Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
200 days
performance goal
Legal time limit
-
Not published
Steps
6
9 requirements
Application fee
NT$100,000
Fee standard amended 2023-02-23
High-risk Class 3 devices need a TFDA license with full preclinical and clinical evidence. Drug-containing devices that work mainly as devices are placed in Class 3. Class 3 devices, high-risk software and device-led drug-device combinations.
The official review target is 200 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class 3 device license review fee is NT$100,000 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. Decision; 6. 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 classification regulation Article 4; device license regulation Article 6 and 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
What the applicant must provide or meet
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. | 200 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Class 3 device license review feeApplication · Fee standard amended 2023-02-23 | NT$100,000 |
Other routes in Taiwan: Regenerative medicinal product license (cell, gene, tissue engineered and composite products), Conditional permit for regenerative medicinal products, Class 1 device listing, Class 1 device license, Class 2 device license, License for a device with no similar product in Taiwan, License for a world-first device, 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.