Taiwan Medical Device Importation

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!

tehuff said:

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!

Click to expand...

Check this link out:

http: //www .ita. doc .gov /td/health/taiwan_equip_registration05.pdf - DEAD 404 LINK UNLINKED

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.

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”

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.

Hi every one on the same subject (Taiwan) can anyone help me as to where the medical device application needs to be submitted to (e-mail address, physical location)? I have not been able to find it.

Here is the website https://oap.fda.gov.tw/B101?type=3 , but you can imagine that it is in Chinese, and the physical location is No.161-2, Kunyang St, Nangang District, Taipei City 11561, Taiwan, where you do the document submission, but the office is actually in the Science Park about 20/30 mins away.

gus0457 said:

Hi every one on the same subject (Taiwan) can anyone help me as to where the medical device application needs to be submitted to (e-mail address, physical location)? I have not been able to find it.

Click to expand...

You will need a local representative in Taiwan first (required by regulation) and then submit the application to TFDA.

Hi everyone, I wonder if you can advise if as a foreign manufacturer, can we appoint different distributor to register the same medical device in Taiwan please? I've been trying to search information online and understand that the device license is transferable. But I'm trying to find out if we can have more than one distributor to hold registration for same device.

Many thanks!