Registration Process Overview in Taiwan
In Taiwan, medical device registration is overseen by the Taiwan Food and Drug Administration (Taiwan FDA), a division of the Ministry of Health and Welfare. Class I devices will go through an Administrative Review, and Class II, III, and New devices (no predicates) will go through both an Administrative and Technical Review, as well as a Quality System Document (QSD) Review. While fees have increased in Taiwan, the review fees are still relatively affordable compared to other markets in the region.
Once issued, licenses are valid for 5 years. Licenses in Taiwan are transferrable and will need to be completed by both the transferor and the transferee jointly. To learn more about the regulatory process in Taiwan, please click here.
Expedited Market Access For US/EU Approved Devices
Clinical data is only required for Class III IVDs and New products. Class II medical devices with approval in the US or EU can usually use existing documentation in place of the preclinical test, quality control procedure and test reports.
Grow with Us
Asia Actual is available to help navigate the medical device registration requirements and regulatory pathway for medical device and IVDs in Taiwan.
Contact Asia Actual for more information discussing the potential for your medical device or IVD in the Taiwanese market.