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TFDA Food and Drug Administration (Taiwan Certification)
Language:Chinese(Traditional)

The regulatory system for the safety and quality of food, drug, medical device, and cosmetics is critical to the public health. As these products are intimately involved in people’s daily life and health as well as medical welfare, the Department of Health had been striving to facilitate organizational reform by focusing on consumer health in terms of food and drug safety. Consolidation of the Bureau of Food Safety, the Bureau of Pharmaceutical Affairs, the Bureau of Food and Drug Analysis and the Bureau of Controlled Drugs into the Taiwan Food and Drug Administration (TFDA) was completed on January 1st, 2010, following the promulgation of the TFDA Organization Act on June 3rd, 2009.
Article 1 | The present regulations are in accordance to the Article 13, Paragraph 2 of the Pharmaceutical Affairs Act. |
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Article 2 | Medical device are classified into the following classes according to their level of risks:
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Article 3 | In accordance to the function, intended use, instruction for use and working principle, medical devices are classified into the following categories:
The classification of medical devices into the above categories is as Annex I. |
Article 4 | The manufacturing of medical device shall comply with Chapter 4, Good Manufacturing Practices (GMP) for Medical Device of the Standards for the Establishment of Pharmaceutical Factory. For this part, except for items that required sterilization, medical devices on Annex II are exempted from the above requirement. |
Article 5 | Medical devices that require clinical trial to be performed domestically are stated in Annex III. |
Article 6 | Pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for inquiry of the classification of a medical device and its regulatory control with the provision of the following:
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Article 7 | (deleted) |
Article 8 | These Regulations shall enter into force as of the date of promulgation. |