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 is stricter than most LATAM markets: the ANMAT registration holder is the sole importer of record, with no way to add secondary importers. If a distributor holds your ANMAT registration, they have permanent commercial leverage. bioaccess® holds all Argentine registrations through our own dedicated local entity so you keep control of imports and can change distributors. We run Argentina as a fully integrated operation through our integrated Argentine entity: establishment habilitation, a named Responsable Técnico, HELENA filings, ANMAT liaison, customs clearance as your importer of record, and tecnovigilancia — all under one roof. See the LATAM Importer of Record guide for the country-by-country rules.
Tecnovigilancia is not a PMS add-on. Argentina’s ANMAT registration holder must run post-market surveillance under Disposición ANMAT 8194/2023: incident reports within 48 hours for a serious public-health threat or 10 calendar days for death or serious deterioration, mandatory Field Safety Notices for corrective actions, and trend reports. If that system fails, ANMAT can prohibit the product nationwide, seize it, or cancel the authorization. A device without a live authorization cannot legally stay on the market. bioaccess® is the holder and runs that system on the USD 7,500 LATAM Launch Subscription.
The bioaccess® annual subscription includes ANMAT government submission fees, in-country registered agent, regulatory liaison, and sworn Spanish translation of IFU, labels, and technical file (Argentina requires sworn/official translations). Argentina ENACOM RF homologation for wireless devices runs through a separate authority and is billed 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.