Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration - Legislative History - Laws & Regulations Database of The Republic of China (Taiwan)

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Legislative History

Title：	Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration CH
Announced Date：	2021-04-29
Amended Date：	2023-11-27
Category：	Ministry of Health and Welfare（衛生福利部）
Attachment：	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.pdf 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.pdf 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.pdf Appendix 4：Documents and information that shall be submitted for an application of change, re-issuance, or replacement of medical device license.pdf Appendix 5：Documents and information that shall be uploaded for an application for a listing to manufacture or import Class 1 medical devices.pdf

1.Full text including 26 articles adopted and promulgated by the Ministry of Health and Welfare per Order Bu-Shou-Shi-Zi No. 1101603144 on April 29, 2021. These Regulations shall enter into force take effect on May 1, 2021.
2.Article 3, 7, 13, 14, 20, 21, 26, Appendix 1 of Article 5, Appendices 2 and 3 of Article 6 amended, and Article 13-1 added by the Ministry of Health and Welfare per Order Bu-Shou-Shi-Zi No. 1121610033 on November 27, 2023.