Veronika336655
Registered
Hello everyone. We are a manufacturer of a sterile medical device of risk class IIb (in accordance with European regulations). Now we are at the beginning of the way to obtain an ISO 13485 and CE certificate.
We would like to consider other countries to enter the market that do not require СE mark or FDA.
I have already seen an article on "regdesk" about countries that do not have an official regulatory approval process, but this article is quite old and most likely the legislation has changed in many countries.
Perhaps you have some newer information or experience of registration in a country that does not require certificates and does not have a complicated approval process for a medical device?
Please share the names of these countries.
We would like to consider other countries to enter the market that do not require СE mark or FDA.
I have already seen an article on "regdesk" about countries that do not have an official regulatory approval process, but this article is quite old and most likely the legislation has changed in many countries.
Perhaps you have some newer information or experience of registration in a country that does not require certificates and does not have a complicated approval process for a medical device?
Please share the names of these countries.
