Taiwan · Taiwan Food and Drug Administration · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
5 requirements
Application fee
NT$10,000
Fee standard amended 2023-02-23
Low-risk Class 1 items that the regulator has announced are placed on the market by online listing instead of a license. The listing must be confirmed every October or it lapses. Class 1 devices on the regulator's list of items handled by listing.
The device listing fee is NT$10,000 for Fee standard amended 2023-02-23.
1. Online listing; 2. Annual report every October.
Outcome: Listing number; the device can be made or imported.
Legal basis: Medical Devices Act Articles 25 and 28; device license, listing and annual reporting regulation Articles 20 to 22
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 listing feeApplication · Fee standard amended 2023-02-23 | NT$10,000 |
| Annual listing report feeYearly · Fee standard amended 2023-02-23 | NT$2,000 |
Other routes in Taiwan: 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, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.