| 國別 | 文件類別 | 文件名稱 |
| ROC | 法規 |
藥事法(2006.05.30)
|
| ROC | 法規 |
藥事法施行細則(2005.02.16)
|
| ROC | 法規 |
藥物製造工廠設廠標準(2004.11.26)
|
| ROC | 法規 |
藥物製造業者檢查辦法(2002.02.20)
|
| ROC | 法規 |
醫療器材查驗登記審查準則(2006.04.12)
|
| ROC | 法規 |
體外診斷試劑查驗登記須知(2003.07.31)
|
| ROC | 法規 |
嚴重藥物不良反應通報辦法(2004.08.31)
|
| ROC | 法規 |
藥物回收作業實施要點(2000.05.16)
|
| ROC | 表單 |
公告國產製造廠GMP申請書格式(2007.06.06)
|
| ROC | 表單 |
公告輸入製造廠醫療器材QSD申請書格式(2007.06.06)
|
| ROC | 表單 |
醫療器材查驗登記申請書(正本)(2005.10.05)
|
| ROC | 表單 |
醫療器材查驗登記申請書(副本)(2005.10.05)
|
| ROC | 表單 |
第一等級醫療器材切結書(2005.10.05)
|
| PRC | 法規 |
医疗器械临床试验规定(局令第5號；2004.01.17)
|
| PRC | 法規 |
国家食品药品监督管理局关于涉及行政审批的行政规章修改、废止、保留的决定(局令第8號；2004.06.30)
|
| PRC | 法規 |
医疗器械说明书、标签和包装标识管理规定(局令第10號；2004.07.08)
|
| PRC | 法規 |
医疗器械生产监督管理办法(局令第12號；2004.07.20)
|
| PRC | 法規 |
医疗器械经营企业许可证管理办法(局令第15號；2004.08.09)
|
| PRC | 法規 |
医疗器械注册管理办法(局令第16號；2004,08,09)
|
| PRC | 法規 |
医疗器械分类规则局令第15號；2000,04,05)
|
| PRC | 法規 |
医疗器械新产品审批规定（试行）(局令第17號；2000,04,10)
|
| PRC | 法規 |
医疗器械生产企业质量体系考核办法(局令第22號；2000,05,22)
|
| PRC | 法規 |
一次性使用无菌医疗器械监督管理办法(局令第24號；000,10,13)
|
| PRC | 法規 |
医疗器械标准管理办法（试行）(局令第31號；2002,01,04)
|
| PRC | 法規 |
医疗器械监督管理条例(务院令第276号；2000.01.04)
|
| Japan | 法規 |
薬事法(2006.06.21)
|
| Japan | 法規 |
薬事法施行規則(2009.10.16)
|
| Japan | 法規 |
医療機器及び体外診断用医薬品の製造管理及び品質管理の基準準(2004.12.17)
|
| Japan | 指引 |
医療機器の製造販売手順について(2006.03.16)
|
| Japan | 指引 |
体外診断用医薬品の製造販売手順について(2006.03.16)
|
| Japan | 指引 |
外国製造業者認定申請の作成例(2009.03.19)
|
| US | 法規 |
Federal Food, Drug, and Cosmetic Act(2004.12.31)
|
| US | 法規 |
21 CFR PART 820 Quality System Regulation(2009.04.01)
|
| US | 法規 |
21 CFR 58 - Good Laboratory Practice Regulations(2009.04.01)
|
| US | 指引 |
Guidance for Industry, FDA, and Foreign Governments FY 2010 Medical Device User Fee Small Business Qualification and Certification(2009.08.03)
|
| US | 指引 |
Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff(2003.02.03)
|
| US | 指引 |
Deciding When to Submit a 510(k) for a Change to an Existing Device(1997.01.10)
|
| US | 指引 |
Guidance for Industry and FDA Staff - Format for Traditional and Abbreviated 510(k)s(2005.08.12)
|
| US | 指引 |
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance(1998.03.20)
|
| US | 指引 |
Guidance for Industry and FDA Premarket and Design Control Reviewers - Medical Device Use-Safety Incorporating Human Factors Engineering into Risk Management(2000.07.18)
|
| US | 指引 |
Guidance for Industry - Acceptance of Foreign Clinical Studies(2001.03)
|
| US | 指引 |
Design Control Guidance For Medical Device Manufacturers(1997.03.11)
|
| US | 指引 |
An Introduction to Human Factors in Medical devices(1996.12)
|
| US | 指引 |
Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions(2007.10.25)
|
| US | 指引 |
Guidance for Industry and FDA Staff - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests(2007.03.13)
|
| US | 指引 |
Guidance for Industry-In Vitro Diagnostic Glucose Test System(1998.07.06)
|
| US | 指引 |
Points To Consider For Collection Of Data In Support Of In-Vitro Device Submissions For 510(K) Clearance(1997.02.27)
|
| US | 指引 |
Draft Guidance for Industry and FDA Staff - Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile(Draft Guidance)(2008.12.12)
|
| US | 指引 |
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA(2002.030)
|
| US | 指引 |
Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1 Evaluation and Testing(1995.05.01)
|
| US | 指引 |
Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices (Draft Guidance)(2007.01.03)
|
| US | 指引 |
General Principles of Software Validation; Final Guidance for Industry and FDA Staff(2002.01.11)
|
| US | 指引 |
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software(2005.01.14)
|
| US | 指引 |
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices(2005.05.11)
|
| US | 指引 |
Guidance for Industry, FDA Reviewers and Compliance on Off The-Shelf Software Use in Medical Devices(1999.09.09)
|
| EU | 法規 |
Directive 93/42/EEC(1993.06.14)
|
| EU | 法規 |
Directive 90/385/EEC(1990.06.20)
|
| EU | 法規 |
Directive 98/79/EEC(119.10.27)
|
| GHTF | 指引 |
SG1-N11(2008.05.29)
|
| GHTF | 指引 |
SG1-N41R9(2005.07.21)
|
| GHTF | 指引 |
SG3-N15R8(2005.07.21)
|
| GHTF | 指引 |
SG4-N28R4(2008.10.24)
|
| GHTF | 指引 |
SG4-N30R20(2006.08.31)
|
| GHTF | 指引 |
SG4-N33R16(2007.11.19)
|
| GHTF | 指引 |
SG4 (00) 3(2000.10.30)
|