Taiwan - Top Medical Device Alerts

04/11/2023

Announcement 1121602624 is published Announcement 1121602624 is published. In the announcement, recognized standards of this year are listed, abolished standards of previous years are also attached.

03/29/2023

Announcement 1121601600 is published Announcement 1121601600 is published, it is about medical device applicable for electronic user manual, and additional requirement for label and package.

02/13/2023

Announcement 1121600286 is published. Announcement 1121600286(UDI requirement of medical device labelling) is published according to article 33, item 1, clause 10 of medical device management law. *UDI: Unique Device Identification

01/18/2023

Announcement 1111611744 is published Announcement 1111611744 is published, and become effective, announcement 1101603571 is abolished at the same time. According to announcement, products in the list should be inspected during medical device registration and change.

01/12/2023

Announcement 1111612882, two technical specifications were published. Announcement 1111612882, two technical specifications were published, including novel coronavirus nucleic acid detection reagent specification and novel coronavirus antigen detection reagent specification.

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