Taiwan Medical Device registration - Production or legal office

[bisbita]

The information that I am looking for has not been published or maybe I could not find it. I really hope you to help me. It is related to Medical devices.

The manufacturer has two addresses, one is where they make the product, and the other one is where they have their legal office. Both are placed in different cities. (in that case same country)

And my question is: do they have, these two addresses, to appear in the product registration? Or just one would be fine?

thank you so much guys

 

[Ronen E]

Re: MD registration Taiwan - production or legal office

Which registration are you referring to?

 

[bisbita]

Medical devices, sorry!!

 

[Ronen E]

What region / country / standard etc.?

 

[bisbita]

we are based in Europe, Italy. We had some others problems with other registrations in Asia. In some certifications we have two addresses, the legal office and the production office... that is why..

 

[Ronen E]

we are based in Europe, Italy. We had some others problems with other registrations in Asia. In some certifications we have two addresses, the legal office and the production office... that is why..

I'm sorry, but I'm still not able to understand what certifications / registrations exactly you refer to. Is it ISO 13485?

 

[bisbita]

well.. my question were more general, but, yes, the ISO 13485 is one of the main points. also, for Free sales certificates or powers of attorney.

Did I say thank you?

Thanks mate