Free Sales certificates for Medical Devices - List of countries

#1
Hello,

I would be interested to see whether anyone of you has experience with free sales certificates for medical devices. Does anyone of you have a list of countries that would accept free sales certificates from an EU country? And would this also be the case for class 1 devices where CE conformity is self-declared?

Thanks a lot!
 
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shimonv

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#2
FSC is not regulatory clearance by itself. I've seen it mostly being used as part of a regulatory submissions in Asian countries were the FSC is one of the submission deliverables. In the case of class I devices, I suppose the FSC together with ISO 13485 certificate is the best you've got, but I doubt these alone will give market access outside the EU; Maybe in some African countries.
 
#3
ok thanks a lot, I know that you would still have to submit in each of the markets you are intending to use the free sales certificates, but as a starting point, does anyone know which countries are accepting them at all?

Thanks again
 

Sicco

Involved In Discussions
#4
Thailand, Indonesia, Taiwan, Vietnam, Myanmar, Iran, Egypt... as part of your registration submission. Ask your local distributors...
But anyway you cannot get FSC (In EU) without EC Cert and FSC alone is not enough for registration in these countries.
 
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