Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
365 days
performance goal
Legal time limit
-
Not published
Steps
8
5 requirements
Application fee
NT$250,000
Fee standard amended 2023-02-23
Devices that are first in the world, with no similar product anywhere, are reviewed with a foreign maker site inspection and a clinical trial in Taiwan instead of a certificate of free sale. Devices not yet approved in any other market.
The official review target is 365 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The world-first device license review fee (includes foreign maker inspection) is NT$250,000 for Fee standard amended 2023-02-23.
1. Submit the license application; 2. Formal (completeness) review; 3. Substantive review; 4. Applicant supplies data (clock stopped); 5. Advisory committee review; 6. Foreign maker site inspection; 7. Decision; 8. Collect the license.
Outcome: Device license valid up to 5 years and renewable. Valid for 5 years.
Legal basis: Medical Devices Act Article 25; device license regulation Annex 2
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 91 days end to end with the official step targets, of which up to 91 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Review targetperformance goal. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| World-first device license review fee (includes foreign maker inspection)Application · Fee standard amended 2023-02-23 | NT$250,000 |
Other routes in Taiwan: Class 1 device listing, Class 1 device license, Class 2 device license, Class 3 device license, License for a device with no similar product in Taiwan, In vitro diagnostic device license (Class 2 and Class 3), Device priority review, Device license with shorter validity and post-market study, Special approval to make or import unlicensed devices. See all routes on the Taiwan page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet