Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
NT$10,000
Fee standard amended 2023-02-23
The TFDA can approve the manufacture or import of specific unlicensed devices for serious diseases without alternatives, emergencies, trials, samples, personal use and some other listed cases. Patient need, emergencies or other listed cases where no licensed device is available.
The special approval fee (critical or severely disabling condition, research, trials, exhibition) is NT$10,000 for Fee standard amended 2023-02-23.
1. Request for special approval; 2. Review; 3. Special approval.
Outcome: Special approval for a defined manufacture or import.
Legal basis: Medical Devices Act Articles 35 and 36
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 |
|---|---|
| Special approval fee (critical or severely disabling condition, research, trials, exhibition)Application · Fee standard amended 2023-02-23 | NT$10,000 |
| Special approval fee for personal useApplication · Fee standard amended 2023-02-23 | NT$2,000 |
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 priority review, Device license with shorter validity and post-market study. 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.