What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations?

#1
Would anyone be able to provide guidance with the following case, please?

A medical device is marketed in EU & US, with a EU company as legal manufacturer.
This medical device is made with a Taiwanese subcontractor. However, the medical device is not placed on the Taiwanese market.

Does the EU company needs to have a medical device TFDA registration or does it have to comply with other Taiwanese MD regulations at all?
And what are the obligations of the Taiwanese subcontractor towards medical device regulation in Taiwan?

Any advice would be helpful!
 
#2
Would anyone be able to provide guidance with the following case, please?

A medical device is marketed in EU & US, with a EU company as legal manufacturer.
This medical device is made with a Taiwanese subcontractor. However, the medical device is not placed on the Taiwanese market.

Does the EU company needs to have a medical device TFDA registration or does it have to comply with other Taiwanese MD regulations at all?
And what are the obligations of the Taiwanese subcontractor towards medical device regulation in Taiwan?

Any advice would be helpful!
 
#5
I am sorry. New format, I haven't been around for a while.
Messed that up didn't I?

I didn't realise, you can post before files have completed uploading.

I hope this is sufficient for you and good luck.
I am not a fan of Taiwanese marketing.
 

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