Home
シンガポールにおける 医療機器法規制とシステム
Contents
1. HB e Pacific Healthcare 2001 2005
2. v DT PA 29 Copyright 2010 JETRO All rights reserved 5 5 1 1 ANI Da uana
3. GDPMDS Good Distribution Practice for Medical Devices in Singapore 2009 GDPMDS Good Distribution Practice for Medical Devices in Singapore 10 Overseas ships medical H 1 ships ship medical medical Orders devic device ical tores ores medical device medical 1 i 23 medical d device A device Local medical device lt Contract 3rd party logistic Service i dealer out source company provider Delivers medical i Delivers a device Orders medical Local device Hospital mm
4. 2 3 1 11 1 HSA Health Products Act 2008 2010 8 1 2GN 12 Guidance on Grouping of Medical Devices for Product Registration 10 Copyright O 2010 JETRO All rights reserved 2010 8 Radiation Protection Act 2011 7 HREOC
5. Copyright 2010 JETRO All rights reserved 2 2 1 Health Products Act Health Products Act 2007 2 Health Sciences Authority HSA HSA Health Products Regulation Group 1 HSA HSA Board Chief Executive Officer Divisi Health Products Pre marketing Regulation Group Vigilance Compliance amp Enforcement Tr da Corporate Headguarters Divisi Corporate Development amp Operations Human Capital amp Legal Departments Corporate Communications Quality Management Professional Quality Strategy amp Business Trans
6. 2 3 2 3 5 DE LOC 7 BB
7. S X 1 094 e Raffles Medical 2011 2009 7 640 S 1982 1997 Raffles Hospital 2002 2003 31 Copyright 2010 JETRO All rights reserved Parkway Health LG 7 AR 2 1 861 DS
8. EOE KA E 7 E 42 Copyright 2010 JETRO All rights reserved 23 E Bluestone Corporation
9. http www hsa gov sg publish etc medialib hsa library health products regulation trade announcements files Par 67312 File dat Health Products Act 2007 pdf https www hsa gov sg publish etc medialib hsa library health products regulation legislation health pr oducts_act Par 8018 File dat HEALTH 20PRODUCTS 20 MEDICAL 20DEVICES 20REGULA TIONS 202007 pdf http www hsa gov sg publish hsaportal en health products regulation medical devices regulatory guid ances html 1 Copyright 2010 JETRO All rights reserved Hl 2002 4 Voluntary Product Registration Scheme 2007 2 Health Products Act Health Products Act 1 2007 11 UE
10. GN 12 Guidance on Grouping of Medical Devices for Product Registration PVC PU 53 Copyright O 2010 JETRO All rights reserved IVD IVD IVD IVD IVD 7 IVD
11. 2000 v E H UALEN LT EE Tr 20 3M Healthcare 2009 2010 2011 Agilent defibrillator as Baxter Becton Dickinson 1999 R amp D
12. 10 ii CERES ani diia I 50 Copyright O 2010 JETRO All rights reserved 2 2 11 12 9 10 11 51 Copyright O 2010 JETRO All rights reserved 16 13
13. HSA GN 22 Guidance to the List of Medical Devices Exempted from Product Registration 2010 8 HSA 2 4 2 4 3 HSA EX HSA HSA Client Registration and Identification Service CRIS Company Account CRIS CRIS GR DH 3 CRIS 13 zi Je HSA
14. Lozon S Pte Ltd Sicmens En Pharmaforte Pte Ltd Scanmed Technology MER FUA XBR CT ECG I CU S Pte Ltd Tyco Healthcare Pte Ltd Tyco 6 4
15. GN 15 R3 Guidance on Medical Device Product Registration HSA A ASEAN CSDT actve TEC60601
16. lt Field Safety Corrective Action FSCA Adverse Event 2 2010 4 30 2008 11 3A ASEAN CSDT 2010 5 2010 4 30 3B 2010 8 1 DHE MA WIT C D OFF HSA
17. E SingHealth 1 Tan Tock Seng National Healthcare NHG Group Purchasing Office
18. H d E 19013485 HSA Good Distribution Practice for Medical Devices in Singapore GDPMDS ISO13485 ISO13485 ISOI3485 A5 ISO13485 GDPMDS GDPMDS
19. gt ASEAN ASEAN Global Harmonization Task Force GHTF 2010 4 1 T Copyright 2010 JETRO All rights reserved Radiation Protection Act 2011
20. 1 H ak ya i en Bil HIV HIV Enzyme hnked ImmunoSorbent Assay ELISA Test Kit i fi HIV
21. TG GN 15 R3 Guidance on Medical Device Product Registration HSA 8 CSDT CSDT CSDT 272 1718 IJAB 774D 17218 No C amp D IVD VD AVD AVD IVD 3 0 m 4 2 4 3 1 ECD 17 Copyright 2010 JETRO All rights reserved CSDT CSDT JJA B 1218 IVD IVD 774 D IVD C amp D IVD 7
22. NTU School of Materials Science and Engineering 2005 gt 179 Biosensors International Ltd 2000 4 C E C SE RI E DES 2008 4 E 2005 E1 CE WANI 3 JWMS 50 1 2007 JW 1 Cadi Scientific Pte Ltd Ww Zs
23. Fund CPF 3 CPF E E ae
