Use and in some cases may be attached to the operating table Table Operation Table and attachment operating room Table operating Table operating room Table traction Table operation gynecological Table operation ophthalmic Table operation orthopaedic A device used to support the patients body during surgical procedures stabilizing the patient s position and providing for optimal exposure of the surgical field Operating tables are also designed to protect the patient from excessive manipulation trauma and abrasion It will typically include an appropriate top surface supported
31. anzania Food Drugs and Cosmetic Act of 2003 Guidelines on Submission of Documentation for Registration of Medical Devices Page 3 of 72 Acknowledgements We would like to thank TFDA staff who contributed for successful development of this guideline Acknowledgement is particularly extended to Mr M A Fimbo Mr Y Hebron Mr D Hipolite Mr A Bitegeko Mr A Khea and Ms R Mariki We would also like to thank the Global Harmonization Task Force GHTF World Health Organization WHO Health Canada Asian Harmonization Working Party AHWP and Health Science Authority HSA of Singapore for making their guidelines available for reference Special thanks are also extended to TFDA esteemed stakeholders the dealers in medical devices Medical Store Department MSD Private Health Laboratories Board PHLB Ministry of Health and Social Welfare MoHSW and the academia who discussed the draft guideline and gave commendable inputs for improving the guideline Last but not the least TFDA Management is acknowledged for constructive comments and inputs during deliberation and approval of the guideline Hiiti B Sillo Director Medicines and Cosmetics Tanzania Food and Drugs Authority Guidelines on Submission of Documentation for Registration of Medical Devices Page 4 of 72 Foreword The Tanzania Food and Drugs Authority TFDA was established under the Tanzania Food Drugs and Cosmetics Act 2003 to regulate among other produ
32. bove Name Signature Position Date 43 Annex III THE APPLICATION PROCESS FOR CLASS A MEDICAL DEVICES NOT EXEMPTED FROM REGISTRATION The process described below is applicable solely to Class A medical devices that are not exempted from medical device product registration Registrant identifies medical device to register Registrant submits application Screening of application Review of application Regulatory Decision 1 1 Submission Requirements for Class A Medical Devices Applicants are required to submit the following data for Class A medical devices not exempted from registration along with dully filled in application form as provided in Annex I of this guideline 1 1 1 Copies in English and in original colour of a The labels on the medical device and its packaging are to be provided for the primary and secondary levels of packaging Labels must be provided for all the components of a medical device system members of a medical device family and accessories submitted for registration Alternatively a representative label may be submitted for variants provided the variable fields on the artwork are annotated and the range of values for the variable fields are indicated 44 b The instructions for use where applicable c The patient information leaflet where applicable and d The promotional material including brochures and catalogues 1 1 2 For sterile medical devic
33. ccording to distances at which they are ordinarily visible used in testing visual acuity Such charts are often combined in a box where the individual letters or symbols are selected and highlighted by the optician doctor with back ground electrical lighting Clip Clip nose A device used to help prevent air movement through the nares The device is typically constructed of plastic with rubber or foam tips and is used during pulmonary function studies to help ensure that airflow is conducted through the mouthpiece for accurate measurements Clip spectacle ophthalmic Clip lens trial ophthalmic A device intended to hold prisms spheres cylinders or occluders on a trial frame or set of spectacles during vision testing Clip surgical towel A surgical instrument designed with two sharply pointed blades joined at their midpoint or made out of a single alpha shaped part used to temporarily attach objects together typically during surgery These objects will typically be towels but can be surgical drapes or other devices e g cables leads that need fixation Compress Compress hot cold pack chemical A device that is intended to be applied with pressure to a body surface to provide cold therapy to that surface and or underlying 53 Keyword Device identifier Description Intended Use Heating pad chemical Cooling pad chemical tissue e g muscle This
34. ce on his her head place the reflector in front of one eye and view the site through a small hole in 60 Keyword Device identifier Description Intended Use the centre of the reflector This is a reusable device Mirror dental hand held A dental instrument for intraoral inspection or inspection and retraction generally comprising the mirror head and the mirror handle Mirror general amp plastic surgery A device designed to be used to assist practitioners during general plastic surgery that display a virtual image of an object placed before it Mirror headband ophthalmic An ophthalmic instrument with a circular concave mirror attached to a headband used to project a beam of light to allow examination of the eye and its associated structures Orthosis Orthosis foot ankle AF Ankle foot orthosis Ankle joint orthosis Ankle support Joint ankle external brace An externally applied orthopedic appliance or apparatus used to support align prevent or correct deformities injuries or to improve function of the ankle and or foot Orthosis sacroiliac spine Orthosis sacroiliac soft Sacroiliac orthosis An externally applied orthopaedic appliance or apparatus that encompasses the thoracic spine region of the trunk and is used to support or immobilize deformities fractures sprains or strains of the spine through compression of the abdomen Orthosi
35. cecccccccccccccccccccccccccccccscccccccecescces 11 1 6 REGULATORY CONTROL OF MEDICAL DEVICES ccccccccccccccccccccccccccccccccccescces 12 1 6 1 Medical devices exempted from regisStration cccceccccccccsccscees 12 1 6 2 All other medical AeVICES ccscccseccccccsccccccsccccscsccccscccccssscccssecs 12 1 6 3 Submission requirements for Class A medical devices not exempted TOM TEGiSELALION ccccccccceccccscccccccccsccccencecscenceseeenseeceseesncenceeeeseeseceeeeseess 13 1 7 PAYMENT OF FEES SCREENING AND PROCESSING OF APPLICATIONS ccesseseees 13 1 7 1 Payment Of FECS ccccccccsccccccsccscccccccccccccceccccsccnsescecssesscssesssessees 13 1 7 2 Screening Of application ccsceccccecccccvsccccscccccccsceccccccsscscescees 14 1 7 3 Processing of Applications ccccccccccsccsccccccccecccsccscccccsccecceeces 15 1 8 REGISTRATION OF THE DEVICE cccccccccccccccccccccccccccccccccccsccesccccccscscecescces 15 1 8 1 Validity Of TreGistratio nr cccccccccccccccsccsccccccsccsceccecccssccscescess 15 1 8 2 Termination Of registration cccccccccccccccccscccccccccsccsccccccscescees 15 1 8 3 APPOGlS iesicsccocsccinciictendeadseciesessceudensess icccetescccatesscedeavscsevescevevecesens 15 1 9 APPLICATION FOR VARIATION OF A REGISTERED DEVICE ccccccccccccccccccccceeces 16 1 10 APPLICATIONS FOR RENEWAL OF REGISTRATION cccccccccccccccccccccccccccccecccccees 16 1 11 COMPILATION OF T
