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

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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

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