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Argentina medical device government fees

Row-level verified

ANMAT current fee schedule, reviewed for 2026, in ARS.

6 fee lines100% exact amountscurrency ARSFX rates 2026-09-16reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Registration - Class I/II familyARS 500,220$332Per applicationVerified
Registration - Class III/IV familyARS 824,985$548Per applicationVerified
IVD Registration - Class A/BARS 445,725$296Per applicationVerified
IVD Registration - Class C/DARS 564,165$374Per applicationVerified
Manufacturer/importer authorization including GMP and technical directorARS 1,880,550$1,248Per authorizationVerified
Foreign plant GMP verification
Travel and additional-plant charges are separate.
ARS 11,799,000 + travel$7,831Per main plantVerified
Government fees only — service and testing costs are separate
  • Official Annex II to Disposition 2978/2026; effective 1 June 2026.
  • Fees can be inflation-adjusted by a later ANMAT disposition, so use the linked tariff before payment.
  • Registrations also carry an annual maintenance charge (tasa anual): the last published maintenance tariff (Disposición ANMAT 5634/2024, 2023 period) was ARS 39,500/52,000/70,000/93,000 per Class I/II/III/IV for marketed devices and ARS 45,500/64,000/81,500/118,500 for not-marketed devices; the current maintenance amounts sit in the 2978/2026 annexes and supersede those figures.
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Exact amounts verified against the ANMAT fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:argentina:registration-class-i-ii-family