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Medical Devices

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration

【Update Date：2023-11-27】unit：醫療器材及化粧品組

【Announced Date：2021-04-29】

【Amended Date：2023-11-27】

Chapter 1 General Provisions
Chapter 2 Registration and Market Approval of Medical Device and Issuance of License
Chapter 3 Change, Re-issuance, or Replacement of License
Chapter 4 License Extension
Chapter 5 Listing and Annual Declaration
Chapter 6 Supplementary Provisions

Files

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration(PDF)
Appendix 1： Documents and information that shall be submitted for an application of registration and market approval to manufacture or import Class 1 medical devices
Appendix 2： Documents and information that shall be submitted for an application of registration and market approval to manufacture or import Class 2 or Class 3 medical devices
Appendix 3：“Applicable Product Items for Class 2 Medical Device Product Comparison and Preclinical Test Data Conformity Statement”mentioned in Section 7 of the Instructions in Appendix 2
Appendix 4：Documents and information that shall be submitted for an application of change， re-issuance， or replacement of medical device license
Appendix 5：Documents and information that shall be uploaded for an application for a listing to manufacture or import Class 1 medical devices

Links

Law&Regulations Database of The Republic of China