Medical Device Registration in Taiwan

Click here to visit the Taiwan FDA (authority) website.

Requirements for QSD (Good Manufacturing Practice):

1. Quality Manual

2. SOP list

3. ISO 13485 certificate

4. CE certificate (if available)

Requirements for medical device registration in Taiwan:

1. Application form (MAH’s company seal and representative’s chop is required)

2. A copy of pharmaceutical firm permit license as a medical device dealer (MAH)

3. Written statement of MAH (MAH’s company seal and representative’s chop is required)

4. Instructions and manual with detailed Chinese translations, packaging, labels and colour pictures of the physical appearance of product. 

5. Legalized FSC from the country of origin

6. Letter of authorization (Manufacturer authorizing MAH)

7. Pre-clinical testing and the test specifications and methods, the original test records, and the certificate of analysis of the quality control conducted by the original manufacturer

8. Relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the above-mentioned items may be a substitution.

9. Theoretical basis and relevant research reports and data

10. Clinical trial reports

11. If the Manufacturer is regarded as a contract manufacturer of MAH. A contract between Manufacturer and MAH stating contract manufacturing is required

12.Radiation safety information if the device generates radiation.

Item 9 and 10 can be exempted if a similar product is already registered in Taiwan.

MAH = local license holder