24. E b c 1 d e dU g 7 JA HJ EU Ex E zu BIZ Eo TARA ILA Th Global Harmonization Task Force GHTF
25. ISO1348 ISO1348 A A at GDPMDS A ri H HSA HSA GDPMDS Briefing on GDPMDS Secondary Assembly for industry members 2 July 2010 HSA Medical Device Technical Specification TS 01 Good Distribution Practice for Medical Devices in Singapore Requirement c BAROT HSA Medical Device Industry Briefing 26 April 2010 4 2011 8 Products Act 11 2010 8 GDPMDS
26. 500 Ya 2010 9 Crossborder Research Pte Ltd
27. CSDT KT 15 Copyright O 2010 JETRO All rights reserved CSDT CSDT i CSDT E 5 775 YIR 775 775 0 B C D B C amp D 3 0 4 1 1 pue CEE ST LA 4 2 4 3 ELD 4 3 1 E
28. 3 2 C I F HS 10 HS 9018 9019 ps 5 EDB 22 Copyright 2010 JETRO All rights reserved 9020 9021 9022 5 2009 35 4 276 5 t
29. AH 1 2010 L EDB 37 GE Copyright O 2010 JETRO All rights reserved 0 2
30. 14 4 1 Lr GN 13 R1 Guidance on the Risk Classification of General Medical Devices HSA 52 Copyright 2010 JETRO All rights reserved 3 A
31. Radiation Protection Non ionising Radiation Regulations 2011 8 fT KER DS WAHL 7 HIKE SAU CV 5 Radiation Protection Ionising Radiation Radiation Regulations Li F7H31 H3 Health Products Act x 51 ka N a E dB oft RTL 9 1 M TAS 8 Health Products Act First Schedule 11 Copyright O 2010 JETRO All rights reserved MRI E E Health Health Products
32. 12 Copyright O 2010 JETRO All rights reserved b 6 c 12 d 12 3 Radiation Protection Act CX MRI Radiation Protection Acts 2011 7 31 A HSA A
33. 1999 QNHG SHS 2 2 5 15 QNHG Tan Tock Seng Hospital Ins
34. 6 LY lt gt 1 8 nee LE Aa a or B gt Copyright O 2010 JETRO All rights reserved 2 2 7 lt gt MARK
35. EM SE TEE POS 4 3 2 T 4 4 16 Copyright O 2010 JETRO All rights reserved E CSDT 24 734 ITA ITA B C D B C amp D 4 5 4 6 ASEAN CSDT Wo abe
36. 1 Eels 1 A B HSA GN 12 Guidance on Grouping of Medical Devices for Product Registration 6 11 uz 83 9 Copyright O 2010 JETRO All rights reserved
37. 2 A KUZI FA SEF B C D invasive GN 13 R1 Guidance on the Risk Classification of General Medical Devices HSA He E KI Wr EL BUYS 2 JARo Fe active GHI iX DAA MERU EITA TE T E implantable IVD EU
38. 2009 4 2009 HS 9022 25 8 9018 DEJ HS 9021 41 4 LL J WEH ME HS 9018 26 HS 9020 1 2 0 H HS 9021 95 E HS 9021 HS 9018 World Trade Atlas H HS 100 S 13 HS 2007 2008 2009 9018 1 279 14 1 141 84 1 186 39 24 Copyright 2010 JETRO All rights reserved 9019 14 99 13 32 47 67 9020 6 47 6 11 7 05 9021 952 80 903 43 889 27 9022 34 77 31 93 34 25 Bi 2 288 17 2 096 63 2 164 64 World Trade Atlas B 8
39. 4 HT r1 M 20 Copyright 2010 JETRO All rights reserved e nul HSA KIZEE NAI I rA BEDI DN HMO AA DR Re CI SIVA 9 270 20 working 20 working working days days days E HH GN 15 Guidance on Medical Device Product Registration HSA T
40. 2 4 2 1 amp HSA RegistrranD lL HSA MEDICS B C D A 4 B C D 14 Copyright 2010 JETRO All rights reserved l PASADA HSA i GN 15 R3 Guidance on Medical Device Product Registration HSA HSA MBDICS ASEAN CSDT
41. Diethelm Singapore Pte 150 Ltd Gold Lite Pte Ltd IT Medtronic IDS Medical System Li amp Fung Group Inchcape Buying Pte Ltd Services 1995 Li amp Fung Group IDS Group IDS Group
42. A ntermediate and China Copyright O 2010 JETRO All rights reserved Healthcare Limited ANG 1 19 2006 2007 2008 4E 5 5 5 4 4 4 62 62 64 4 4 4 I uil 7 1 E 1 8 5 3 NTUC Fairprice Unity NTUC Healthcare Cold Storage Giants Dairy Farm Guardian Health Beauty
43. 10 amp 3 43 Copyright 2010 JETRO All rights reserved 24 Phone Fax Email Century Tokyo Leasing http www ctl co jp english network sg inde T 65323436 Singapore Pte Ltd x html F 65330117 Email colin ctls com sg m takemura ctls com sg ORIX RENTEC http www orix rentec com sg T 67454515 SINGAPORE PTE F 67456595 LTD Email sales orix rentec com sg Sumitomo Mitsui Finance http www smfl co jp T 62242955 62242956 and Leasing F 62253570 H LEE 3 Parkway Health 11 5 7 863 S 135 S 514 8 000S Parkway Health 434 2 000S 149 3 000S kvl amp 4 Raffles Medical 11 7 863 S
44. 30 n 3 1995 Gold Lite J 21 30 LifeScan Singapore Johnson amp 1 Johnson amp Johnson Johnson Medical Pte Ltd 2 GE Healthcare GE Healthcare Pte Ltd Siemens Siemens Medical i 3 Healthcare Instruments Pte Ltd Siemens Healthcare Diagnostics Pte Ltd Cardinal Health 4 Car
