Taiwan’s Food and Drug Administration (TFDA)
Medical Devices
In Taiwan Medical Devices are regulated by the Taiwan Food and Drug Administration (TFDA), Taiwan’s equivalent of the United States FDA. The TFDA rests under the authority of The Ministry of Health and Welfare (MOHW) who performs on-site inspection for local manufacturers and reviews Quality System Documentation (QSD) provided by foreign manufacturers.
Medical Device Regulations:
Taiwan’s Pharmaceutical Affairs Act regulates the administration of pharmaceutical affairs, which includes drugs and medical devices, pharmaceutical firms, pharmacies, and other relevant matters. Various regulations were established pursuant to the Pharmaceutical Affairs Act to expand on the details not specifically covered in the Act.
Market Authorization :
All imported medical devices must obtain a registration certificate from the TFDA. The regulatory process for new medical devices in Taiwan is often complicated and unclear. Most of Taiwanese regulations are in the Mandarin Chinese language and are constantly being changed by the TFDA health authorities.
GRP Medical Device Services :
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts and affiliated partners in Taiwan who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Taiwan’s market.
More Resources:
- TFDA check website
- More information is available under “Read More” Tab
