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Is there a requirement for country of origin on packaging of class 2a medical device?
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Is there a requirement for country of origin on packaging of class 2a medical device?
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class ii medical device, mdr (medical device regulations), country of origin requirements (coo), labels and labeling (general)
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  Post Number #1  
Old 17th October 2008, 12:01 AM
Pauling

 
 
Total Posts: 25
Please Help! Is there a requirement for country of origin on packaging of class 2a medical device?

Is there any requirement about marking country of origin on package of class 2a medical device?
Thanks so much!

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  Post Number #2  
Old 17th October 2008, 05:48 AM
Rocke's Avatar
Rocke

 
 
Total Posts: 56
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Dear Pauling,

I think that depends....
When exporting, certain countries requires Country of Origin Certificates etc.
Do you mean for international or domestic trade?
Which countries?

Best regards
Camilla
Thanks to Rocke for your informative Post and/or Attachment!
  Post Number #3  
Old 17th October 2008, 08:08 AM
chris1price

 
 
Total Posts: 256
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

I am not aware of any requirements within Europe, but other countries may have separate rules. The Country of Origin is required on packaging for product imported into USA.
Thanks to chris1price for your informative Post and/or Attachment!
  Post Number #4  
Old 17th October 2008, 08:15 AM
Pauling

 
 
Total Posts: 25
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Quote:
In Reply to Parent Post by Rocke View Post

Dear Pauling,

I think that depends....
When exporting, certain countries requires Country of Origin Certificates etc.
Do you mean for international or domestic trade?
Which countries?

Best regards
Camilla
Dear Camilla,
Sorry for my poor description on the question.
I mean international trade.
Actually i haven't knew where our product want to export to this time. Usually we add the "Make in **(country of origin)" in out package of our product. And some client asked whether it is ok to delected "Make in **" . I seached key word like"country of origin" in MDD&IEC 60601-1 and found nothing about our product. Also. I seached in google and concluded like you there are some country has trade requirement on marking of country of origin,just like USA, Mexico and so on.But i find nothing info about Country in EU. So i would like to know is there requirement on marking country of origin in any country of EU, and how i can get the detail about that. Thanks,again!
  Post Number #5  
Old 17th October 2008, 08:20 AM
Pauling

 
 
Total Posts: 25
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Quote:
In Reply to Parent Post by chris1price View Post

I am not aware of any requirements within Europe, but other countries may have separate rules. The Country of Origin is required on packaging for product imported into USA.
Dear Chris1price,
Thanks.
How about in Thailand, Argentina?
  Post Number #6  
Old 17th October 2008, 08:58 AM
chris1price

 
 
Total Posts: 256
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Within the EU, there is nothing in the MDD or other device standards requiring the country of origin to be on the label. The problem is that this type of regulation is frequently imposed by Customs or are local trade laws and have nothing to do with medical regulations.

Have a look at http://www.ita.doc.gov/td/health/regulations.html this is always a good source of information. Thailand appears to need Country of Manufacture on the label. Argentina does not say.
Thank You to chris1price for your informative Post and/or Attachment!
  Post Number #7  
Old 17th October 2008, 09:33 AM
Pauling

 
 
Total Posts: 25
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Dear chris1price,

Well noted with thanks!
  Post Number #8  
Old 10th September 2009, 03:47 AM
Raymond12

 
 
Total Posts: 24
Re: Is there a requirement for country of origin on packaging of class 2a medical dev

Hi all,

Is there any current/ expected medical device regulations in the EU or U.S that dictates that medical device companies must put country of origin on the product?

Thanks
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