36. ciples Provide evidence of conformity to Essential Principles of Safety and Performance EPSP by completing the checklist appended as Annex II Note i Manufacturer should identify the essential principles of safety and performance that are applicable to the device and the general methods used to demonstrate conformity to each applicable Essential Principle The methods that may be used include a Compliance with a recognized or other standard s b Internal industry methods c Comparison to other similar marketed device ii When the manufacturer uses national international or other standards to demonstrate conformity with the Essential Principles full title of the standard identifying numbers date of the standard and the organization that created the standard should be provided Reference e Essential Principles of Safety and Performance of Medical Devices http www ghtf org documents sg1 sg1n41r92005 pdf Guidelines on Submission of Documentation for Registration of Medical Devices Page 20 of 72 3 3 3 4 3 5 3 5 1 Materials Provide description of the materials of the device and their physical properties to the extent necessary to demonstrate conformity with the relevant Essential Principles The information shall include complete chemical biological and physical characterization of the materials of the device Device Specifications Describe functional characteristics and technical performance spec
37. cts the quality safety and performance of medical devices The regulation of medical devices involves amongst other things registration which is an official authorization for the purpose of marketing or free distribution after assessment of safety and performance In order to address various concerns from stakeholers and the general public the Authority has decided to set up a framework for regulating medical devices in Tanzania To begin with the Authority has developed this guideline which defines requirements for registration of medical devices The guideline is first of its kind and together with other requirements it provides guidance on classification of devices depending on their level of risk The Authority will therefore take risk based approach when regulating medical devices The guideline has adapted key elements of the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices STED promulgated by GHTF This is in line with the need for global convergence of regulatory systems of medical devices Applicants are encouraged to familiarize with the guidelines and follow them when preparing and submitting applications for registration of medical devices However the requirements highlighted are minimum and whenever there will be additional information these may be submitted to TFDA Adherence to this guideline will ensure that all relevant information
38. e traction skin and is intended to assist in connecting a patient to a traction Head halter traction apparatus so that a therapeutic pulling force may be applied to the Pelvic traction belt patient s body Tong skull for traction Weights Water bag Transfer Aid Transfer aid person A technical aid used by attending personnel to assist in the physical Board patient transfer transfer of a person patient e g ill disabled or infirm from one Chair patient transfer position to another The device has typically no lifting capabilities and Patient transfer aid uses sliding turning techniques This may be to change the person s Sliding board mat position especially for those incapable of achieving this on their Sheet patient turning own and thus prevent bedsore or to move the person between e g an Turning sheet operating table and a bed a wheelchair and a bath or chair and Turning carpet toilet Walking Walking crutch A mobility aid used to assist a Crutch disabled or infirm user in walking Crutch axillary by providing a means of support and increasing their ability to move Crutch elbow around without attendance from another person It has one leg a Crutch forearm handle and a padded platform which is placed under the armpit or forearm support Walking Walking Frame A mobility aid used to assist a Frame Standard disabled or infirm user in walking Standing frame mobile Walker adjustable width Walker folding
39. e expressed in month and year i unless self evident to the intended user the medical conditions purposes and uses for which the device is manufactured sold or represented including the performance specifications of the device if those specifications are necessary for proper use j the directions for use unless directions are not required for the device to be used safely and effectively and k any special storage conditions applicable to the device In case the device is intended to be sold to the general public labelling information a shall be set out on the outside of the package that contains the device and be visible under normal conditions of sale b where a package that contains a device is too small to display all the information in accordance with a k above the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sell Specimen label s promotional material s and user manual s should be provided Note Requirements that have been described in a respective standard should also be followed when labelling a device Guidelines on Submission of Documentation for Registration of Medical Devices Page 24 of 72 Annex I TANZANIA FOOD AND DRUGS AUTHORITY TFDA Tanzania Food amp Drugs Authority SSS APPLICATION FORM FOR REGISTRATION OF MEDICAL DEVICES Please read this section carefully before completing the fo
40. e fibers used as a swab to apply medications to or remove liquid from various parts of the body 54 Keyword Device identifier Description Intended Use Cotton roll dental A device formed as a small short cotton roll that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures It is usually made of cotton and is disposable Cotton roll general purpose A device usual made of medical cotton or sometimes man made fibers that have a general purpose use throughout hospitals and other areas of the healthcare sector Cover Cover thermometer Thermometer probe cover A device used as a physical barrier for a thermometer to prevent cross contamination between patients and or environmental exposure This device is single use Depressor Depressor tongue Wooden tongue depressors An instrument intended to displace the tongue to facilitate examination of the surrounding organs and tissues Frame Frame spectacle An ophthalmic device worn by the user to hold prescription or protective spectacle lenses in front of their eyes Frame trial ophthalmic A device used in ophthalmic work for placing holding and exchanging trial lenses in front of the eyes of the patient during a sight testing procedure Immobiliser Immobiliser ankle A non rigid device usually made of a fabric used to temporarily render the
41. e provided to enable a person generally familiar with quality systems to judge the appropriateness of the controls in place A brief summary of the sterilization method and processing should be included if any If multiple facilities are involved in the manufacture of device the physical address and overview of activities for each facility should be provided Guidelines on Submission of Documentation for Registration of Medical Devices Page 23 of 72 4 LABELLING REQUIREMENTS Labelling information shall be in English and or Kiswahili and shall be expressed in a legible permanent and prominent manner that can be easily understood by the intended user Depending on the type of device the following minimum information should be provided on the label a the name of the device b the name and address of the manufacturer c the identifier of the device including the identifier of a device that is part of a system test kit medical device group medical device family or medical device group family d batch or lot number e if the contents are not readily apparent an indication of what the package contains expressed in terms appropriate to the device such as size net weight length volume or number of units f the words Sterile if the manufacturer intends to sale the device in a sterile condition g the words for single use only if the device is intended for that puporse h the expiry date of the devic
