Argentina Healthcare

All imports of medical products must be carried out by an importer registered with the Argentine food, drug, and medical equipment regulatory agency, ANMAT, the Argentine equivalent of the U.S. FDA.  Working with an appointed importer/distributor is key to process registration.  Please contact the U.S. Commercial Service for assistance in identifying potential distributors.

Product registration classification encompasses classes I, II, III, and IV.  Documentation varies by product and ANMAT evaluator requirements.  Many include:

•    FDA certificate (Certificate to Foreign Government) with an apostille seal,
•    Letter or certificate of representation/distribution, in Spanish, with an apostille seal,
•    Letter of commitment with an apostille seal from the manufacturer committing to report any recalls/withdrawals and/or safety actions taken related to the product to the local importer who markets the product, 
•    Marketing history record, including a list of countries where the product is sold, any adverse effects, recalls/market withdrawals related to the product, and where applicable, measures/corrective actions that were taken, indicating the date up to which the marketing history record was updated,
•    Users or technical manual and brochures and labels, in Spanish,
•    Essential requirements (ER) matrix, and
•    Detailed description of the product, its packaging, and manufacturing flowchart process.

This list serves as an example.  Required documents vary depending on the specific product.  Additional resources (in Spanish) can be found here: ANMAT | Argentina.gob.ar 

For additional information on the healthcare sector in Argentina, please contact Commercial Service Argentina’s Commercial Specialist Liliana Paz