● The application procedures of Medical Devices in Taiwan was listed bellow.
1st step》 Quality System Documentation (QSD)
Before a medical device can be sold in Taiwan, besides medical device registration, QSD registration for the manufacturing facility is required.
But Class I (non-sterile) medical devices can be waived for QSD registration. A QSD license (received upon QSD registration approval) in Taiwan, is similar with Quality Management System (QMS) for medical devices.
2nd Step》 Product Registration Process
Before importation and sale of a medical device (Class I, II, III, or PMA) in Taiwan, the device needs to be registered and approved by the TFDA.
The TFDA issues a "medical device product license" upon product registration approval.
Class I
- Class I medical devices without brand names (e.g. surgical instruments or power accessories) usually follow a simple self-declaration process in Taiwan.
- Timeline: The Class I registration approval process takes about 3 months.
Class II & III
- TFDA 90 days- Approval or Notice for deficiency
- If Notice for deficiency, 90 days+30 days to answer deficiency
- After answering deficiency, 90 days approval or rejection
- If being rejected, within 120days to appeal
■ PMA Medical Devices
- TFDA 90 days- Approval or Notice for deficiency
- If Notice for deficiency, 90 days+30 days to answer deficiency
- After answering deficiency,- decision or sending to Committee Review within 120 days
- If sending to Committee, within 60days approval or rejection.
- If being rejected, within 120days to appea