1. 藥事法(95.05.30修) 

2. 藥事法施行細則(94.02.16修) 

3. 藥品查驗登記審查準則(97.05.13修)

4. 中藥新藥查驗登記須知(88.10.20修)

5. 醫療器材查驗登記審查準則(95.04.12修)

6. 體外診斷試劑查驗登記須知(92.07.31公告)

7. 中華人民共和國藥品管理法(2001.12.28發佈)

8. 中華人民共和國藥品管理法實施條例(2002.08.15發佈)

9. 醫療器械監督管理條例(2000.01.04發佈)

1. GHTF SG1/N45：Principles of In Vitro Diagnostic(IVD) Medical Devices Classification(2008.02.19)

2. GHTF SG1/N15：Principles of Medical Devices Classification(2006.06.27)

3. GHTF SG1/N41R9：Essential Principles of Safety and Performance of Medical Devices(2005.05.20)

4. GHTF SG1/N11：Summary Technical Documentation for Demonstrating conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)(2008.02.21)

5. GHTF SG2/N6R3：Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia＆Japan(2002.05.21)

6. GHTF SG5/N2R8：Clinical Evaluation(2007.05)

7. GHTF SG5/N1R8：Clinical Evidence-Key Definitions and Concepts(2007.05)

8. FDA Guidance：Guidance for Industry and FDA Staff；Neonatal and Neonatal Transport Incubator-Premarket Notifications(1998.09.18)

9. FDA Guidance：Guidance for Industry and FDA Reviews/Staff；Class II Special Controls Guidance Document：Bone Sonometers (2008.07.17)

10.FDA Guidance：Guidance for Industry and FDA Reviews/Staff；Guidance Document for Powered Suction Pump 510(k)s (1998.09.30)

1. 藥品臨床試驗申請書(91.04.17更新)

2. 體外診斷試劑查驗登記查檢表(92.09.10更新)