ANMAT medical device registration for FDA-cleared and CE-marked products entering Argentina. Risk-based classification (Classes I–IV) under Disposición 2318/2002; lower-risk classes file via a sworn declaration through the ANMAT HELENA electronic platform. Single all-inclusive annual fee.
Varies by device class (experience-based estimate, not a statutory cap)
Argentina allows only ONE importer of record per ANMAT registration — there is no way to add secondary importers. bioaccess® holds the registration through our own Argentine entity.
All-inclusive annual subscription per country; pricing under review — contact us for a quote.
All-inclusive annual subscription includes government submission fees, in-country registered agent, regulatory liaison, and certified/sworn translations where required. Electrical/EMC and RF homologation for wireless devices are handled through the country’s telecom authority at vendor cost plus a 20% G&A handling fee.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Argentina.