General Information for the Draft Amendment of Annex I to Article 3 and Annex II to Article 4 of the "Regulations for Governing the Management of Medical Device" (18 pages, in English; 14 pages, in Chinese)

To ensure the safety of public health, the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare (MOHW) intends to amend the current "Regulations for Governing the Management of Medical Device". By this amendment, Annex I and Annex II of "Regulations for Governing the Management of Medical Device" are modified to represent the state of the art of medical device regulation.