Taiwan: FDA launched online submission of application

ARQon
Jun 24, 2022
1 min read

The Taiwan Food and Drug Administration (FDA) launched the Premarket E-Submission Portal on 21 January 2022 to simplify the submission process of applications for manufacturers. This system can be used for application of Class II and III Medical Device registration, alteration of the registration, and license extension. Although this system is not mandatory, manufacturers are encouraged to use it to expedite the application process.

Overview of Registration Process

The Taiwan FDA is a division of the Ministry of Health and Welfare that oversees the medical device registration in Taiwan. Administration Review is necessary for all classes of devices, while Technical Review and Quality System Document (QSD) Review are only required for Class II, III, and new devices. Although the review fees in Taiwan have been on the rise, they are still affordable as compared to other markets in the region. Licenses issued in Taiwan is only valid for 5 years and are transferrable when completed jointly by both the transferee and transferor.

Faster Market Access for US/EU Approved Devices

This can hasten the process as existing documentation can be used instead of the preclinical test, quality control procedure and test reports for Class II US/EU medical devices. This does not apply to Class III IVDs and New products.

Source:

Taiwan Food and Drugs Administration