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

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china, country of origin requirements (coo), exports and exporting, imports and importation, medical device registration, united states (usa), medical devices
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  Post Number #1  
Old 23rd February 2012, 07:06 PM
Sarah-Shangh

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

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

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  Post Number #2  
Old 24th February 2012, 05:31 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Pre-Approval Requirements - Exporting Medical Devices to China from the US

A Quick Bump!

Can someone help Sarah?

Thank you very much!!

Stijloor.
  Post Number #3  
Old 2nd March 2012, 12:57 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,672
Re: Pre-Approval Requirements - Exporting Medical Devices to China from the US

Another quick "Bump". My Thanks in advance to anyone who can help with this one.
  Post Number #4  
Old 2nd March 2012, 10:50 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Pre-Approval Requirements - Exporting Medical Devices to China from the US

Quote:
In Reply to Parent Post by Sarah-Shangh View Post

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.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #5  
Old 4th March 2012, 09:58 PM
sreenu927

 
 
Total Posts: 541
Re: Pre-Approval Requirements - Exporting Medical Devices to China from the US

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
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