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Medical Device Registration in Argentina - Client asks us to provide “European FSC”

Jose

Registered
#1
Hello,

Our factory is in China, and my Argentinian client asks us to provide “European FSC” for registration.
I check ANMAT web site, the required document for procedure only shows FSC (apostille /consularized ) [ the original words: CLV vigente(apostillado/consularizado, traducido y autenticado u original).]

does anyone have experience of Argentina registration for import medical device recently?!
I’d like to know it needs “European FSC” or “Consularized FSC” ?

Thank you.
 
#2
Hi Jose,

Yes, we did this recently. If you don't actually sell (or perhaps qualify to sell) into the EU, you can't get an EU FSC. We typically get ours from Germany for a variety of jurisdictions (edit) but according to the link you can also use the U.S., Canada, Japan, Switzerland, or Australia. I fear that if you can't come up with an EU CFS, you'll need to take a different regulatory pathway that is much more involved (e.g. Argentinian authorities auditing your factory - but not sure). You'll also need a letter of authorization and also a history of commercialization, if my memory serves me.

EDIT: This seems to indicate that there is no alternative pathway, not sure if it is up to date (looks like it was produced in 2013): https://static1.squarespace.com/sta...20ee4b0aded9e49d719/1411662350786/Emergo2.pdf

EDIT: regarding your questions on legalization/apostille - Argentina is a member of the Hague Convention on Apostilles so if you are receiving the certificate from another member country, it does not need to be consularized, only apostilled.

Hope this is of some help and provides a good starting point for further research.
 
Last edited:

Jose

Registered
#3
Hi Supadrai,

Thank you very much for your reply.
Actually, we also sell our products into the EU. We just don't understand why it needs EU FSC for registration in Argentina.
Thanks for all information, it helps me a lot.

Have a good day.
 
#4
Some countries rely upon the compliance (evidenced by a FSC) of the product in other countries (but not the country of origin - e.g. Thailand, where we are) to provide an easier pathway for registration as they may not have the desire or resources to conduct audits or otherwise verify/validate the import of safe and effective medical devices.
 
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