ANMAT device registration in Argentina for FDA-cleared and CE-marked products, Classes I–IV via HELENA. One-time registration fee plus an annual holder fee.
Varies by device class (experience-based estimate, not a statutory cap)
In Argentina, whoever holds your ANMAT registration controls it. If a distributor holds it, they have commercial leverage over your imports. bioaccess® holds all Argentine registrations under its contract with you, working with our local partner in Argentina so you keep control of imports and can change distributors. We run Argentina as a fully integrated operation under your contract with bioaccess®, delivered through our local partner in Argentina: 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 (ANMAT Disp. 8194/2023, art. 6, https://servicios.infoleg.gob.ar/infolegInternet/anexos/390000-394999/390870/norma.htm) 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 as holder under the annual holder fee.
Two-part pricing for Argentina: a one-time registration fee of $4,500 (Class I), $6,500 (Class II) or $12,000 (Class III/IV), then an annual holder fee of $4,200 from year 2. The registration fee includes initial government fees and certified/sworn translations up to a stated cap, and the first 12 months of holder service; see /market-access#pricing for caps and exclusions. USD, excluding VAT and local taxes; valid for agreements signed by 31 March 2027. Argentina ENACOM RF homologation is not included and is quoted separately.
Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Related: Clinical trials in Argentina.