TFDA - Taiwan Food and Drug Administration

Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality. The TFDA deals with risk assessment, inspections, and market approvals for foods, drugs, biotech products, cosmetics, and medical devices.

The Division of Medical Devices & Cosmetics is in charge of the safety and quality control of medical devices, medical device regulation, and clinical diagnostics, as well as IVDs.

A list of TFDA regulations can be found here on our website.

Contact details:

• Website: http://www.fda.gov.tw/EN/index.aspx

Related services for Taiwan:

• Medical device registration in Taiwan

​Related resources:

• Taiwan Medical Device Regulations
• Taiwan TFDA Approval Process for Medical Devices