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Taiwan’s MOHW Issues Draft Revision of UDI Requirements; Draft Amendment of the Charge Standards of Administrative Fees

Taiwan

December 2, 2022

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.

Draft amendment of the charge standards of administrative fees for medical devices

The MOHW has issued a notice (link in Chinese) to open the public consultation for the draft amendment of the Charge Standards of Administrative Fees for Medical Devices.

Notably, the following are proposed to be added:

  • A fee of NT$10,000 for the good distribution system inspection or its follow-up inspection for each additional warehouse
  • Fees for application and modification of the medical device dealer license