45. 1 Td E 4 Re RMT SOLES CEU 2009 20 1 554 S E 3 4 Lav f nu EMAIL 2318 8 480 DS PVE 7g o Cv 73 E 31 7 400 S 1 TE co Is Am 11 C IF 2007 2008 2009 3 187 20 3 117 60 3 173 50 2 514 97 2 363 99 2 384 80 3 571 18 3 462 70 3 542 76 2 130 99 2 018 89 2 015 54 3 3 HS VY ARMIES OPEC
46. 2009 10 667 FS E 1005 S ll Economic Survey of Singapore World Trade Atlas RAYE 12 100 S HS 2007 2008 2009 2007 2008 2009 2007 2008 2009 9018 1 572 70 1 338 19 1 264 84 980 13 1 003 90 1 003 21 592 57 334 30 261 63 16 23 Copyright 2010 JETRO All rights reserved 9019 92 45 84 66 111 34 49 29 43 28 54 21 43 16 41 38 57 13 9020 40 33 33 91 35 56 28 34 25 01 23 54 11 99 8 89 12 01 9021 460 85 468 76 443 50 30 05 33 34 27 02 430 79 435 42 416 49 9022 348 64 438 47 529 56 195 19 260 54 270 14 153 45 177 93 259 41 2 514 97 2 363 99 2 384 80 1 283 01 1 366 07 1 378 13 1 231 96 997 92 1 006 67 World Trade Atlas H 7
47. 2398 FREI 5 hb 7 GPO http gpo nhg singhealth com sg Tender GPO pub index html 1 National Healthcare http www gpo nhg com sg 28 Copyright O 2010 JETRO All rights reserved
48. 2010 1 2008 2007 MART TUN LMA International non stimulating airway support for patients during surgery FSH 2005 KAWI AI laryngeal masks for non invasive and 2000 Forefron t Medical Tecnology Medtronic
49. 10 GN 13 R1 Guidance on the Risk Classification of General Medical Devices 7 Copyright O 2010 JETRO All rights reserved 3 A Clinical Chemistry Analyser prepared selective culture media B AAI MTSU AZ ASHE B12 Vitamine B12 Pregnancy self testing Anti nuclear antibody amp fK Urine test strips IFAC Blood glucose self testing HLA HLA Typing PSA A PSA Screening Rubella IFAD HIV HIV Blood Donor screening HIV
50. 32 DERE 1 1 Copyright 2010 JETRO All rights reserved 5 BDF 620 Practitioner Medical Council 2 2008 4 General Specialist
51. 56 Copyright O 2010 JETRO All rights reserved 4 No Aja Registrars Pte Ltd Bsi Management Systems Singapore Pte Ltd Bureau Veritas Certification Singapore Pte Ltd Das Certification Singapore Pte Ltd Guardian Independent Certification Pte Ltd Lloyd s Register Ouality Assurance Ltd No 4 Certification International Singapore Pte Ltd Address 371 Beach Road 16 07 KeyPoint Singapore 199597 Telephone No 65 6294 0308 Facsimile No 65 6294 5797 Contact Person Mr Peter Sim Email Address peter 2aja singapore com Date Accredited 18 May 2009 Website http www aja singapore com Address 3 Lim Teck Kim Road 10 02 Singapore Technologies Building Singapore 088934 Telephone 65 6270 0777 Facsimile 65 6270 2777 Contact Person Mr Alwi Bin Abdul Hafiz Email Address alwi hafiz bsigroup com Date Accredited 18 February 2009 Website http asia bsi global com Address 1 Maritime Square 09 66 Lobby C Harbourfront Centre Singapore 099253 Telephone 65 6275 2886 Facsimile 65 6275 2776 Contact Person Mr Shaji Krishnan Email Address krishnan shaji sg bureauveritas com Date Accredited 20 May 2009 Website http www certification bureauveritas com Address 7500A Beach Road 16 317 The Plaza Singapore 199591 Telephone 65 6299 9001 Facsimile 65 62
52. 1372 GEER Intima bioM rieux 5 E hue 2008 Bio Rad Laboratories 3 Ws 2007 4 Edwards Lifesciences p Ev ES H 2005 tissue heart valve HH H 2005 2008 Lic 36 Copyright 2010 JETRO All rights reserved Hill Rom 8 F ACRA Es
53. 135 S 10 10 S 6 5 EDB EDB Economic Development Board EDB 250 North Bridg
54. 6 2 1 Bil 1 GN 12 Guidance on Grouping of Medical Devices for Product Registration GN 12 Guidance on Grouping of Medical Devices for Product Registration 6 PWS Flee Pee y nul IH GN 12 Guidance on Grouping of Medical Devices for Product Registration GN 12 Guidance on Grouping of Medical Devices for Product Registration 3 2 3
55. 8000 S 2009 DI 2009 10 3 2011 ResMed H 2009 5 REIR AE BA 1 Siemens Medical Instruments 2000 7 JE Welch Allyn ayaa PE Bs GE i 1 R amp D RAATS 2010 West Pharmaceuticals 2007 4500 S
56. 1 5 Do 2007 Health Products Act 2010 8 EU TWH n
57. kk 27 Loi or e LL th RR hk 30 KAB NENG aga sana a aaa la pen aa a aa A ED a a a EN TE A a al Na aa aa ka Ga 46 WA AGING SR S e toro rh ettari 47 TI ege NON 53 4 CU 1p e LEE 57 M CE NOE o n 59 6 61 OR 63 IAE SOA a Ve E DA RES sa vesc arr E Ae 65 Copyright O 2010 JETRO All rights reserved 1 2000
