M
Hello,
As a medical device manufacturer based in Korea looking to enter the Argentine market, we would highly appreciate it if you could let us know whether it is imperative that we submit Evidence of Commercialization.
The reason for asking is that we want to market our latest products, which are CE marked but have little to no history of being marketed anywhere.
Based on the articles below, it seems like it would be impossible to market new products in Argentina due to this requirement. Would selling ten IVDs in Europe be enough? A hundred? A thousand? For over a year? Or if you do not have a history of commercializaiton you are not required to submit anything except for Certificate of Free Sale (CFS) or Country of Origin Approval,which we do have.
http://www.aptivsolutions.com/blog/...tina-updates-general-law-for-medical-devices/
http://www.emergogroup.com/blog/2013/02/changes-medical-device-regulations-argentina-effect
http://www.kjinternational.com/articles/recent-changes-to-medical-device-regulations-in-argentina
As a medical device manufacturer based in Korea looking to enter the Argentine market, we would highly appreciate it if you could let us know whether it is imperative that we submit Evidence of Commercialization.
The reason for asking is that we want to market our latest products, which are CE marked but have little to no history of being marketed anywhere.
Based on the articles below, it seems like it would be impossible to market new products in Argentina due to this requirement. Would selling ten IVDs in Europe be enough? A hundred? A thousand? For over a year? Or if you do not have a history of commercializaiton you are not required to submit anything except for Certificate of Free Sale (CFS) or Country of Origin Approval,which we do have.
http://www.aptivsolutions.com/blog/...tina-updates-general-law-for-medical-devices/
http://www.emergogroup.com/blog/2013/02/changes-medical-device-regulations-argentina-effect
http://www.kjinternational.com/articles/recent-changes-to-medical-device-regulations-in-argentina