By virtue of Provision No. 2857/2025 issued by the National Administration of Drugs, Food and Medical Technology (ANMAT), published in the Official Gazette on May 5, the requirements prescribed by current regulations have been simplified in order to facilitate access to non-prescription medical devices.
Non-Prescription Medical Devices
The Provision establishes that ANMAT shall not intervene in the import procedures of non-prescription medical devices acquired by natural persons, provided that such devices are intended for personal use.
Non-prescription medical devices are those which, by virtue of their intrinsic nature and intended use, may be employed directly by the patient or end user.
The imported medical devices and their subsequent use shall remain under the exclusive responsibility of the user, who shall assume all risks and potential effects arising from their acquisition.
Prohibition
The commercialization, use for profit, or free distribution of the medical devices subject to this Provision is expressly prohibited.
Implementation
The National Institute of Medical Products shall prepare a guidance document listing the devices covered under Provision No. 2857/2025, which shall be updated periodically.
