ANMAT medical device registration for FDA-cleared and CE-marked products in Argentina. In-country holder. Classes I–IV via HELENA. 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.
Market Access Essentials / LATAM Launch Subscription: USD 7,500 per year per country for the first device family. Includes government submission fees, sworn translations, in-country titular/RH/IOR, and tecnovigilancia as holder. Additional families quoted on request.
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.