58. 54 Copyright O 2010 JETRO All rights reserved 1 55 Copyright O 2010 JETRO All rights reserved 7 IVD ien TREP A B 6 IVD IVD
59. CRIS T Copyright 2010 JETRO All rights reserved Singapore Government Integrity Service Excellence IS A CONTACT INFO FEEDBACK SITEMAP sh Health Sciences Authority CRIS ONLINE APPLICATION NEW Application Login ID S2669394B Ref No 1008142 Logout APPLICATION FORM 1 Applicant Info 2 Company Profile 3 Business Activity s 4 CRIS Administrator 5 Declaration and Submission Fields marked with asterisks are mandatory Name Mr NRIC Passport Designation Tel No Fax No HP No Email Address Receive Alert Notification By Email Fax sms CRIS HSA MEDICS Medical Device Information and Communication System 241 ISO13485 Good Distribution Practice for Medical Devices GDPMDS A HSA MEDICS
60. 30 Medical Product Outsourcing July August 2009 WTN News August 10 H J HA Biosensors Interventional Technologies Pte Ltd 22 Amaranth Medical amp
61. Radiation Protection Act 2012 1 1 HSA O A amp HSA HSA 2010 4 30 2010 8 HSA HSA Authorisation Route a 6
62. a A lt gt 8 lt o 0 9 NY 4 X M X N t 0 v Copyright 2010 JETRO All rights reserved 9 i THY REX 4 9 ii C 1 2 10 i
63. 2009 11 096 8 296 8 7 9 6 World Trade Statistics 14 5 2009 100 5 HS 9018 490 58 112 62 147 99 79 68 50 40 9019 19 94 1 56 7 07 25 13 5 00 9020 12 21 1 13 1 17 1 83 0 16 9021 49 32 38 75 2 59 83 60 140 40 9022 161 50 108 06 69 03 16 13 0 24 733 55 262 11 227 85 206 37 196 20 World Trade Statistics 26 Copyright 2010 JETRO All rights reserved 4 4 1
64. Ei zu 18 Copyright 2010 JETRO All rights reserved CSDT CSDT A E ITA 172 B IJAB 774D 73A4B No C amp D IVD VD IVD AVD VD MA 4 4 4 5 s 4 6 boris ASEAN CSDT in vitro EA RSC BAT 2 Si RE OC 2
65. 1970 63 HKD 2008 1999 2009 6 ZH j 4 469 Nursing Home 7 713 10 1 7 18 1999 2004 2005 2006 2007 2008 2009 2 979 4 533 4 727 4 746 4 869 4 829 4 974 1 490 1 801 2 018 2 238
66. X Lo EDB 2E n ATS CE FDA 41 Copyright 2010 JETRO All rights reserved Eminence Medical Equipment Pte Ltd Fong s Engineering amp Manufacturing Pte Ltd Glucostat Systems Pte Ltd 2000 mon invasive blood glucose monitoring
67. CSDT Executive Summary CSDT e HSA GN 11 ProductOwner HSA GN 15 Annex 5 BEU 1 Abridged evaluation
68. GN 15 R3 Guidance on Medical Device Product Registration HSA HSA HSA 30 HSA j 30 LIN 19 Copyright 2010 JETRO All rights reserved 5 A OB gh RRO Herr
69. HIV Blood diagnostic LI HZ TI GN 14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Device HSA Bij 3 12 CT Copyright O 2010 JETRO All rights reserved ffi UV
70. Medical Device Regulatory Framework Implementation updates October 2008 HSA 4 2 27 Copyright 2010 JETRO All rights reserved 70 0008 1 3 000S 3 001 GeBiz www gebiz gov sg 70 001S 30018 GeBiz Group Procurement Office GPO 233 GPO
71. 220 A CHS EH EE 7 841 A E Singapore ph 3 17 2006 2007 2008 6 931 7 384 7 841 3 505 3 911 4 297 2 966 3 004 3 051 460 469 493 1 640 1 620 1 620 1 323 1 354 1 414 293 287 310 833 881 932 197 186 172 1 3 330 1 3 390 1 3 420 20 927 22 332 24 209 11 574 12 294 13 711 6 109 6 112 6 224 3 244 3 926 4 274 1 210 1 210 1 200 1 421 1 483 1 546
72. HS 9022 1 6 HS 9021 41 1 HS 9018 54 8 i 9019 0 3 2 2 World Trade Atlas 25 Copyright 2010 JETRO All rights reserved HS 9018 9022 3 4 HS 9021 32 40 1990 Siemens Medical
73. 8 1 3C 2012 1 1 D Authorization Route mith P Radiation Protection Act D HSA A B HSA A HSA Health Products Act Health Products Act Radiation Protection Act 2011 4 Products Act 1 Act 2 2 Radiation Protection Act
74. 2010 JETRO All rights reserved 90221200 ICOMPUTED TOMOGRAPHY APPARATUS BASED ON X RAYS 90221300 OTHER XRAY APPARATUS FOR DENTAL USES 90221400 OTHER XRAY APPARATUS FOR MEDICAL SURGICAL OR VETERINARY USES XRAY APPARATUS FOR THE PHYSICAL INSPECTION OF SOLDER JOINTS ON PCB OR PWB 90221910 ASSEMBLIES 90221990 XRAY APPARATUS FOR OTHER USES ALPHA BETA OR GAMMA RADIATION APPARATUS FOR MEDICAL SURGICAL DENTAL OR 90222100 VETERINARY USES 90222900 ALPHA BETA OR GAMMA RADIATION APPARATUS FOR OTHER USES 90223000 XRAY TUBES PARTS amp ACCESSORIES OF XRAY APPARATUS FOR THE PHYSICAL INSPECTION OF SOLDER OTHER APPARATUS INCL PARTS AND ACCESSORIES BASED ON XRAY ALPHA BETA GAMMA 60 Copyright 2010 JETRO All rights reserved 6 SHARE ER Av FH Alexandra Health Pte Ltd Alexandra Hospital AH 378 Alexandra Road http www alexhosp com sg 400 1938 Singapore 159964 ee KTPH Singapore 768828 hp main home MS EA Singapore 648346 com sg National Healthcare Group NHG members TTSH Singapore 308433 Woodbridge Hospital 10 Buangkok View Singapore 539747 Singapore 308205 National Healthcare Group 6 Commonwealth Lane http www nhgp com sg HN Polyclinics NHGP Level 7 01 02 GMTI Building Singapore 149547 MM ll NT JEDE Singapore 308433 National University Health System National University Hospital 5 Lowe
