Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the charge standards of administrative fees for medical devices

Taiwan’s Ministry of Health and Welfare (MOHW) has issued Announcement No. 1111610130 and Announcement No. 1111606650 (links in Chinese) to commence the public consultations for the abolition of the Requirements for Indicating the Unique Device Identifier on Medical Device Labels (MOHW Announcement No. 1101602479 dated April 6, 2021) and the new draft Requirements for Indicating the Unique Device Identifier on Medical Device Labels, respectively.

Notably, the draft includes a new Annex III, which specifies certain Class II medical devices that would be exempt from identifying the Production Identification (PI) code.

Further details are provided in the attachments to the Announcements. The MOHW will accept feedback until January 3, 2023…