Medical devices; Medical equipment (ICS 11.040)

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

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.