75. Copyright O 2010 JETRO All rights reserved 6 3 500 3 000 2 500 1 967 1 977 2 000 1 500 100 S 1 000 500 2002 2005 2004 2005 2006 2007 2008 2009 TIT HH Economic Survey of Singapore Agilent defibrillator Baxter Edward Lifesciences Siemens Medical Biosensors International EDB
76. Unity NTUC Healthcare 45 NTUC Fairprice Guardian 120 2 Econ Healthcare Limited http www ntuchealth com sg group unity 22 www guardian com sg 35 Copyright 2010 JETRO All rights reserved 0 1 ws EDB
77. 3 3 1 2002 18 4 2007 31 9 f S 5 1 7 2008 2 2 31 2 558 2009 1 8 31 7 400 S 2009 180 9 55 6 1 1 5 21
78. 585 North Bridge Road 2001 Singapore 188770 63 Copyright O 2010 JETRO All rights reserved ell Singapore 248649 WA Singapore 507709 Connexion Medical centre 1 Farrer Park Station Road http Awww farrerpark com index developed by Singapore and Singapore 217562 html HealthPartners SHP subjected to be completed in Johns Hopkins Singapore 11 Jalan Tan Tock Seng http www imc jhmi edu Lo pee International Medical Centre Singapore 308433 early 2011 oom Anoma ostal etg LL Singapore 574623 hospital org Novena Medical Center Far Novena Medical Center 10 http www novenamedicalcente N A East Organization Sinaran Drive r com Singapore 307506 Singapore 307677 m NN 7 Nr NN Singapore 619771 m 64 Copyright O 2010 JETRO All rights reserved 8 SHE China Healthcare Limited formerly known as Econ Healthcai http www econhealthcare co 1987 m Econ Medicare Centre 06 02 03 04 20 Jalan Afifi six branches of medicare centres and CISCO Centre nurshing homes islandwide Singapore 409179 Sunnyville Home 10 Ama Keng Road Singapore 709828 ECM Medical Group East Coast Medicare Centre East 200 South Bridge Road http www ecmmedicalgroup c 120 1997 Coast Medicare Centre Pte Ltd Singapore 058749 om index htm Irene Nursing Homes http www elderlynursing com 19
79. 2 Inzign Pte Ltd 1 9 8 1 Merlin MD Pte Ltd 2002 Nano Technology Manufacturing Pte Ltd Nextwave Biomedical Pte Ltd BCG Pasture Pharma Pte Ltd 2009 E 2 FDA HE EDB EE L E 6 3
80. 2 483 2 689 2 739 4 469 6 334 6 745 6 984 7 352 7 518 7 713 Yearbook of Statistics Singapore 2010 Long Term Care Healthcare Service 70 64 E 34 E Ci Oy
81. 3 743 S 3 2009 4 16 2006 2007 4E 2008 23 23 22 14 14 14 9 9 8 10 358 10 406 10 312 8 320 8 368 8 319 2 038 2 038 1 993 75 75 78 18 18 18 E ZN Central Provident HI IU
82. 449 484 555 832 865 858 140 134 133 1 3 100 1 3 090 1 3 130 3 33 Copyright O 2010 JETRO All rights reserved 5 2 9 2030 18 2 30 AM 2009 E 81 4 FOS 65 1 22
83. 74 B IVD Bs ET A EKE Bm A ET Bs mt tr Ji nu Lk B a
84. 85 ll KAA KAA uj Singapore 329514 RI RS Singapore 428101 Nightingale Group of Companies http nightingale com sg defaul t htm Nightingale Nursing Centre and Home 106 amp 146 Braddell Road 1980 operating three nursing homes across Singapore 359912 Singapore distributing and renting Greenview Nursing Home 95 Tampines Road 1993 Singapore 535119 65 Copyright O 2010 JETRO All rights reserved Orange Valley Healthcare Pte Ltd also distributing medical needs for elderly Orange Valley Nursing Home MN http www orangevalley sg ERN 1993 operating six branches all over Singapore Others II vv Singapore 534792 Singapore 388352 g therapy html ll Singapore 359566 Singapore 457121 Singapore 297728 oil Singapore 429510 Maritime Medical Centre Pte Ltd 120 Cantonment Road 402 025 Maritime House Singapore 089760 Singapore 387412 cob AA Handicapped Singapore 545610 e ah D Pte Lid Singapore 507871 NEG C wu TT I Singapore 159051 om nursing AAN AH Singapore 425962 ii Singapore 276487 66 Copyright O 2010 JETRO All rights reserved SE R AAA Singapore 786876 m WA EE Diu MAI ee Singapore 319400 misg Windsor Convalescent Home Pte Ltd 369 Pasir Panjang Road Singapore 118706 Winds
