Is CFDA registration required if the full system is registered by our distributors?

Hello,

These might seem as a strange question but I didn't find any clear explanation for a similar situation :

We manufacture medical devices that needs to be associated with other components such as air compressor and tank receivers to operate.

Our final clients in China (Chinese hospitals) only require a CFDA registration certificate"医疗器械注册证? for the full system (= our medical device + these other components) and no individual CFDA registration for our medical device.

If the full system is registered by our distributors (we are ok with this)...do we still need to possess an individual registration of our devices with the CFDA at any point of the process (during control by CIQ at the border ? other stage of the selling process ?) ?

Any help on that matter would be more than welcome!
谢谢!

Re: Is CFDA registration required if the full system is registered by our distributor

A Quick Bump!

Can someone help?

Thank you very much!!

Re: Is CFDA registration required if the full system is registered by our distributor

Hi,

I assume that you are a foreign manufacturer. As a foreign manufacturer (I assume you are!), you must have a local presence in terms of your own office or a distributor to register your products on your behalf. In this case, your distributor can register products (as a system, depending up on CFDA acceptance and type of accessories) and the registration cert will be on distributor's name with you as a foreign manufacturer. There won't be any separate registration certificate given to your name.

Regards,
Sreenu