Spanish term (edited): \"de libre venta\"

Foreign manufacturers may now submit a Certificate of Free Sale (CFS) or Country of Origin Approval from any country to ANMAT. However, whether or not ANMAT accepts at CFS will be determined based on how similar the issuing agency’s regulatory actions post-market surveillance activities are to those of the Argentinean regulator. The new requirements do not include a list of reference countries, but valid registrations in markets such as the US, Europe, Canada, Japan and Australia will likely be acceptable to ANMAT.

https://www.emergogroup.com/blog/2013/02/changes-medical-dev...

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Note added at 4 mins (2017-10-20 21:27:43 GMT)
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Regulatory Agency

The National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT) under the Ministry of Health is the regulatory authority. Products covered under the Resolution 255/94, Decree No. 2.505/95 must be registered with ANMAT. The importer is responsible for registration of products by submitting a product report of technical information including documents that are legalized by the Argentine Consulate or Embassy in the product's country of origin.


An Argentine importer/distributor must submit a registration application with the following information:


1) Legalized Certificate to Foreign Government (or Certificate of Free Sale)

2) Final Product Drawing

3) List of Components/Materials

4) Manufacturing Location

(...)

https://www.trade.gov/td/health/argentinaregs.html

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Note added at 5 mins (2017-10-20 21:28:50 GMT)
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https://books.google.com.ar/books?id=U8-fBwAAQBAJ&pg=PA106&l...