42. ees and charges regulations b submission of biannual post marketing surveillance reports c submission of adverse effects reports associated with the use of device 1 8 2 Termination of registration The TFDA may by giving reasons in writing suspend or revoke the registration of a device or amend the conditions of its registration The registrant may by giving 60 days written notice and reasons to the TFDA terminate the registration of a device 1 8 3 Appeals Any person aggrieved by a decision of the Authority in relation to any application for registration of a medical device may make representations in writing to TFDA Guidelines on Submission of Documentation for Registration of Medical Devices Page 15 of 72 If after consideration of the representations the Authority is satisfied it may approve registation of a medical device and if not satisfied it shall reject the application In case the applicant is not satisfied with the decision may appeal to the Minister responsible for Health 1 9 Application for variation of a registered device The Authority should be informed on any significant change s that could reasonably be expected to affect the safety or effectiveness of a medical device Significant change s may include any of the following a the manufacturing process facility or equipment b the manufacturing quality control procedures including the methods tests or procedures used to control the quality
43. efined as follows Authority Means the Tanzania Food and Drugs Authority Conformity Assessment The systematic examination of evidence generated and procedures undertaken by the manufacturer under requirements established by the Authority to determine that a medical device is safe and performs as intended by the manufacturer and therefore conforms to the Essential Principles of Safety and Performance of Medical Devices Certified Copy A true copy of the original document certified by a person registered to practice law in the Manufacturer s country of origin and endorsed with the legal practitioner s official stamp and signature Clinical Evaluation The review of relevant scientific literature and or the review and assessment of data collected through clinical investigation Clinical Investigation Any designed and planned systematic study in human subjects undertaken to verify the safety and or performance of a specific device General Medical Device Refer to products falling within the definition of medical devices except in vitro diagnostic medical device In Vitro Diagnostic Medical Device A device whether used alone or in combination intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic monitoring or compatibility purposes This includes reagents calibrators control materials specimen receptacles software and
44. equentially Extension sheets tables diagrams and other supporting documents shall as far as possible be of the same size well annotated numbered and appropriately cross referenced All parts must be bound separately and arranged sequentially in spring file covers with flexible seat Lever arch files are not permissible One or more spring file covers may be used depending on the number of pages contained in a part The file cover should be made of hard non collapsible biodegradable material The thickness should be expandable or reducible depending on the total thickness of the contents 1 5 Classification of general medical devices other than In Vitro Diagnostic IVD medical devices Devices should be classified into one of the four risk classes A B C and D described below CLASS RISK LEVEL DEVICE EXAMPLES A Low Risk Surgical retractors tongue depressors B Low moderate Risk Hypodermic Needles suction equipment Cc Moderate high Lung ventilator bone fixation plate Risk D High Risk Heart valves implantable defibrillator Guidelines on Submission of Documentation for Registration of Medical Devices Page 11 of 72 Classification should be done based on classification rules promulgated by the Global Harmonization Task Force GHTF under the document titled Principle of Medical Devices Classification which can be obtained at http www ghtf org documents sg1 SG N15 2006 classificatio
45. es the sterilization validation report 1 1 3 For medical device with measuring function certification on medical device metrology or equivalent 1 1 4 For active medical devices certification to electrical safety standards e g IEC 60601 1 2 Review of application For class A medical devices not exempted from registration the risk associated with the use of the medical devices has been determined to be low The Authority does not conduct a premarket evaluation of the safety quality and performance for such medical devices The Authority s role in the review of the application is to determine that e The class A medical device is correctly classified i e it is not a class B C or D medical device e The intended purpose indications for use for the class A medical device is appropriate for the design of the medical device i e no exaggerated claims are made In the event that the medical device is incorrectly classified or the product claims are questionable the Authority may request for the full technical documentation of the medical device 45 Annex IV List of Medical Devices Exempted from Product Registration Explanation of listing The listing is tabulated with the following items Item Explanation Keyword An aid to facilitate the search of product in the exempted list Device The name presented in bold that is selected to represent a identifier generic device group Synonym term names pr
46. esented in italic are other names that are commonly used in place of or to identify the device the device identifier Description Provides a description of the medical device that is exempted and its intended purpose Medical devices hat do not meet the description or its intended purpose as provided in the list shall not be exempted from product registration Applicable only if it i fits the given description and ii is solely for the use listed below Keyword Device identifier Description Intended Use Adhesive Adhesive Bandage A piece of a fabric or plastic material not a strip that is applied Bandage dressing to a part of the body with a adhesive pressure sensitive adhesive It may or may not include an absorbent Bandage tape adhesive pad It is used to cover and protect wounds to support an injured part of the body or to secure objects to the skin This is a single use device Adhesive strip A small narrow flexible band of fabric plastic paper or other Adhesive strip general material coated on one side with a purpose pressure sensitive adhesive used to cover or approximate the edges of Closure wound adhesive superficial wounds or fix dressings to skin The device may include an Strip adhesive general adhesive pad and have qualities purpose such as hypoallergenic or 46 Keyword Device identifier Description Intended Use Adhesive strip butte
47. far as possible compatible with the intended purpose whilst not restricting the application of appropriate specified levels for therapeutic amp diagnostic purposes ee all Intended radiation Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks 37 inherent in the emission it must be possible for the user to control the emissions Such devices shall be designed amp manufactured to ensure reproducibility amp tolerance of relevant variable parameters 11 2 2 Where devices are intended to emit potentially hazardous visible and or invisible radiation they must be fitted where practicable with visual displays and or audible warning of such emissions 11 3 1 Unintended radiation Devices shall be designed amp manufactured in such s way that exposure of patients users and other persons to the emission if unintended stray or scattered radiation must be reduced as far as possible WAL 4b IL Instructions The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation means of protecting the patient and the user and on ways of avoiding misuse amp of eliminating the risks inherent in installation 11 5 1 Ionising radiation Devices intended to emit ionising radiation must be designed amp
