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Taiwan’s New TCP III in Effect as of January 1, 2022
Published on: September 2nd, 2022
Originally announced in May of 2021, the Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022. The TCP program was established to help expedite the Quality System Documentation (QSD) portion of the TFDA’s review by accepting ISO 13485 audit reports from designated European Notified Bodies. The following Notified Bodies are participants of the TCP program and the official announcement can be found here.
- TÜV SÜD Product Service GmbH Zertifizierstellen
- TÜV Rheinland LGA Products GmbH
- MDC Medical Device Certification GmbH
- MEDCERT Zertifizierungs- Und Prüfungsgesellschaft Für Die Medizin GmbH
- DEKRA Certification B.V.
Manufacturers prioritizing the Taiwanese market after receiving CE Marking should consider using one of the approved Notified Bodies to help expedite their market access.
Registration 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.