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

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Chapter Law Content

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

Chapter 6 Supplementary Provisions

Article 24

If the documents and information submitted with an application filed in accordance with the Regulations are not in traditional Chinese or English, a traditional Chinese or English translation shall be provided.

Article 25

If the application involves contract manufacturer, approval certificate obtained in accordance with the Regulations Governing Contract Manufacturing of Medical Devices shall be submitted by the applicant.

Article 26

The Regulations shall be implemented on May 1, 2021.
Amendments to the Regulations shall be implemented on the date of promulgation.