Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
NT$180,000
Fee standard amended 2023-02-23
A device license application can be reviewed with priority when the device addresses a life-threatening or severely disabling disease without alternatives, a rare disease, or an urgent need, including government-supported products tested in Taiwan. Devices for serious unmet needs or rare diseases.
The device priority review fee is NT$180,000 for Fee standard amended 2023-02-23.
1. Priority review request with evidence; 2. Prioritized license review; 3. Decision.
Outcome: The license application is handled with priority.
Legal basis: Device license, listing and annual reporting regulation Article 9
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 |
|---|---|
| Device priority review feeApplication · Fee standard amended 2023-02-23 | NT$180,000 |
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, License for a world-first device, In vitro diagnostic device license (Class 2 and Class 3), 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.