48. gistered in Tanzania who has received a mandate from the applicant to act on his behalf with regard to matters pertaining to registration of devices in Tanzania The Local Responsible Person shall a Monitor the device on the market and inform the Authority immediately after the detection of any problem relating to a registered device such as serious manufacturing defects which may endanger public health b Facilitate communication between the applicant and the Authority on matters relating to the product c Handle device recalls d Provide technical support and services to users of registered device s 1 3 First time application A separate and complete product dossier in both hard copy and electronic form on a CD ROM is required for each single medical device or a medical device group or medical device family or medical device system Guidelines on Submission of Documentation for Registration of Medical Devices Page 10 of 72 Applications shall be accompanied by the following a A non refundable application fee b Five 5 Sample s of the device or artwork where applicable at the time of lodging an application for screening 1 4 Documentation 1 4 1 Language All applications and supporting documents shall be made in Kiswahili or English 1 4 2 Paper type and binding Data shall be presented on A4 and 80g m paper with readily readable letters of at least 12 font sizes Every page shall be numbered s
49. gned to prevent pressure sores e g bed sores or decubitus ulcers occurring on the parts of the patient s body which are prone to this It can equally be used as an underlay for the patient when he she is undergoing a long treatment where the body is immobilized or for disabled infirm persons who are confined to sitting lying positions This device is usually constructed as an underlay but can also be formed to accommodate the patient s body shape prominent or unprotected bony parts e g as mattresses both active and passive pads or skins of different materials 62 Keyword Device identifier Description Intended Use Protector Finger protector A device intended to be used to protect an injured finger from Finger splint further trauma during the healing process It will typically be made of durable materials e g plastic rubber or reinforced metal Projector Projector visual acuity An ophthalmic device a kind of slide projector beamer throwing Projector chart eye block letters or other symbols on a screen wall in gradually decreasing Projector ophthalmic sizes identified according to distances at which they are Vision test projector ordinarily visible used in testing visual acuity Retainer Retainer bandage A device used to stabilise attach or fix a bandage dressing in a desired Bandage clasp location This device can be a fastener clasp e g an elastic strip Bandage re
50. he functional effectiveness of the device in the experimental animal model s The rationale and limitations of selecting the particular animal model should be discussed Clinical Evidence if applicable Provide detailed information on clinical evaluation studies undertaken to demonstrate compliance of the device with the Essential Principles of Safety and Performance The clinical evaluation report should be summarized as per current GHTF guidance documents Reference e Clinical Evaluation http www ghtf org documents sg5 seg5 n2r8 2007final pdf Risk Analysis Guidelines on Submission of Documentation for Registration of Medical Devices Page 22 of 72 3 7 Provide a summary of the risks identified during the risk analysis process and how such risks have been controlled to an acceptable level Preferably the risk analysis should be based on recognised standards and be part of the manufacturer s risk management plan Manufacturing Information Provide details of manufacturing process for the device in the form of a list of resources and activities that transform inputs into the desired output The manufacturing process should include the appropriate manufacturing methods and procedures manufacturing environment or conditions and the facilities and controls used for the manufacturing processing packaging labeling and storage of the device A manufacturing process flow chart should be submitted Sufficient details must b
51. ifications for the device including as relevant accuracy sensitivity specificity of measuring and other specifications including chemical physical mechanical electrical and biological Device Verification and Validation Summarize the results of verification and validation studies undertaken to demonstrate compliance of the device with Essential Principles that apply Whenever applicable the information should cover a Engineering tests b Laboratory tests c Simulated use testing d Animal tests for demonstrating feasibility or proof of concept of the finished device e Any published literature regarding the device or substantially similar devices f Summaries or reports of tests and evaluations based on other standards manufacturer methods and tests or alternative ways of demonstrating compliance Declarations certificate of compliance to a recognized standard as applied by the manufacturer should be provided Biocompatibility if applicable Provide details of all biocompatibility tests conducted on materials used in a device At a minimum tests must be conducted on samples from the finished and sterilized device All materials that are significantly different must be characterized Information describing the tests the results and the analysis of data must be presented Guidelines on Submission of Documentation for Registration of Medical Devices Page 21 of 72 3 5 2 3 5 3 3 5 4 3 5 5 3 6
52. iling which reflect the light via reflectors mounted or mirrors depending upon the construction This device has a variety of uses and can be fixed e g to a ceiling a wall or supported on a mount It can also be part of a light system comprising more than one light head Light ear A dedicated device designed to illuminate the ear canal Ear light Light dental intraoral A dedicated light conducting system with a very small dimension Lamp intraoral at the light delivery end designed for examination dental use and to be introduced into the oral cavity It delivers light Light dental fibreoptic using fibreoptic cables The device is typically attached to a dental hand piece and is intended to directly illuminate a patient s oral structures Light dental general A dedicated light designed for purpose general purpose dental use that delivers intense focused lighting to Dental operating light the dental operating examination procedure site which usually is the Light operating dental oral cavity Loupe Loupe binocular A system of lenses mounted onto a Binoculars surgical Loupe binocular low power Loupe operating pair of spectacles worn by the surgeon during surgical intervention These function as small telescopes and provide a magnified image of the working field They can also be connected to an external light source supplying light directly through the field of 59 Keyword
