Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
-
For devices with clear benefit and no major risk that meet an unmet or urgent need, or that are innovative, the TFDA can grant a license with a shorter validity linked to a safety surveillance or post-market study plan. Promising devices where some evidence will be gathered after approval.
1. License application with a surveillance or post-market study plan; 2. Review; 3. License with a shorter validity; 4. Safety surveillance or post-market study.
Outcome: Device license with a shorter validity and study obligations.
Legal basis: Device license, listing and annual reporting regulation Article 12
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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, License for a world-first device, In vitro diagnostic device license (Class 2 and Class 3), Device priority review, 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.