Argentina IVD Registration Requirements

M

missjenny

Involved In Discussions
#1
#1
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
 
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B

bisbita

#3
#3
Hi mate, I do not know if it will help you but...

several times, when I speak with different dealers in Argentina, they always ask for the same information, in the same way: You will need for sure..

1. Technical Specifications BY MAIL
2. instructions, BY MAIL
3. processing flowchart BY MAIL
4. Essential Principles Checklist BY MAIL
5. Labelling BY MAIL
6. Declaration where equipment were sold, LETTER WITHOUT APOSTILLE
7. Free Sale Certificate, WITH APOSTILLE
8. LETTER AUTHORIZATION WITH APOSTILLE
9. LETTER OF COMMITMENT WITH APOSTILLE
 
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