53. is provided in the dossiers submitted for registration This will facilitate efficient and effective evaluation as well as approval process It will also help to avoid queries which results in unnecessary delays in giving approvals Since science is always dynamic and due to the fact that the field of medical devices keeps changing overtime the Authority will welcome inputs and comments that will help in improving the guideline M Ndomondo Sigonda Director General Tanzania Food and Drugs Authority Guidelines on Submission of Documentation for Registration of Medical Devices Page 5 of 72 Introduction This guideline has been developed to provide guidance for submission of device information to demonstrate conformity to the essential principles of safety and performance of medical devices This is in accordance with provisions of the Tanzania Food Drugs and Cosmetics Act 2003 which among other things prescribes conditions of registration of devices in Tanzania The conditions include the medical device is safe and efficacious the premises and manufacturing operations comply with the current Good Manufacturing Practices GMP requirements as provided in the regulations and the medical device complies with any other requirements as may be prescribed by the Authority In developing the guidelines reference was made from the folowing GHTF guidance documents a Principles of Medical Device Classification GHTF SG1 N15 2005 b Es
54. layered woven cotton gauze supplied in rolls that is used to bandage heads limbs and difficult to dress wounds e g burns plastic surgery or orthopaedic wounds Bandage pressure Compression dressing A piece strip or roll of fabric or plastic material designed to compress a local area e g to stop bleeding prevent oedema or provide 48 Keyword Device identifier Description Intended Use Elastic bandage support for varicose veins or ostomy aids This is a single use device Crepe Bandage Bandage traction A large strip of fabric or plastic material used to assist in exerting desirable tensile pulling forces on the body This is a single use device Bed Bed hospital A device upon which a patient rests or sleeps or upon which a patient Bed nursing may be treated It is used in hospitals institutions and home care and is used in conjunction with a patients admission and treatment or for disabled and infirmed persons Bed general purpose A mechanically designed bed to be manually operated used as a patient bed for general purposes in hospital wards with Bed hospital manual manual mechanisms to adjust the height and surface contour of the Bed hospital mechanical bed This device may include moveable and latch able side rails Bed general purpose A bed designed to be used as a hydraulically powered patient bed for general purpose in hospital wards that has
55. n FINAL pdf If more than one classification rule is applicable to the device the rules resulting to the highest risk classification shall be applicable to the device However the Authority reserves the right to decide on the class of the device 1 6 Regulatory control of medical devices Burden of regulatory controls takes into account the risk associated with medical device Therefore not all medical devices shall be subjected to product registration 1 6 1 Medical devices exempted from registration Certain medical devices due to the low risk associated with their use are exempted from product registration The List of medical devices exempted from registration and their intended purpose is provided in annex IV of these guidelines The medical devices are solely exempted for a specific intended purpose as specified in the list If the proposed intended purpose of a medical device is different from that specified in the list then the medical device shall require registration Exemption from product registration does not exempt the dealers of these medical devices from their legal obligations of keeping distribution and complaints records reporting adverse events and recalling defective and unsafe products from the market Note Every importer shall be required to submit list of medical devices exempted from registration to TFDA at the time of renewing permit for medical device business Submission of such list is a requirement fo
56. n for Registration of Medical Devices Page 16 of 72 c Summary technical documentation item 3 of the gudeline d Labelling information item 4 of the guideline e Essential requirement checklist annex II of the dossier Failure to arrange the application dossier accordingly will lead to rejection of the application Guidelines on Submission of Documentation for Registration of Medical Devices Page 17 of 72 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 DEVICE DETAILS Name s State the generic and brand name of the device Description Provide a general description on design characteristics and performance of the device The description should also include information on device packaging Category State the GMDN category of the device If the device is not categorized according to GMDN and is coded based on other system please specify Intended Use Indication State the intended use of the device and or provide a general description of the disease or condition that the device will diagnose treat prevent cure or mitigate The description of the target patient population for which the device is intended should also be included Instruction for Use Give a concise summary of information for safe use of the device including procedures methods frequency duration quantity and preparation to be followed Contraindications State conditions under which the device should not be used Warnings State
57. nternational standards deemed to offer the presumption of conformity to specific essential principles of safety and performance Technical Documentation Documented evidence normally an output of the Quality Management System that demonstrates compliance of a device to the Essential Principles of Safety and Performance of Medical Devices Verification Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled Guidelines on Submission of Documentation for Registration of Medical Devices Page 9 of 72 1 GENERAL REQUIREMENTS All applications shall be made by submitting a dully filled in application form annex 1 accompanied with prescribed information as detailed in these guidelines 1 1 Applicant An application for registration of medical device s can be made by a manufacturer or by a person who orders the device to be manufactured for sell in Tanzania The applicant shall be responsible for the product information supplied in support of the application for registration and variations thereof An applicant who is not a resident in Tanzania shall nominate a Local Responsible Person LRP A certified copy of power of attorney formal agreement or any other official authorization shall be submitted by an applicant as official proof of nomination of a LRP 1 2 Local Responsible Person A local responsible person is natural person residing in Tanzania or cooperate body re
58. on are not possible as with implants from ageing of the materials used or loss of accuracy of any measuring or control mechanism 9 3 Devices must be designed amp manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition Particular attention must be paid to devices whose intended use included exposure to flammable substance which could cause combustion 9 4 Devices must be designed and manufactured in such a way as to facilitate the safe disposal of any waste 10 Devices with a measuring function 36 10 1 Devices with a measuring function must be designed amp manufactured in such a way as to provide sufficient accuracy amp stability within appropriate limits of accuracy amp taking account of the intended purpose of the device The limits of accuracy must be indicated by the manufacturer 10 2 The measurement monitoring amp display scale must be designed in line with ergonomic principles taking account of the intended purpose of the device 10 3 The measurements made by devices with a measurements made by devices with a measuring function must be expressed in legal units conforming to the metric system 11 Ald I Protection against radiation General Devices shall be designed amp manufactured such that exposure of patients users amp other persons to radiation shall be reduced as