85. 9 4 J Radiation Protection Act Health Copyright 2010 JETRO All rights reserved V 232 Health Products Act HSA 2008 11 1 2010 8 6 2010 8 1 2011 C D 7 31 HSA 3 Radiation Protection Act 2011 8 1 H 2011 C D 12 31
86. 95 8056 Contact Person Mr Dave Cheng Email Address certints singnet com sg Date Accredited 26 November 2008 Website http www cert ints com sg home htm Address 151 Chin Swee Road Manhattan House 10 11 Singapore 169876 Telephone 65 6732 7112 Facsimile 65 6732 1362 Contact Person Mr Francis Ho Email Address francisho dascertsg com Date Accredited 08 March 2010 Website http www dascertsg com Address 10 Ubi Crescent 03 66 Ubi Techpark Singapore 408564 Telephone 65 6749 6702 Facsimile 65 6749 6703 Contact Person Mr Vinson Lee Email Address vinson gicg co uk Date Accredited 31 July 2009 Website http www gicg co uk Address 460 Alexandra Road 28 01 02 PSA Building Singapore 119963 Telephone 65 6278 9444 Facsimile 65 6278 7683 Contact Person Mr Foong Wai Kiong Email Address wai kiong foong Ir org Date Accredited 21 April 2010 Website http www Irqa com 57 Copyright O 2010 JETRO All rights reserved SGS International Certification Address 26 Ayer Rajah Crescent 03 07 Singapore 139944 Services Singapore Pte Ltd Telephone 65 6777 2661 Facsimile 65 6778 7780 Contact Person Ms Lee Lai Mei Email Address Lee LaiMei sgs com Date Accredited 14 October 2008 Website http www sgs com T v S d Psb Pte Ltd Address 1 Science Park Drive Singapore 118221 Telephone 65 6885 1662 Facsimile 65 6872 0531 Con
87. Biz Distribution Resource Pte Ltd 20 Danaher subsidiary of Instrumentarium Danaher Dental 39 Copyright 2010 JETRO All rights reserved AB SCIEX Manufacturing KaVo Dental ASIA PACIFIC Pte Ltd Standard Dental Kerr Leica Microsystems SEA Pte Ltd Orthodontic amp Dental Supplies Pte Ltd Ormco Fisher Scientific Pte Ltd Radiometer United Bmec Pte Ltd Radiometer Smitech Asia Pte Ltd SOREDEX N K Luck SybronEndo 21 Olympus Medical Systems Olympus Singapore Pte Ltd 22 Synthes Synthes Singapore Pte Ltd 23 Beckman Coulter Beckman Coulter Singapore Pte Ltd Analytical Technologies Pte Ltd 24 Terumo Medical Terumo Corporation Singapore Branch 25 Alcon AAA Alcon Pte Ltd 27 Biomet NA Asia Implant Support Services Bluestone Corporation Pte Ltd 40 Copyright O 2010 JETRO All rights reserved 28 C R Bard Bard Singapore Pte Ltd Dentsply Dentsply Singapore IDS Dental 29 International Pte Ltd Division Singapore Pte 30 Agfa Healthcare Ltd
88. D Medical Devices using the ASEAN CSDT GN 20 GN 21 G GN 21 G GN 07 R1 Guidance on the Component Elements of a Dear Healthcare Professional Letter Declaration of Conformity Template O Q Z Z e A e 9 D GN 21 G GN 22 GN 23 GN 24 GN 25 Guidance on the Cancellation of Medical Device Listing GN 26 Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named Patient Basis Guidance on the Requirements for Exemption from Product Registration for the Import of GN 27 Unregistered Medical Devices for Supply to a Clinical Laboratory Medical Clinic or Private Hospital licensed under the PHMC Act Guidance on the Requirements for Exemption from Product Registration to Import GN 28 Unregistered Medical Devices solely for Re export or for the Export of Unregistered Medical G Devices GN 29 Guidance on the Requirements for Exemption from Product Registration to Supply Imported G or Manufactured Unregistered Medical Devices for Non Clinical Purpose GN 30 Guidance on the Requirements for Approval to Import Medical Devices on Consignment G Basis Technical Specification Documents TS 01 R2 TS 01 R2 Good Distribution Practice for Medical Devices in Singapore Requirements T Revision 2 July 2010 available for comments Deadline for comments 23 July 2010 TS 01 R1 G Guideline D Draft T Technical specification IGN 20 I
89. GN 21 IGN 21 IGN 21 IGN 22 IGN 23 IGN 24 GN 25 D x 46 Copyright 2010 JETRO All rights reserved 2 1 2 3 peka ajag ia yu BA B 4 1 2 3 o Copyright O 2010 JETRO All rights reserved 47 1 2 5
