China Medical Device Labeling - Not approved for use, is for an exhibition

[fialor]

Hi All,
Are they any medical device labelling requirements for products which are not approved for use in China but which one needs to take to exhibitions there?
Perhaps in the vien of the requirement for the USA?
Thanks
Fialor

 

[Marc]

Re: China Medical Device Labeling

A weekend "Bump" - Anyone here able to help with this question?

 

[Ronen E]

Re: China Medical Device Labeling

This is a place where I would start looking for an answer.

Unfortunately I don't have direct experience in this kind of situation and I also don't read Mandarin too well

Google Translate does, however, to an extent. But there's a risk in using it that must be acknowledged.

 

[fialor]

Re: China Medical Device Labeling

Thanks Ronen E - really useful resource.

 

[Access2hc]

Re: China Medical Device Labeling

there are a few factors...

1 - there are no specific labeling requirement
2 - needs the agreement with the exhibitor or conference to verify that this is a demo
3 - preferred to have a label that says it is a demo and not for sale
4. check with the importer (impex) company into China to investigate which are the less 'troublesome' ports.

hope that helps.

Cheers,
Ee Bin