Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration was established in 2010 to oversees food, drug and medical device safety and quality. The TFDA deal with the risk assessment, inspections, and market approval for foods, drugs, biotech products, cosmetics and medical devices.
The Division of Medical Devices & Cosmetics is in charge with the safety and quality control of medical devices, medical device regulation and clinical diagnostics as well as IVD devices.
Some of the most important regulations for medical devices in Taiwan are:
- Regulations Governing Management of Medical Devices
- Guidelines for Registration of Medical Devices
- How to apply for Medical Device License in Taiwan
A full list of TFDA regulations can be found here.
- Website: http://www.fda.gov.tw/EN/index.aspx