59. r a dealer to obtain a permit 1 6 2 All other medical devices All other medical devices shall require registration or approval from the Authority before they can be imported or supplied to Tanzania Application for registration of Class B C and D medical devices shall be prepared in accordance to requirements prescribed in item 2 3 4 and annexes I and II of this guideline Guidelines on Submission of Documentation for Registration of Medical Devices Page 12 of 72 1 6 3 Submission requirements for Class A medical devices not exempted from registration Submission of application in format prescribed for Class B C and D medical devices under item 1 6 2 above is not required for Class A non exempted medical devices The submission requirements for Class A medical devices not exempted from registration are stipulated in annex III of this guideline 1 7 Payment of fees screening and processing of applications 1 7 1 Payment of fees Every application shall be accompanied by appropriate fees as specified in these guidelines The fees specified in these guidelines shall be read mutatis mutandis with Fees and Charges Regulations and its guidelines in force at the time of application Any application that will not be accompanied by appropriate fees will not be screened or evaluated a Application Fees for Class A non exempt Medical Devices Screening Fees per dossier US 25 b Application Fees for Class B C and D Medical Devices i
60. related instruments or apparatus or other articles Label Written printed or graphic information provided upon the medical device itself Where physical constraints prevent this happening this term includes information provided on the packaging of each unit or on the packaging of multiple devices Labelling information supplied by the manufacturer Written printed or graphic matter affixed to a medical device or any of its containers or wrappers or accompanying a medical device related to Guidelines on Submission of Documentation for Registration of Medical Devices Page 7 of 72 identification technical description and use of the medical device but excluding shipping documents Manufacture Includes all operations involved in the production preparation processing compounding formulating filling refining transformation packing packaging re packaging and labelling of medical devices Manufacturer Means any natural or legal person with responsibility for design and or manufacture of a medical device with the intention of making the medical device available for use under his name whether or not such a medical device is designed and or manufactured by that person himself or on his behalf by another person s Medical Device or Devices Refer to an instrument apparatus implement medical equipment machine contrivance implant in vitro reagent or other similar or related article including any component part or
61. rfly waterproof The device is usually supplied sterile in precut sizes shapes This is a single use device Adhesive tape First aid adhesive tape Tape adhesive Tape cotton Tape gauze self adhesive Tape adhesive hypoallergenic Tape adhesive waterproof A very long and narrow flexible band of fabric plastic paper or other material coated on one side with a typically pressure pressure sensitive adhesive used to cover a surface e g small wound fix a dressing or bind attach objects e g a venflon to a patient s body part The device may also be applied in several layers one overlapping the other to cover and exert pressure on a body part e g a limb The device may have additional properties e g waterproof hypoallergenic and is typically supplied in rolls Thisisa single use device Adhesive tape remover Adhesive solvent Degreaser skin surgical Solvent adhesive type Tape adhesive removing solvent A solvent material designed to remove adhesive tape and its residue from the skin or other surfaces This is a single use device Applicator Applicator absorbent tipped A device used for making local applications to any accessible body surface It is typically designed as a slender rod of wood flexible metal or a synthetic material to which is attached a non sterile absorbent tip at one end This is a single use device Bag Ice bag A device
62. rm 1 Please check the corresponding boxes in the Encl column if any document is enclosed and indicate the respective indexes in the submission folder 2 Please check the boxes as appropriate Note Part A Particulars of Applicant Encl Al Applicant s name Address of Head Office Post Code Country Contact Person Telephone Fax E mail Website Part B Particulars of Manufacturer Manufacturer s name Bl Address of Head Office Physical address of the site Post Code Country Contact Person Telephone Fax E mail Guidelines on Submission of Documentation for Registration of Medical Devices Page 25 of 72 Website B2 Quality Management System Established by the Manufacturer Standards with which the system complies LI Iso 9001 2000 LI ISO 13485 2003 ISO 9001 2008 O Cl GMP O Others _ please specify oO System certified by and a certified copy of the certificate is enclosed Indicate areas covered by Quality Management System Device design O Production Post production processes O Others please specify Part C Particulars of Local Responsible Person LRP C1 LRP s name Address Please give the registered place of business if any Contact person Telephone Fax E mail Contact telephone for public enquiries if different from the number given above
63. s thoracic spine Orthosis thoracic TO Thoracic orthosis An orthopaedic corset that encompasses the thoracic spine region of the trunk and is used to support or immobilize deformities fractures sprains or strains of the spine through compression of the abdomen 61 Keyword Device identifier Description Intended Use Orthosis cervicothoracic spine CTO Cervico Thoracic orthosis Orthosis cervical thoracic rigid An externally applied orthopaedic appliance or apparatus used to support or immobilize deformities fractures sprains or strains of the cervicothoracic spine Orthosis cervical spine Cervical collar CO Cervical orthosis Collar cervical Support neck An externally applied orthopaedic appliance or apparatus used to support or immobilize deformities fractures sprains or strains of the cervical spine Orthosis lumbosacral spine Belt lumbosacral LSO Lumbosacral orthosis Orthosis lumbo sacral An externally applied orthopaedic appliance or apparatus _ that encompasses the lumbosacral spine region of the trunk and is used to support or immobilize deformities fractures sprains or strains of the spine Pressure pad Pressure alleviation pad Pressure pad air Pressure pad animal skin Pressure pad foam Pressure pad gel Pressure pad soft rubber Pressure pad water cushion Anti decubitus pad cushion A device desi
