Pre-Approval Requirements - Exporting Medical Devices to China from the US

[Sarah-Shangh]

Hello,
I have read that U.S. manufacturer who wants to export medical devices to China must first have been approved their product in the country of origin for sale? Without this certificate China does not accept the product registration documents. Is this true?
I need this information for my essay.
Thanks in advance!
Sarah

 

[Stijloor]

A Quick Bump!

Can someone help Sarah?

Thank you very much!!

Stijloor.

 

[Marc]

Another quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[MIREGMGR]

Hello,
I have read that U.S. manufacturer who wants to export medical devices to China must first have been approved their product in the country of origin for sale? Without this certificate China does not accept the product registration documents.

Yes, SFDA does require evidence that a USA-manufactured medical device to be marketed in China is legally marketable in USA.

It might be possible to arrange with SFDA some alternate path to legal China marketing, in the case of a USA-made product that is developed specifically for export and isn't marketed in USA. I don't know how SFDA would handle such an instance. In the general case, they obviously want China-marketed devices to have the same safety, effectiveness and quality as USA-marketed devices.

 

[sreenu927]

Yes, as MIREGMGR said, SFDA requires Free Sales cErtificate from the Country of Origin. If your product is not intended to sell in US (Country of Manufacture), then I think one solution may be the having a similar statement on the label ,"Not for sales in USA" or " For sale in China only".
Then you may avoid submitting the FSC requirement.

Regards,
Sreenu