China registration update medical devices

[GiuliaGe]

Good morning everyone!

My name is Giulia and I work as Regulatory Affairs Specialist in a company that produces active medical devices.

I would like to ask your advice on extending registration in China.

our device is currently registered in china as a CE product and we are in the process of updating this registration.
since it is not required for commercial purposes we were thinking of updating the registration with a more up to date but non CE (EUROPA) device. is this possible?

the steps required for registration in china require you to demonstrate proof of home country approval using documentation such as a Certificate of Free Sale (FSC). is it possible to do this demonstration with a non-EC DM?
and especially if during the initial registration of the device it was presented as CE with the FSC is it possible to extend this registration with this modification?

Thak you very much for the help
Giulia

 

[shimonv]

hi Giulia,
Your question is unclear. You wrote that "our device is currently registered in china as a CE product". The Chinese license stands on its own...

 

[GiuliaGe]

I apologise for the unclear message.
Obviously the device is sold in China and is registered with NMPA as a medical device.
Until now, the product additionally bore the CE mark for commercial purposes.
We have now been asked to update the registration in China to add some changes to the product. The product thus modified does not yet have approval in Europe due to the transition from MDD to MDR. So we would have to update the registration in china from a device that bore the CE mark to one that does not.
Does the machine need to be CE marked to be approved in China?
Is it necessary for it to retain the CE mark if it originally had it during the first registration in NMPA?
Also, if it is possible to update the registration without the machine being CE, what documentation can replace the certificate of free sale?

Thank you very much
Giulia

 

[shimonv]

Okay, so the license update of an existing product in China does not depend on the CE status. However, if you cannot produce a valid certificate of free sale you have a problem.
If your product is registered with FDA, you might be able to obtain a Certificate of Foreign Government (CFG) and use it instead. Obviously, the details matter...

Good luck,
Shimon