Strategy for Registration a Medical Device in China

[belemsanchez]

Please, I need help with this registration because I don't know what strategy to follow, I'm explaining:
We are the manufacturer of a medical device (class I MDD) but class II to CFDA. We want to register in China. The "problem" is that our MD is manufactured in China by a subcontractor located at China. Then, our MD is shipped to us in bulk, for packaging and labelling under own name.

We don't want to explain it to CFDA, an we want to register the MD as foreing, not domestic. but I've been notified that CFDA can request for audit ISO reports, Facilities layout, Clean-room certificates,...and its name appears in these documents or belong to him, do you know if this situation is allowed by CFDA?

Thanks in advance

 

[shimonv]

Hi belemsanchez,
I don't think this approach will work because the device is manufactured in China and the final assembly and testing records will show it.
CFDA will not give you a foreign license for a domestic device.
Perhaps you can opt for a semi knock-down approach, meaning after they assemble the whole device they will break it down to 2-4 sub-assemblies and you will do the final assembly and packaging in your factory.


Cheers,
Shimon

 

[Gamula]

Dear belemsanchez,

really interesting situation, which it is not seldom: Chinese OEM and non Chinese manufacturer.

I was curious and I found the following information from August 2016:

"...if a Chinese manufacturer is to be the Original Equipment Manager (OEM), the product must be registered under the local manufacturing company, not the foreign device manufacturer."

But there is, of course, a speciality:

"If the foreign manufacturer has its own Chinese facility and Good Manufacturing Practice (GMP) certificate, it may outsource some of the manufacturing and then register directly in its name with the CFDA."

Maybe, this helps you.

Best regards
Gamula