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Latest Status of the Medical Devices Regulation in Taiwan

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2022-11-30
  • Last Updated:2022-11-30

    The Medical Devices Act governing medical devices officially took effect on May 1, 2021.  This independent law helps to build a product lifecycle management system for medical devices.  In fulfillment of its mandate under the Act, TFDA continues to evaluate the medical devices regulation to make suitable revisions and adjustments in a timely manner.

    In 2022, the following regulations have been announced or amended according to Article 19, Article 33, and Article 52 of the Medical Devices Act, respectively:

1. TFDA announced that starting from June 1, 2022, license holders of Class III medical devices are required to upload UDI and corresponding product information to the UDI Database (UDID).  Medical device manufacturers are also required to place UDI on the product label.  In addition, starting from June 1, 2023, Class II medical devices are required to meet relevant regulations of UDI.

2. Taking technology development into account and making it easier for consumers to obtain instructions, TFDA announced that 38 types of medical devices can have paper instructions replaced with electronic ones since March 8, 2022.

3. To ensure the quality of COVID-19 antigen home/self-test in Taiwan, TFDA amended the Regulations Governing Border Inspection and Examination of Imported Medical Devices.  COVID-19 antigen home/self-test has therefore been subject to the provisions governing medical device items that require border inspection by the central competent authority since July 8, 2022.