64. s must keep the product without deterioration in the level of cleanliness stipulated and if the devices are to be sterilised prior to use minimise the risk of microbial contamination The packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer 8 7 The packaging and or label of the device must distinguish between identical or similar products sold in sterile and non sterile condition Om Manufacturing and environmental properties If the device is intended for use in combination with other devices or equipment the whole combination including the connection system must specified performance of the 35 devices Any restrictions on use must be indicated on the label or instruction for use 9 2 Devices must be designed amp manufactured in such a way as to remove or minimise as far as possible the risk of injury in connection with their physical features including the volume pressure ratio dimension and where appropriate the ergonomic features risks connected with reasonably foreseeable environmental conditions such as magnetic fields external electrical influences electrostatic discharge pressure temperature or variations in pressure and acceleration the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given risks arising where maintenance or calibrati
65. scriptions in GMDN appear appropriate entera short description of the device D8 GMDN Code Please enter if known D9 Other common descriptions of the device D10 Intended use of device Class of the medical device LI Class A D11 Class B O Class C O Class D D11 Reasons for classifying the device as Class A B C or D device Guidelines on Submission of Documentation for Registration of Medical Devices Page 28 of 72 D12 History No previous recalls reportable adverse incidents banning in other countries or post market surveillance studies L Yes Please tick the appropriate boxes and provide details Recalls completed or in progress Any reportable adverse incidents bearing implications to the device The device banned previously in other countries Pro active post market surveillance studies OOOd D13 Performance and Safety International or national standards with which the device complies Please enclose copy of the standard Part E Marketing Approvals in Foreign countries El Mention the countries where the device has obtained marketing approvals Please enclose certified copy of valid marketing authorization E2 Mention the countries where the device approval is still pending Part F Declaration of conformity DoC F1 Submit a written declaration of conformity The DoC should contain the Guidelines on Submission of Documentation for
66. sential Principles of Safety and Perfomance of Medical Devices GHTF SG1 N41R9 2005 c Principles of Conformity Assessment of Medical Devices GHTF SG1 N40 2006 d Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices GHTF SG1 N011 2008 In addition the Medical Devices Regulations of Canada the Common Submission Dossier Template CSDT of the Asian Harmonization Working Party AHWP and the Medical Devices Regulations Global overview and guiding principles of WHO were also used This guideline apply to products that fall within the definition medical devices or devices except in vitro diagnostic devices The guideline is divided into the following sections a General Requirements b Device Details c Summary Technical Documentation d Labelling Requirements e Annexes It should be noted that the amount of detail and information that will be needed in the Summary Technical Documentation may vary considerably with the risk class of the device concerned Assessment of dossiers submitted will be based on this guideline Applicants are also requested to read the guideline together with the Tanzania Food Drugs and Cosmetics Act 2003 and Regulations made thereunder Guidelines on Submission of Documentation for Registration of Medical Devices Page 6 of 72 DEFINITION OF TERMS In the context of this guideline the following terms shall be d
67. stresses which can occur during normal conditions of use The devices must be designed manufactured amp packed in such a way that their characteristics amp performances during their intended use will not be adversely affected during transport amp storage taking account of the instructions amp information provided by the manufacturer Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended DESIGN AND MANUFACTURING REQUIREMENTS 32 7 1 Chemical physical amp biological properties The devices must be designed amp manufactured in such a way as to guarantee the characteristics amp performance referred to in Section 1 on the General Requirements Particular attention must be paid to choice of materials used particularly as regards toxicity and where appropriate flammability the compatibility between the materials used and biological tissues cells amp body fluid taking account of the intended purpose of the device T2 The devices must be designed manufactured amp packed in such a way as to minimise the risk posed by contaminants amp residues to the persons involved in the transport storage amp use of the devices amp to the patients taking account of the intended purpose of the product Particular attention must be paid to the tissues exposed amp the duration amp frequency of the exposure T
68. t provides a specialized light to illuminate a surgical site over a prolonged period of time providing the surgeon s with optimal visualization of small low contrast objects at varying depths or through small incisions In addition to providing enough illumination and minimizing the emission of heat to the site the light will reduce shadows and produce minimal colour distortion which helps the surgeon evaluate tissues and structures It typically consists of one or more light bulb s which reflects the light via reflectors or mirrors depending upon the construction This device will typically be part of a light system comprising more than one light head Light examination hand held battery powered Light examination medical battery powered A small hand held battery powered light used as a personal light source to provide light for local examination inspection and treatment of the patient It may be torch like in design and can have a magnifying lens to augment the lighting effect It will typically be found in an examination room doctor s surgery or office on a 58 Keyword Device identifier Description Intended Use medical trolley or part of an emergency kit Light Examination A device that provides light to illuminate the site of examination or Examination light treatment of the patient It typically consists of one or more light bulb s Light examination ce
69. tainer with opposing gripping teeth hooks or a tubular elastic net It is Bandage elastic net typically used on patients sensitive or allergic to adhesive tape This device is single use Shield Shield eye A mechanical shield used for Eye patch protection of one or both eyes following surgery or trauma These shields usually are plastic or metallic Shield face Goggles A clear transparent guard worn over the face eyes to protect the healthcare worker from blood and other body fluid splashes while performing a clinical procedure Shield hip A mechanical guard worn over the hip area to prevent against hip fractures in the event of a patient fall Shield wound Protector wound A mechanical shield that is designed to form a protective structure over a wound It may be 63 Keyword Device identifier Description Intended Use cage like and will allow exposure to air and permit access to the injured area while protecting against accidental damage The device is disposable Shoe Orthotic shoe Orthopaedic footwear that is intended to support align prevent Orthopaedic shoe or correct deformities of the feet to help improve their function Orthosis corrective shoe Shoe corrective Cast boot A boot like cover for a foot enclosed in a leg cast This device is generally equipped with a waterproof covering an outer sole for walking and closures for eas
