On 28 August 2026, Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) officially issued Notice No. 5461/2026, updating the administrative procedures and fee schedules for medical devices. The most closely watched change for businesses is the introduction of a maximum cap of ARS 5 million on ANMAT import fees for medical devices. The new rule takes effect on 1 September 2026.
The full 2026 ANMAT Medical Device Fee Schedule is included at the end of this article.
Original source: https://www.boletinoficial.gob.ar/detalleAviso/primera/346535/20260828
I. New Cap Introduced for Medical Device Import Fees
According to Annex II of the notice, where ANMAT intervention is required for customs clearance and release of imported medical devices, fees continue to be calculated in tiers based on the FOB value of the imported goods:
| FOB Value of Imported Medical Devices | Fee |
|---|---|
| Below ARS 55,000,000 | 1.5% of FOB value |
| Equal to or above ARS 55,000,000 | 1.25% of FOB value, capped at ARS 55,000,000 |
Under the 1.25% rate, the fee reaches the ARS 5 million cap once the FOB value of the imported goods reaches ARS 400 million. Beyond that threshold, the fee will in principle not exceed ARS 5 million, regardless of how much higher the import value rises.
Example: For goods with an FOB value of ARS 600 million, the previous rule would have required a payment of ARS 7.5 million (calculated at 1.25%). Under the new rule, the actual fee is capped at ARS 5 million—a saving of ARS 2.5 million. This adjustment will therefore significantly reduce regulatory costs for large-value medical device imports.
II. Not All Medical Device Imports Are Subject to This Fee
Argentina’s medical device import fee applies only to import operations that require ANMAT intervention for customs clearance and release. Imports of Class I and Class II medical devices that comply with the provisions of Regulation No. 4446/2025 do not require prior ANMAT intervention and, in principle, are not subject to this FOB-based fee. For Class III, Class IV and IVD products, applicability must be confirmed on a case-by-case basis according to the specific import procedure.
III. Recommendations for Medical Device Companies
Companies planning to enter the Argentine market should recalculate project costs in light of their product classification, import model and FOB value. For high-value equipment or large-volume import operations, it is worth assessing in detail the cost reductions offered by the new cap mechanism. For Class I and Class II products, the first step should be to confirm whether the policy exempting them from prior import intervention applies.
IV. Medical Device Fee Schedule (2026)
A line-by-line comparison with the previous Regulation No. 2978/2026 confirms that the fixed official fees for medical device registration, changes, establishment licensing and overseas GMP remain unchanged.
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