Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration CH · Ministry of Health and Welfare（衛生福利部）.

After approval of the application set forth in Paragraph 1, the license is issued with a new number. Chapter 5 Listing and Annual Declaration. Article 20.

14 окт. 2021 г. · Enforcement Rules of Medical Devices Act. • Regulations Governing Issuance of Medical Device. License, Listing and Annual Declaration.

15 мар. 2024 г. · Moreover, according to the amended “Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration” in 2023, if the ...

◇ A1: According to Article 6 and Section 4 in Appendix 2 of Regulations. Governing Issuance of Medical Device License Listing and Annual Declaration,.

A medical device manufacture or import license is valid for a period no longer than five years starting from the date of issue. Where it is necessary to ...

8 янв. 2024 г. · On November 27, 2023, Taiwan issued an amendment to the – Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration.

The registration of imported medical devices in Taiwan is a two-stage process, which is highly regulated by the Taiwan Food and Drug Administration (TFDA).

STEP 1 | Appoint a In-country Regulatory Representative. A foreign manufacturer must appoint an in-country representative to apply for registration in Taiwan.

22 сент. 2021 г. · The issuance of licenses for medical devices is flexible regarding its term of validity. The maximum term of validity is 5 years, and extensions ...