70. tention Fees Class A US 25 Class B US 40 Class C US 60 Class D US 100 1 7 2 Screening of application The application will be screened before can be accepted for evaluation to ensure that there are no major deficiencies that would hinder the evaluation If any major deficiencies are identified during the screening an input request will be made to the applicant The applicant will be required to submit all The requested information and material identified in the input request within 60 calendar days from the date of request Any deficiencies indicated must be adressed before the application can be accepted for evaluation If the applicant anticipates difficulty in responding in full or within the specified timeframe they should contact the authority to discuss the request for information as soon as possible after receipt of the input request for information clarification If the applicant fails to provide all requested information or the submitted information is incomplete deficient or contains unsolicited information the application will be rejected If the applicant wishes to resubmit the application at a future time it will be processed as a new application The following applications will be rejected at screening stage a Application for device products that are not medical devices b Application not submitted in the prevailing required format c Low risk Class A medical device applications submitted via the medi
71. ternum A strip or roll of fabric or plastic material designed to support the sternum Wrist binder A strip or roll of fabric or plastic material designed to support the wrist joint Board Board arm A firm device in which a patient s arm is placed for stabilization to maintain the patency of an intravascular catheter e g those connected to an intravenous or intra arterial line It is typically constructed of expanded polystyrene with a plastic coating and can be straight or curved to accommodate the patient s arm wrist Board cardiac A flat rigid device that is placed 50 Keyword Device identifier Description Intended Use compression Board cardiopulmonary Cardiac compression board CPR board cardiopulmonary resuscitation under a patient to instantly give the necessary support required for the application of cardiopulmonary resuscitation This device is typically suitable for use when an acute situation has arisen and the patient is lying in his her bed Board spinal Spine board A flat stiff device placed on a stretcher to ensure spinal immobilization when a spinal injury is suspected Bottle Bottle heating cooling A flexible container typically with a relatively narrow neck that is Hot cold water bottle usually filled with either hot or cold water or ice for the purpose of applying heat or cold therapy to an area of the body
72. the nose typically after a fracture or treatment It may function as a truss like support on the outside of the nose Stocking Stocking anti oedema A device designed like a stocking or arm leg Anti oedema stocking arm leg Compression stocking Legging compression non inflatable tube like elastic bandage for reducing or preventing swelling caused by circulation problems It exerts a counter pressure upon the limb 65 Keyword Device identifier Description Intended Use Stocking compression Compression socks Stocking medical An elastic limb support shaped as a support stocking that is worn on the upper or lower extremity to support Sock fracture correct prevent deformity or to align body structures for functional Stocking elastic improvement Stretcher Stretcher A device on which a patient lies for Bed stretcher Stretcher mobile Stretcher powered Stretcher transfer Stretcher wheeled powered Stretcher wheeled Stretcher hospital transport or reclines after treatment It may have a wheeled undercarriage which can _ be foldable Stretcher ambulance Ambulance stretcher Stretcher mobile ambulance A stretcher specially adapted for use with an ambulance vehicle including e g aeroplanes helicopters or boats It will typically have an undercarriage which folds automatically when it meets the vehicle as it is being pushed in as well as locking
73. um Class B and C and high risk Class D product registration route or vice versa Guidelines on Submission of Documentation for Registration of Medical Devices Page 14 of 72 1 7 3 Processing of applications Once an application has been accepted and evaluation fees paid the processing of application will take 270 calender days This will involve evaluation of application request for additional data samples and clarification of some issues where applicable Once a query or a request has been raised the processing shall halt until after the response to the query has been received If no response to the query or request has been received within six months the application will be rejected As part of evaluation of the medical device pre registration GMP inspection or Quality System audit may be conducted to verify compliance thereof 1 8 Registration of the device When a device is found to have complied with all the prescribed registration requirements the applicant will be informed to that effect A certificate of registration together with such conditions as the TFDA may determine shall be issued Registration of a device shall be site specific 1 8 1 Validity of registration The registration of a medical device shall be valid for five 5 years unless suspended or revoked by TFDA or terminated by the registrant The validity of registration shall be subject to a payment of annual retention fees as prescribed in current f
74. ust include an alarm system to signal any power failure 12 4 Devices intended to monitor one or more clinical 39 parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient s state of health 12 5 Devices must be designed amp manufactured in such a way as to minimise the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment 12 6 12 6 1 Protection against electrical risks Devices must be designed amp manufactured in such a way as to avoid as far as possible the risk of accidental electric shocks during normal use amp in single fault condition provided that the devices are installed correctly 12 7 12 7 1 Protection against mechanical amp thermal risks The devices must be designed and manufactured in such a way as to protect the patient amp user against mechanical risks connected with for example resistance stability amp moving parts 12 7 2 The devices must be designed amp manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices taking account of technical progress amp of the means available for limiting vibrations particularly at source unless the vibrations are part of the specified
75. y application and removal Shoe Cast A shoe designed to be worn over a foot ankle that is encased in a cast in order to protect the cast material and provide support Sling Sling A hanging bandage or other material that is usually suspended Sling arm from the body or another structure and used to support and limit the Sling knee range of motion of an injured limb during the healing period or to Sling leg support and limit the range of motion of a body in transport Clavicle strap Spectacles Spectacles An optical ophthalmic device Astigmatism spectacles Eyeglasses Farsightedness spectacles Nearsightedness spectacles consisting of a spectacle frame that contains a pair of spectacle lenses eyeglasses 64 Keyword Device identifier Description Intended Use Presbyopia spectacles Special spectacles Vision corrective spectacles Splint Splint A rigid or semi rigid device that serves to immobilise an injured Splint traction body or body part It is generally placed externally along the injured Splint wire board limb or body part It is typically made of plastic moldable plastic Splint extremity external wood or metal Splint hand finger Splint moldable Splint moulded aluminium Splint moulded plastic Splint padded stays Splint air Splint nasal external A rigid or partially rigid device intended for use externally for the immobilization of parts of

TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON

Contents

Download Pdf Manuals

Related Search

Related Contents