On November 28, 2025, Provision No. 8799/2025 of the NATIONAL ADMINISTRATION OF MEDICINES, FOOD, AND MEDICAL TECHNOLOGY (hereinafter, “Provision 8799/25”) was published in the Official Gazette, establishing a national health authorization regime based on the submission of an affidavit for individuals and legal entities engaged in the manufacture and/or importation of risk class I and II medical devices and in vitro diagnostic medical devices (IVDs) classified as A and B. The measure was issued within the framework of Law No. 16,463, Decree No. 1490/92, and ANMAT Provisions Nos. 2319/02 (t.o. 2004), 3266/13, 7425/13, 2096/22, 64/25, and 2198/22, among other applicable regulations.
Access the complete text of the Provision and its annex here.
Agustín Siboldi – SiboldiA@eof.com.ar
Jorge Muratorio – MuratorioJ@eof.com.ar