医療用具等の添付文書記載要領ガイド策定
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26. 33 OO POOO000000000000000000000 OUUUU 2000 2 FINAL DOCUMENT Title Labeling for Medical Devices Endorsed by The Global Harmonization Task Force Date February 24 2000 original signed by Beth Pieterson GHTF Chair The document herein was produced by the Global Harmonization Task Force which is comprised of representatives from medical device regulatory authorities and trade as
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94. LABELLING FOR MEDICAL DEVICES GENERAL PRINCIPLES Labelling serves to communicate safety and performance related information to users of medical devices and or patients as well as to identify individual devices Such information may appear on the device itself on packaging or as a packaging insert or as information for use Consistent world wide labelling requirements would offer significant benefits to the manufacturer patient or consumer and to Regulatory Authorities To achieve this purpose the following principles are recommended As far as it is practical and appropriate the information needed to identify and use the device safely should be provided on the device itself and or on the packaging for each unit and or on the packaging of multiple devices If individual packaging of each unit is not practicable the information should be set out in theleaflet packaging insert or other means supplied with one or multiple devices The format content and location of labelling should be appropriate to the particular device and its intended purpose Country specific requirements for labelling text content or the format of labels or labelling should be kept to the minimum and where they currently exist eliminated as the opportunity arises Taking into consideration the type of user anticipated for the device national language requirements should be kept to a minimum The use of internationally r
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101. Bau 2000000000000000 0000000 31 18 2000 EE 70 10 0 i0 00D D u 2 4 OO 3 100000000000000000 5 3 200000000000000000 9 3 13 000000 GHTFO Labelingfor Medical Devices 16 3 35 woooooooooooooooooo 38 DE ODODE Ee AE m 43 47 50 52 52 OO 12 20 200008
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111. batch code or serial number Any special storage and or handling conditions on the external packaging Any warnings and or precautions The performance intended by the manufacturer and any undesirable side effects The information needed to verify whether the device is properly installed and can operate correctly and safely plus details of the nature and frequency of preventative and regular maintenance replacement of consumable components and calibration needed to ensure that the device operates properly and safely during its intended life Details of any further treatment or handling needed before the device can be used 6 0 sterilization final assembly calibration etc Where applicable k An indication that the device is sterile and necessary instructions in the event of damage to sterile packaging and where appropriate description of methods of re sterilization 37 OO 2000000000000000000000008 1 An indication that the device has been spedfied by the manufacturer for single use only m An indication that the deviceis for use by a singleindividual and has been manufactured according toa written prescription or pattern i e it is custom made n An indication that the device is intended for dinical and or performance investigations prior to pladngit on the market o Anindication that the device is intended only for presentation or demonstration purpose
112. warnings and any precautions to be taken These details should cover in particular i Precautions to be taken in the event of changes in the performance of the device ii Precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields external electrical influences eledrostatic discharge pressure or variations in pressure acceleration thermal ignition sources proximity to other devices etc iii Adequate information regarding any medidnal product or products which the device in question is Approved by the Global Harmonization Task Force reference GHTF SG1 N020R4 38 OO 2000000000000000000000008 designed to administer induding any limitations in the choice of substances to be delivered iv Precautions to be taken against any spedal unusual risks related to the disposal of the device v Any medicinal substances incorporated into the device as an integral part of the device vi Degreeof accuracy daimed for devices with a measuring function vii Any requirement for special fadlities or special training or particular qualifications of the device user 39 OO 12 GHTF SG1 N009R5 DRAFT OF 13 OCTOBER 1999
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117. ecognised i e standardised symbols should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the patient or user Where the meaning of the symbol is not obvious to the device user who with some products could be a member of the public it should be described in words associated with the symbol Information on device use and instructions may be provided to the user in various media and by several means such as printed documents through a display screen incorporated into the device trans telephonically magnetic or optical media etc Whatever the media or the means information should be targeted to the anticipated user population Instructions for use should be written in terms readily understood by the intended user Instructions may not be needed or may be abbreviated for devices of low or moderate risk if they can be used safely and as intended without any such instructions Regulatory Authorities and industry should encourage the development and use of international labelling guidelines for medical devices Regulatory Authorities that are developing regulatory requirements to address device labelling or modifying existing requirements are encouraged to consider the adoption of these recommendations This will help minimise the diversity of labelling requirements world wide and facilitate the process of harmonization In some regulatory schemes promotional labelling materials may be con
118. s p If the deviceis to be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose suffident details of its characteristics to identify the correct devices or equipment to usein order to obtain a safe combination q If the device is implantable information regarding any particular risks in connedion with its implantation r Information regarding the risks of redprocal interference posed by the reasonably foreseeable presence of the device during spedfic investigations or treatment e g electrical interference from electro surgical devices or magnetic field interference from Magnetic Resonance magers s Ifthedeviceis reusable information on the appropriate processes to allow reuse induding cleaning disinfection packaging and where appropriate the method of re sterilization and any restriction on the number of reuses Where devices are supplied with the intention that they be sterilized before use the instructions for deaning and sterilization should be such that if correctly followed the device will still comply with the Essential Prindples of Safety and Performance of Medical Devices t If the device emits radiation for medical purposes details of the nature type intensity and distribution of this radiation The instructions for use should also indude where appropriate details allowing the medical staff to brief the patient on any contra indications
119. sidered labelling Such materials are beyond the scope of this document 36 OO 2O00000000000000000000008 CONTENT OF LABELLING The labelling should bear the following particulars In general a S The name or trade name and address of the manufacturer and the intended purpose user and patient population of the device where these are not obvious For imported devices the label or the outer packaging or instructions for use may be required to contain in addition the name and address of either the importer established within the importing country or of an authorized representative of the manufacturer established within the importing country Sufficient details for the user to identify the device or where relevant the contents of any packaging An indication of either the batch code lot number e g on single use disposable devices or the serial number e g on electrically powered medical devices where relevant and to allow appropriate actions to trace and recall the devices and detachable components An indication of the date until which the device may safely be used i e put into service expressed as the year and month eg on single use disposable devices wherethis is relevant For devices other than those covered by d above and as appropriate to the type of device an indication of the date of manufacture This indication may be included in the
120. sociations The document is intended to provide non binding guidance to regulatory authorities for use in the regulation of medical devices Endorsement by the current Chair of the Global Harmonization Task Force signifies acceptance by consensus of the document amongst members of the GHTF Steering Committee as a document to be promoted by all members of the Task Force There are no restrictions on the reproduction distribution translation or use of this document however incorporation of this document in part or in whole into any other document does not convey or represent an endorsement of any kind by the Global Harmonization Task Force OO 2O00000000000000000000008 GLOBAL HARMONIZATION TASK FORCE STUDY GROUP 1 LABELLING FOR MEDICAL DEVICES This document has been developed to encourage and support global convergence of regulatory systems and the means of achievement It is intended for use by medical devices regulators Conformity Assessment Bodies and industry and will provide benefits in establishing in a consistent way an economic and effective approach to the control of medical devices in the interest of public health The document will be of value to countries developing or amending regulations The regulatory requirements of some countries may not at present reflect the contents of this document 35 OO 2O00000000000000000000008
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