Taiwan’s FDA Completes Draft of Medical Devices Act

The Taiwan Food and Drug Administration (TFDA) has completed a draft of the new Medical Devices Act. The new act will effectively separate the management of medical devices from the existing Pharmaceutical Affairs Act.

The draft proposal of the Medical Devices Act has been sent to the WTO for feedback, and should reach the Executive Yuan for review at the end of 2017.

According to a TFDA news update on July 7, 2017, the Medical Devices Act will result in changes to the medical device classification system and regulation of medical manufacturers through:

  • Strengthening the classification system of medical devices
  • Classifying medical device manufacturers according to manufacturing phases
    • Classifying registered legal entities that design and bring medical devices to market as manufacturers
    • Classifying legal entities that rent, service, or repair as medical device dealers
  • Requiring supply-chain management and Good Distribution Practice (GDP) for medical devices