Taiwan Medical Device Importation

[tehuff]

Hi,
I have a client who would like to provide one device (MRI coil - class II device cleared in the US) for testing to Taiwan. My understanding is that the testing will be compatibility testing with another machine and will not involve patients. I know Taiwan has a market approval/license process, but are there any other "exception" routes for importing devices for situations like this? What other information about the testing should I be asking?
Thanks as always!

[Ronen E]

In Reply to Parent Post by tehuff

Hi,
I have a client who would like to provide one device (MRI coil - class II device cleared in the US) for testing to Taiwan. My understanding is that the testing will be compatibility testing with another machine and will not involve patients. I know Taiwan has a market approval/license process, but are there any other "exception" routes for importing devices for situations like this? What other information about the testing should I be asking?
Thanks as always!

Check this link out:

http://www.ita.doc.gov/td/health/tai...stration05.pdf

If you feel you might need some inside help (from a local), I might be able to assist you, but the guy may charge a fee. Please send me a PM if interested.

Good luck,
Ronen.

[bio_subbu]

Hi

I could not able to help for your exact situation, but the following is the process flow to get product registered with Taiwan "DOH’s Bureau of Pharmaceutical Affairs (BPA)" to import medical devices.

1. Letter of authorization (must authorize Taiwanese agent to register product)

2. Free Sale Certificate (demonstrating that product is freely sold in its home market)

3. Leaflet/Catalog (specifying product usage – 3 copies are required)

4. Quality control (including testing methods and testing results)

5. Product specifications (form, structure, dimensions, raw materials or ingredients, quantity, performance, purpose of use, and effects)

6. Sample (if device is extremely heavy or bulky, or if other special circumstances apply, sample may be replaced by pictures that identify the structure, properties, and form of the device)

7. Clinical trial reports (required for certain medical devices such as newly developed devices or approved devices with new applications)

8. Circuits and testing records of electric insulation and duration (required for electronic equipment)

9. Instructions for operating security (required for electronic equipment)

10. Operation records of automatic measurement adjustment (required for automatic temperature adjusting equipment)

11. Testing record and certificate of radiation leakage (required for radioactive equipment)

For more information refer attached document “How to apply for Medical Device License in Taiwan”

[pseudoazurin]

You can also try Taiwan FDA's website www.fda.gov.tw You can forward your enquiry to them. They are pushing harmonization of medical device regulatory requirement.