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Selling Medical Device Abroad After the Expiring Date of the EC Certificate

D

Denar

#1
After the expiring date of the EC Certificate (the one released in the manufacturer country) of a Medical Device, can I sell this device to an abroad market if the device is registered in this country and has it own abroad certification?

Where can I check for a regulatory confirmation?

Thanks
 
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Marcelo

Inactive Registered Visitor
#4
Sorry, I did not mention it in that way. CE Marking (and the related EC certificate) is required by Europe. For any other country/region, you need to identify the regulatory requirements.

Some countries require things like a free sale certificate or proof of manufacturing permission (usually by requiring the "registration"information in the home country). For the EU, you sometimes (again, depending on the target regulations) use the EC certificate as this proof.

So, if the target country requires this, and the EC certificate is the way to show it, and your EC certificate is not valida anymore, you would not be able to enter the target market.

There's several nuances in it, so I would take care. For example, you mentioned that is already registered in the target country. You would need to check if you use the EC certificate in the way I mentioned, and, if so, if constant compliance (meaning, constantly having a valid EC certificate) is required as part of maintaining the registration in the country. Some countries only require it for the registration process, other require that it is always valid.
 
D

Denar

#5
Sorry, I did not mention it in that way. CE Marking (and the related EC certificate) is required by Europe. For any other country/region, you need to identify the regulatory requirements.

Some countries require things like a free sale certificate or proof of manufacturing permission (usually by requiring the "registration"information in the home country). For the EU, you sometimes (again, depending on the target regulations) use the EC certificate as this proof.

So, if the target country requires this, and the EC certificate is the way to show it, and your EC certificate is not valida anymore, you would not be able to enter the target market.

There's several nuances in it, so I would take care. For example, you mentioned that is already registered in the target country. You would need to check if you use the EC certificate in the way I mentioned, and, if so, if constant compliance (meaning, constantly having a valid EC certificate) is required as part of maintaining the registration in the country. Some countries only require it for the registration process, other require that it is always valid.
Thanks very much for the explanation.
So, if Russian market does not required an always valid EC certificate I can sell MDs in this market even after the European EC certification of that device has expired. Correct? Thank you
 

Marcelo

Inactive Registered Visitor
#6
Thanks very much for the explanation.
So, if Russian market does not required an always valid EC certificate I can sell MDs in this market even after the European EC certification of that device has expired. Correct? Thank you
Yes, as long as you comply with Russian regulations.
 
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