ANMAT Provision – No. 8799/2025
Health Department – Life Sciences Report | ANMAT Provision – No. 8799/2025
On November 28, 2025, Provision No. 8799/2025 (the “Provision“) was published in the Official Gazette, through which the National Administration of Drugs, Food and Medical Devices (the “ANMAT”), introduced an optional simplified health authorization regime for manufacturers and importers of low-risk medical devices. Those who opt for this regime would replace the traditional procedure regulated by Provisions 2319/02 (t.o. 2004), 7425/13 and its complementary 2096/22, with an affidavit.
The Provision applies exclusively to individuals or legal entities engaged in the manufacture and/or importation of medical devices of risk classes I and II and in vitro diagnostic medical devices (IVD) classified as A and B, while higher-risk medical devices (III and IV) and in vitro diagnostic medical devices (IVD) classified as C and D, they are still compulsorily subject to the traditional regime. This alternative seeks to streamline administrative procedures without relaxing health control standards.
The affidavit introduced by the Provision requires the data of the applicant (individual or legal entity) and the legal representative/attorney-in-fact, data of the establishment (processing plant and/or warehouse) and the responsible professional, supporting documentation on the property, authorizations, contracts, controlled areas and corporate records, and declarations of compliance with Good Manufacturing Practices -GMP- (approved by Provision 3266/13), veracity of the information and commitment to keep it updated. Regarding GMP, those who submit the affidavit will be subject to regular inspections aimed at verifying compliance with the applicable regulations in force according to the activity carried out.
The Provision establishes that the affidavit submitted will not have an expiration period, but requires that any relevant modification – such as changes of legal or industrial domicile, expansion or modification of activities, incorporation of new warehouses or plants, or changes in the technical direction – be communicated to ANMAT by means of a new affidavit within thirty days of the change.
Failure to comply with this obligation or falsehood in the data declared may result in sanctions according to Law 16,463, including suspensions, summary proceedings and eventual criminal or civil liability.
Likewise, the Provision establishes that companies that already have an authorization or its modification in progress may not submit the new affidavit until the requirements of the current procedure are completed; once complied with, they will be notified to opt for the new regime, and if they also submit the declaration, their current files will be considered closed, except for those that include excepted activities (risk class III and IV, and those of in vitro use diagnosis C and D). In addition, it is provided that all the procedures included in the new regulations are subject to the payment of the current fees set by Provision DI-2025-4058 or the one that replaces it.
The Provision will enter into force 60 administrative working days following its publication.
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