Taiwan · Taiwan Food and Drug Administration · Diagnostics (IVD)
Review target
150 days
performance goal
Legal time limit
-
Not published
Steps
6
8 requirements
Application fee
NT$100,000
Fee standard amended 2023-02-23
In vitro diagnostic reagents, instruments and software are medical devices in Taiwan. Class 2 and Class 3 IVDs need a TFDA license under the same rules as other devices, with their own processing periods. Medium and high-risk IVDs. Some Class 1 IVDs use listing.
The official review target is 150 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The class 3 ivd 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 Articles 3 and 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.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Class 2 IVD. Official processing period in calendar days, as announced by the TFDA. It is a target, not an actual review time. | 150 days |
| Typical total timeperformance goal. Class 3 IVD. 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 IVD license review feeApplication · Fee standard amended 2023-02-23 | NT$100,000 |
| Class 2 IVD license review feeApplication · Fee standard amended 2023-02-23 | NT$58,000 |
Other routes in Taiwan: Class 1 device listing, 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.