Argentina Caps ANMAT Medical Device Import Fees at ARS 5 Million

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) published Disposición Nº 5461/2026 (DI-2026-5461-APN-ANMAT#MS) on 28 August 2026. Article 3 makes the final administrative disposition effective on 1 September 2026 and applies the new fee rules to proceedings initiated on or after that date.

For medical products, the material change is narrow but potentially significant: the new Anexo II caps ANMAT's fee for an import-clearance intervention at ARS 5,000,000. It does not raise the percentage rates or the ARS 55,000,000 tier threshold.

How the ARS 5 million cap works

Section J of Anexo II lists the fee for ANMAT's intervention in the customs clearance of an imported medical product (intervención de despacho a plaza de producto importado):

The previous medical-product schedule, Anexo II to Disposición 2978/2026, used the same threshold and percentage rates but did not state a cap. ANMAT's official explanation likewise says that the percentages and tiers remain in place and the new ceilings apply where relevant.

Pure Global calculation: in the upper tier, 1.25% of ARS 400,000,000 is ARS 5,000,000. The cap therefore changes the calculated fee only when the FOB amount exceeds ARS 400,000,000.

These are schedule calculations, not quotations or estimates of a particular shipment invoice.

What did not change in the medical-product schedule

Pure Global compared every line of the May and August medical-product annexes. After normalizing the different thousands and decimal punctuation, the fixed medical-device and in vitro diagnostic (IVD) amounts are numerically unchanged. Representative examples are:

Disposición 5461/2026 Article 2 separately repeals Anexo IV of Disposición 2978/2026. That old Anexo IV covered food products and food establishments; it was not the medical-device and IVD fee table. The medical-product comparison is between the two documents' respective Anexo II files.

The cap does not create a new import-intervention requirement

The cap applies to the tariffed ANMAT intervention listed in Anexo II; it does not expand the shipments that require that intervention. Disposición 4446/2025 had already removed ANMAT's prior import-authorization intervention for registered Class I and II medical products imported by authorized establishments for commercialization or free distribution. ANMAT's implementation notice describes the replacement post-import notice as non-tariffed.

Companies should therefore determine the applicable import route before applying the cap. A shipment handled through a non-tariffed notice is not converted into a tariffed clearance merely because Disposición 5461/2026 introduced a ceiling for other interventions.

What manufacturers and importers should do

1. Update calculations for proceedings initiated on or after 1 September 2026. For a tariffed medical-product import intervention in the upper tier, use the lower of 1.25% of FOB value and ARS 5,000,000.
2. Do not change fixed device and IVD fee budgets solely because Anexo II was reissued. The listed amounts match the May 2026 medical-product annex numerically.
3. Separate the import route from the fee calculation. Confirm whether the shipment requires an ANMAT intervention or follows a non-tariffed notice route before calculating a clearance fee.
4. Retain the applicable annex with the filing record. The initiation date controls whether the new ceiling applies, and the disposition provides no separate transition rule for proceedings started before 1 September.

The controlling sources are the official disposition, its medical-product Anexo II, and ANMAT's implementation summary. For broader market-access context, see Pure Global's Argentina market page.