90. WAA ki ai ba kab Aya 2010 9 Copyright 2010 JETRO All rights reserved Copyright O 2010 JETRO All rights reserved Copyright 2010 JETRO All rights reserved 2 2 du von de ME 3 CAO DE MIWA PCH AR REA Wy ACRE NG CRISE DENIS 3 22 EREADER i MSIWE A dened CENA AA 6 23 SUA AA TA SN aana aaa WAA AAA WALIA KAA tontos gorii 10 2 3 1 10 232 e 12 2 4 SE OSE BL RGR PIER Ua 13 2 4 1 14 AU aan eana Bank Ngak ang a aa Na aa A AG ak an a aaa a naa aia 14 Sr IA Gn a aa NA EA m n 21 3 1 EE e ANE OE T 21 32 RAR a EE 22 335 AA maf QUON EE 23 4
91. dinal Health Singapore 225 Pte Ltd Medtronic 5 Medtronic International Ltd Baxter Baxter Healthcare zi 5 International Asia Pte Ltd Philips Philips Electronics 7 Healthcare Singapore Pte Ltd Tyco Healthcare 8 Covidien NA Pte Ltd Boston Scientific Asia 9 Boston Scientific Pacific Pte Ltd 38 Copyright O 2010 JETRO All rights reserved Abbott Laboratories S Pte Ltd 10 Abbott Labs Nutritionals and Pharmaceuticals Abbott Laboratories S Pte Ltd Diagnostics Becton Dickinson Becton 11 Medical Singapore Dickinson Pte Ltd Styker South Asia 12 Stryker Singapore B Braun Singapore 13 B Braun Pte Ltd St Jude Medical S 14 St Jude Medical Pte Ltd 3M Singapore Pte Ltd 15 3M Healthcare 3M Technologies Singapore Pte Ltd 3M Innovation Singapore Pte Ltd Zimmer 16 Zimmer Pte Ltd Holdings Toshiba Medical 17 Toshiba Gold Lite Pte Ltd Systems Asia Pte Ltd Smith amp Nephew Pte 18 Smith amp Nephew E Ltd PL Asia Pacific 19 Hospira NA Singapore Pte Ltd AB SCIEX Health
92. e Road 28 00 Raffles City Tower 44 Copyright O 2010 JETRO All rights reserved Singapore 179101 Tel 65 6832 6832 Fax 65 6832 6565 Email clientservices edb gov sg 45 Copyright O 2010 JETRO All rights reserved 1 HSA Guidance Ode Title C GN 01 R1 Guidance on the Application of Good Distribution Practice for Medical Devices in Singapore Declaration for Exemption from GDPMDS Template 02 Guidance on Licensing for Manufacturers Importers and Wholesalers of Medical Devices GN 03 example SMF Example for GN 03 Guidance on Preparation of a Site Master File for Licensing 03 04 GN 05 R1 Guidance on Reporting of Adverse Events for Medical Devices GN 06 R1 Guidance on Distribution Records for Medical Devices GN 07 R1 Guidance on Complaint Handling of Medical Devices OJO Z ZIZ o olo e IN JJ D IO GN 08 Guidance on Medical Devices Advertisements and Sales Promotion of Medical Devices GN 10 R1 Guidance on Medical Device Field Safety Corrective Action GN 11 Guidance on the Declaration of Conformit GN 12 GN 13 R1 GN 14 R1 GN 15 GN 15 R3 GN 16 1 GN 17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT 18 Annex 2 for GN17 and GN18 List of Configurations of Medical Devices to be Registered GN 18 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic IV
93. formation Divisions Blood Services Group Blood Supply Patient Services Divisions Forensic Medicine Forensic Science Applied Sciences Group ae amp Toxicology Pharmaceutical Food Safety Chemical Metrology HSA Academy HSA 7 Copyright 2010 JETRO All rights reserved 2 Health Products Regulations Group Health Products Regulation Group Therapeutic Products Division Medical Device Branch Licensing amp Surveillance Unit HH Medical Device Regulatory Framework Implementation Update October 2008 HSA T L N Health Products Act HSA Regulatory Guidance Health Products Act 2008 11 Health Products Act 2002 Voluntary Product Registration Scheme VPRS VPRS Health Products Act 2007 2
94. kway Health Raffles Medical Pacific Holdings e Parkway Health 197 1 2 484 S 2009 9 7 820 S
95. or Nursing Home Pte Ltd 2 4 Jalan Ulu Siglap Singapore 457121 All Saints Home The Tampines Homd 11 Tampines Street 44 http Awww allsaintshome org s 179 2001 Singapore 529123 0 All Saints Home The Hougang Home 5 Poh Huat Road http Awww allsaintshome org s partially subsidized since January 144 1986 Singapore 546703 0 2010 Apex Harmony Lodge 10 Pasir Ris Walk http www apexharmony org s n Sincapore 518240 Jindek ohi 1999 specialized for dementia patients The Lions Home for the Elders 41 Toa Payoh Rise 487 Bedok South Avenue 2 Peacehaven Nursing Home http www salvationarmy org s mm www smm singapore nsf 9 Upper Changi Road North VW Singapore 507706 sublinks 01F5FF03C34EED77 201 WANG GD TE SAN AAN Army 802571260011BE69 openDoc ument Ren Ci Nursing Home 50 Jalan Tan Tock Seng http www renci org sg Home f 210 1999 Singapore 308438 aspx azi UA mm AA Singapore 569766 php Singapore 547530 Kwong Wai Shiu Hospital KWSH 705 Serangoon Road http www kwsh org sg index h 1910 Singapore 328127 tm 67 Copyright 2010 JETRO All rights reserved SEE Singapore 329562 amp 154 chronic AT Singapore 529895 St Luke s Hospital 2 Bukit Batok Street 11 http www slh org sg Singapore 659674 RENE Bright Vision Hospital 5 Lorong Napiri http www bvh org sg Le Singapore 547530 St L
