Argentina Medical Products Import Update

The Argentine Bureau of Medicines, Foods and Medical Technology (ANMAT), equivalent to the U.S. Food and Drug Administration, has the responsibility of ensuring that health products, medicines, food, and medical technology are effective, safe, and of high quality. 

Consistent with the Government of Argentina’s policy to simplify administrative processes and offer a more dynamic trade framework, ANMAT has issued a regulation (Disposición 4446/25) that streamlines the importation of low-risk medical products for commercial use.

As of August 6, 2025, registered and authorized importers of Class I & II medical products (thermometers, lens disinfectants, sterile syringes, needles, blood pressure monitors, bandages, gauze, etc.) will not be required to receive authorization for each import transaction, as had previously been the case. Importers must simply provide notification by issuing a sworn statement through an online platform within 48 hours of the products entering the country. Products must be previously registered in accordance with the regulations applicable to each category.

According to industry sources, this measure affects approximately 70 percent of all medical products imported into Argentina, representing a significant change in terms of operational agility and regulatory efficiency.

For additional information, including market analysis, trade events, and U.S. Commercial Service offerings, please contact Commercial Service Argentina at Office.BuenosAires@trade.gov.