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1 / ( ). 1.. - (Department of Health). - . (DOH) .. (MOEA) (BOFT). (import license) DOH . (pre-marketing registration approval) . - DOH (the Department of Health) . BOPA (Bureau of Pharmaceutical Affairs) . - . - DOH . , .. - .. DOH . USFDA 21(CFR) I, II, III .. HIV-1/2, HTLV-I/II, B , -A, -B . (IVD) 2002 12 . IVD . IVD . - 1 - - (Pharmaceutical Affairs Law) , (pre-market approval) .. DOH . (2006 4 12 ) , . 40 . 2.. , .. (DOH) .. (MOEA) (BOFT) (import license) DOH . (pre-marketing registration approval) . 3.. (Registration Certificate) . (Pharmaceutical Affairs Law) . , (pre-market approval) .. (case-by-case decision) . , 6 .. DOH (2006 4 12 ) , 40 . - 2.

2 DOH 2000 6 30 .. DOH USFDA . 21(CFR) I, II, III . HIV-1/2, HTLV-I/II, B . , -A, -B (IVD) 2002 12 .. IVD IVD . , . , .. Level I. Level II .. Level III. FDA 3 , 16.. No.. Clinical chemistry and clinical toxicology 1. devices 2 Hematology and pathology devices 3 Immunology and microbiology devices 4 Anesthesiology devices 5 Cardiovascular devices 6 Dental devices 7 Ear, Nose, and Throat devices 8 - Gastroenterology-Urology devices - 3 - 9 General and Plastic Surgery devices 10 General hospital and personal use devices 11 Neurological devices 12 Obstetrical and Gynecological devices 13 Ophthamlic devices 14 Orthopedic devices 15 Physical medicine devices 16 Radiology devices.

3 / DOH , DOH 30 .. GMP . (GMP) 1999 2 , 2004 2 10 .. GMP .. 1998 .. FDA .. , . (QSD: Quality System Documentation) . GMP 20 . (ISO13485) . 1). I, II, III GMP .. I . DOH USFDA 1998 1 USFDA . (EIR) .. DOH .. - FDA (EIR). 1) - 4 - - . - ISO 13485 ( EN46001 ). DOH 2004 11 4 , 6 , . TUV Product Service, (NSAI), G-MED, Medical Device Certification (MDC), (BSIPS), TUV Rheinland Product Safety EU .. QSD(Quality System Documentation) .. GMP ISO 13485 . (GHTF) .. , . 2004 6 15 . DOH . , , .. DOH . IEC 6060-1, 1998 Medical Electrical Equipment Part 1: DOH-00001 1, 1991, General Requirement for Safety and Amendment 1, 2, 1995 Amendment 2. Medical Electrical Equipment - Part 1: DOH-00002 IEC 6060-1-1:2000 General Requirements for Safety; Safety Requirements for Medical Electrical Systems Medical Electrical Equipment - Part 1, DOH-00003 IEC 6060-1-2:2001 General Requirements for Safety; electromagnetic Compatibility - Requirements and Tests Medical Electrical Equipment - Part 1: DOH-00004 IEC 6060-1-3:1994 General Requirements for Safety: General Requirements for Radiation Protection in Diagnostic X-ray Equipment Medical Electrical Equipment - Part 1: DOH-00005 IEC 6060-1-4:2000 General Requirements for Safety.

4 4 Collateral Standard: Programmable Electrical Medical Systems - 5 - Sterilization of Health Care Products - DOH-00006 ISO 11134:1994 Requirements for Validation and Routine Control -Industrial Moist Heat Sterilization DOH-00007 ISO 11135:1994 Medical Devices _ Validation and Routine Control of Ethylene Oxide Sterilization Sterilization of Health Care Products _. DOH-00008 ISO 11137:1995 Requirements for Validation and Routine Control 1, 2001 -Radiation Sterilization and Amendment 1. DOH-00009 ISO 10993-1:2003 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing DOH-00010 ISO 10993-5:1999 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity DOH-00011 ISO 10993-6:1994 Biological Evaluation of Medical Devices - Part 6: Test for Local Effects After Implantation DOH-00012 ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals Biological Evaluation of Medical Devices - DOH-00013 ISO 10993-10:2002 Part 10: Tests for Irritation and Sensitization - Maximization Sensitization Test DOH-00014 ISO 10993-11.

5 1993 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity DOH-00015 ISO 10993-12:2000 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials 4.. DOH (the Department of Health) . DOH IVD GMP/QSD .. (The Industrial Technical Research Institute -ITRI), (The Metal Industry Research and Development - 6 - Center), (The Electronics Testing Center), (The Pharmaceutical Industry Development Center) . DOH (Bureau of Food & Drug Analysis-BFDA) Class II Class III . , , . , , . 6 .. - . - . - . - . - . - .. BOPA (Bureau of Pharmaceutical Affairs) . , DOH (Bureau of Pharmaceutical Affairs -BOPA) .. BOPA.

6 (The National Bureau of Standards -NBS) . (The Nuclear Science Council -NSC) . (The National Health Administration -NHA) .. - . - . - . - . - . - , , , , , .. - 7 - . Contact The Department of Health Bureau of Pharmaceutical Affairs No. 100 Ai Kuo E. Raod, Taipei, Taiwan - Homepage: - Tel: 886-2-2321-0151. - Fax: 886-2-2397-1548. 5.. DOH , .. , .. DOH , 2001 20,560 .. Flow Chart - 8 - .. (1) . (DOH) .. , , . , , , .. , , .. (2) .. 10 .. - 9 - (3) .. - , .. - . , . - , , .. - , , .. - , , .. / .. (BOPA) . (1) Level 1 (Market Approval) . - Level 1 . - . (2) Level 2 Level 3 . - 1 . - , 3 . - . , ( ), .. - . , .. - 10 - (TECRO) . - (foreign original manufacture).

7 - , , , . 2 . - , , , , , 2 .. - GMP . - . - . - 2 .. , , . (3) . Level II USFDA CFG( ) EC( ) . , , / , , , .. 1 Level II ( ) .. Level II III . (4) In Vitro Diagnostics(Test Kits). 5% 10% .. ( , , ABO . ) , .. - . - . - , , ( ), , . - 11 - , , , .. - . - .. - , . - , . - . - , . - . - ( ).. - (In-house panels preparation procedures). - . - . - . - . (5) .. 2 . 1 .. 1 .. , . , , , . , .. - 12 - .. 6.. Level 1 Level 1 .. (1) . - . - . - . (2) . - . - . - . - . - . (3) , , . - . - . - , . - 13 - - , , . - , 2 . (4) . - . - . - . - , 2 . - , , , . 2 . - , , , , , 2 . - . - . - 2 . (5) . - . - . - . (6) . - . - . - . - , 2 . - , , , . 2 . - , , , , , 2.

8 - . - . - 14 - - . (7) . - . - . - . - . - . - . - GMP . (4) . (8) . - . - . - . - . - . - . - GMP . (4) . 7.. 3 .. 6 . - 15 - .. - , , ( ) .. - . - . - . - GMP . GMP .. GMP .. - 16.