Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
220 days
performance goal
Legal time limit
-
Not published
Steps
7
9 requirements
Application fee
NT$130,000
Fee standard amended 2023-02-23
Devices, including IVDs, with no similar product licensed or listed in Taiwan follow a longer review that includes the device advisory committee. The fee covers new principles, structures, materials or performance claims. New technology without a comparable device already approved in Taiwan.
The official review target is 220 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The new principle, structure, material, performance or no similar product review fee is NT$130,000 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. Decision; 7. 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 Articles 2 and 6
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. | 220 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New principle, structure, material, performance or no similar product review feeApplication · Fee standard amended 2023-02-23 | NT$130,000 |
Other routes in Taiwan: Class 1 device listing, Class 1 device license, Class 2 device license, Class 3 device license, License for a world-first device, 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.