96. r Kent Ridge Road http www nuh com sg 1985 NUH Singapore 119074 61 Copyright 2010 JETRO All rights reserved Singapore Health Services SingHealth members CGH Singapore 529889 Hospital Singapore 229899 ome aspx Singapore General Hospital Outram Road http www sgh com sg Pages d 1600 1821 SGH Singapore 169608 efault aspx Tower 5 15 10 g Pages Home aspx Singapore 150167 Singapore NCCS Singapore 169610 Singapore 168938 National Heart Centre NHC 17 Third Hospital Avenue http Awww nhcs com sg Pages 185 1994 Mistri Wing Home aspx Singapore 168752 Singaporeans eT Institute NNI Singapore 308433 Singapore 168751 home aspx Jurong Health Services Jurong General Centre Jurong Lakeside District http Www juronghealth com sg scheduled to be open in 2014 Singapore 62 Copyright O 2010 JETRO All rights reserved 7 SHARE ER Parkway Holdings Ltd Parkway Group Healthcare http www parkwayhealth com i ndex asp aaa Singapore 258500 Singapore 22851 0 formerly known as East Shore Singapore 427990 Hospital Singapore sg second quarter of 2012 Pacific Healthcare Group http www ii adi co Adam Road Medical Centre 559 Bukit Timah Road 401 02 http www TETS CO 1968 King s Arcade Singapore 269695 m arh REN C ANN Singapore 238859 Em Adam Road 2011 Raffles Medical Group http Www rafflesmedicalgrouDp com Raffles Hospital
97. tact Person Mr Wu Tek Ming Email Address tek ming wu tuv sud psb sg Date Accredited 27 April 2009 Website http www tuv sud psb com 58 Copyright O 2010 JETRO All rights reserved BAS HS HS Code 9018 30181100 30181200 30181300 30181400 30181900 30182000 30183110 30183190 90183200 90183910 90183920 90183990 90184100 90184900 90185000 90189020 90189030 ELECTRONIC INSTRUMENTS amp APPLIANCES USED IN MEDICAL SURGICAL VETERINARY NON ELECTRONIC MEDICAL SURGICAL OR VETERINARY INSTRUMENTS amp APPLIANCES NES 90189090 OR INCLUDED ELECTRONIC MECHANO THERAPY APPLIANCES MASSAGE PSYCHOLOGICAL APTITUDE 90191010 NON ELECTRONIC MECHANO THERAPY APPLIANCES MASSAGE amp PHYSCHOLOGICAL 90191090 OZONE OXYGEN amp AEROSOL THERAPY amp ARTIFICIAL RESPIRATION OR OTHER 90192000 AT OTHER BREATHING APPLIANCES amp GAS MASKS EXCL PROTECTIVE MASKS WITH NO 90200000 Ka as AA a aa UN 90211000 90212100 90212900 90213100 90213900 90214000 HEARING AIDS EXCL PARTS amp ACCESSORIES 90215000 PACEMAKERS FOR STIMULATING HEART MUSCLES EXCL PARTS amp ACCESSORIES OTHER APPLIANCES WORN CARRIED OR IMPLANTED IN THE BODY FOR COMPENSATING 90219000 DEFECT OR DISABILITY 59 Copyright
98. titute of Mental Health National Skin Centre NHG Polyclinics The Eye Institute SingHealth Changi General Hospital KK Women s and Children s Hospital Singapore General Hospital Polyclinics SingHealth National Cancer Centre Singapore National Dental Centre National Heart Centre National Neuroscience Institute Singapore National Eye Centre Alexandra Health Khoo Teck Puat Hospital Jurong Medical Centre Alexandra Hospital Jurong General Hospital 2014 NUHS National University Hospital 30 Copyright O 2010 JETRO All rights reserved 7 2 Par
99. uke s Hospital 2 Bukit Batok Street 11 http www slh org sg 85 1996 dl Singapore 659674 1 1 Ren Ci Community Hospital 71 Irrawaddy Road http Awww renci org sg 123 community 2008 Singapore 329562 amp 154 chronic Ren Ci Hospital amp Medicare Centre Blk 9 Level 1 10 Buangkok http www renci org sg 1994 Buangkok View Singapore 539747 68 Copyright O 2010 JETRO All rights reserved
Download Pdf Manuals
Related Search
Related Contents
Samsung DIGIMAX 4500 SUPER User Manual MSDS - シグマアルドリッチジャパン 取扱説明書(1633KB) 鑑目立説明 書) - サンライテック USER GUIDE FOR THE RETURN OF EMPLOYMENT Manuel FST 200 Sitecom Wireless Network Patch Antenna 8dBi User`s Guide - Pro-Lite TORPILLE-TORPILLEUR Torpilleurs sous Copyright © All rights reserved.
Failed to retrieve file