China | Draft of the Enforcement Rules of Medical Devices Act (8 page(s), in English; 9 page(s), in Chinese)

Title of document
Draft of the Enforcement Rules of Medical Devices Act (8 page(s), in English; 9 page(s), in Chinese)

Description
With a view to implementing the Medical Devices Act, which was promulgated on 15 January 2020, the Ministry of Health and Welfare is proposing to draft the ''Enforcement Rules of Medical Device Act'' to provide further details. The provisions of the draft enforcement rules include: terms, registration of medical device firms, regulations on labeling, regulations on approval of medical device advertisements and rewards for reporting violations, etc.

Notifying member: Chinese Taipei

Notification: G/TBT/N/TPKM/449

Objective tag
Consumer information, labelling; Protection of human health or safety

Documents

• 21_0161_00_et.pdf
• 21_0161_00_x.pdf

Agency responsible
Food and Drug Administration Ministry of Health and Welfare No.161-2, Kunyang St., Nangang Dist. Taipei City 115209, Taiwan Tel: +(886-2) 2787-8078 Email: menghan1215@fda.gov.tw

Timing:

• Submission: 04/01/2021
• Reception: 04/01/2021
• Distribution: 05/01/2021
• Final date for comments: 06/03/2021
• Proposed date of adoption: N/A