Labeling Requirements for Medical Devices Made in China

[JoCam]

Hi All,

I heard recently that all medical devices that have been manufactured in china must now state directly on the product 'Made in China', and that this is the case even if the Chinese manufacturer is a sub-contractor and not the legal manufacturer. Is this correct?

Jo

 

[Access2hc]

if it's on OEM based in China, and delivered to the Chinese market, yes. there are of course some commercial advantages but does pose problem for the market entry to other countries sometimes..

Cheers,
Ee Bin

 

[JoCam]

Thank you for your reply Access2hc, but we are based in the UK and will be having the component that we designed manufactured in China using a sub-contract manufacturer. The item is just a component and we will not be getting it CE marked in it's own right as it will form a part of our completed system, which will be CE marked. So do we still need it to have 'Made in China' stamped on it?

Jo

 

[Access2hc]

if it is a component and it's shipped out for final assembly then packaging then imported back into China again the answer is no for the 'made in.. ' . then just comply with the local labeling requirements.

hope that helps

Cheers,
Ee Bin

 

[shimonv]

I heard recently that all medical devices that have been manufactured in china must now state directly on the product 'Made in China.

Hi Jo,
It seems to me that few pieces of information are missing; you didn't write wehre the probelm is...

Is this something like a PCB manufactured in China and you do the final assembly in the UK before marketing in the EU?
Or is it something more complete like a power supply unit that comes with its own casing and label?

Shimon

 

[JoCam]

Hi Shimnov,

This is a connector to control air flow, manufactured in China to our design. Once returned to us it will be attached to an umbilical and used to connect the main parts of our system, a power unit (pump) and the device itself.

Jo

 

[shimonv]

I see.. so I'm not aware of any EU regulation that requires imparting the country of origin on such a component. In a sense it's any different from a screw, power adapter, capacitor, etc.

I hope this helps..

Shimon