Overviews of Medical Devices Act
The Food and Drug Administration under the Ministry of Health and Welfare (hereinafter referred to as the “FDA”) has been planning the structure of the “Medical Devices Act” and has conducted an evaluation of the legal system since 2014. The draft provisions were publicly announced on December 5, 2016, passed on the third reading on December 13, 2019, and announced by the President on January 15, 2020. This article will explain the promotion process, legislative benefits, regulatory framework and focuses of the Medical Devices Act, and introduce the highlights of the new system built upon this Act. The formulation and implementation of this Act will protect consumer rights, reduce barriers of international regulations, and enhance the international competitiveness of the medical device industry, thus creating a win-win situation for the medical device industry in Taiwan.