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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US指引 Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions(2007.10.25)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)