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 1 General Provisions

Article 1

The Regulations are stipulated in accordance with Article 29 of the Medical Devices Act (hereinafter referred to as "the Act").

Article 2

The terms used in the Regulations are defined as follows:
1. Manufacture and free sale certificate of the country of origin: refers to a certification document issued by the highest health authority or agency of the country where an imported medical device is manufactured that verifies the medical device is manufactured and sold freely in that country.
2. Foreign original manufacturer authorization letter: refers to an authorized agent letter issued by the foreign original manufacturer of an imported medical device.
3. In Vitro Diagnostic Device (IVD): refers to a reagent, instrument, software, or system used to collect, prepare, or test specimens from human body in order to diagnose disease, determine the state of health or other conditions.
4. Predicate device: refers to a medical device that has obtained domestic license or listing and meets one of the following conditions:
(1) It has the same intended use and technical characteristics as the proposed medical device applying for license or listing.
(2) It is a medical device other than the one referred to in the preceding subparagraph, has the same intended use as the proposed medical device applying for license or listing, and has different technical characteristics but which do not affect product safety and efficacy.