ANMAT medical device registration for FDA-cleared and CE-marked products entering Argentina. 62-day cap under Disposición 7516/2025 (published 42–62 day range). Single all-inclusive annual fee.
42–62 days (62-day cap under Disposición 7516/2025)
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.
First device family low-to-mid risk USD 7,500/yr, all-inclusive. Additional families +USD 3,500/yr.
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
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