Taiwan - Top Medical Device Alerts

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.
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.
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
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.
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.
How can RegDesk help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.