Eric Leung

“While not required, the Taiwan FDA is encouraging manufacturers and their in-country representatives to use the ePortal to help expedite the review process.”

Eric Leung
General Manager
Asia Actual Taiwan

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Taiwan FDA Launches New E-Submission Portal for Submitting Applications

Published on: May 10th, 2022

Paperless Submissions Now Permitted in Taiwan

Following many other Asian markets, the Taiwan Food and Drug Administration has implemented the Premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications. The new system was launched on March 31, 2022 and is available to Class II and III products and will allow for a paperless submission. This comes after the updated regulations went into effect in 2021 and hopes to help expedite the application process. Manufacturers don’t need to use the system but are encouraged to. The TFDA’s announcement can be found here.

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.

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