Any company that wants to manufacture or import medical devices in Argentina must have a Quality Management System in compliance with ANMAT’s GMP. The GMP is instituted in ANMAT’s Disposition 191/99. After implementation of the GMPs, the manufacturer or the importer must go through an inspection as part of the Authorization of facilities process. Compliance with ISO 13485 and/or FDA QSR does not imply compliance with ANMAT GMP.

For manufacturers residing outside of Argentina, the following two situations are possible depending on the origin of the products:

1. If the manufacturer of the products is located in a High Sanitary Surveillance country/region (Australia, Canada, Swiss, and EU Members states, USA, Israel and Japan) or if the products have sales clearances in any of these countries/regions then the GMP requirement is only applicable to the Argentinean importer.
   
   OR else
    
2. Both the Argentinean importer and the manufacturer must comply with GMPs and go through an inspection from ANMAT.

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