By virtue of ANMAT Provision No. 224/2026, published on January 30, 2026, the National Agency of Medicines, Food and Medical Technology (ANMAT) updated the procedure applicable to the importation of used medical devices, within the framework of the amendments introduced by Decree No. 273/2025, which reformed the general regime for the importation of used goods.
The Provision applies to refurbishment, restoration, reconstitution and/or functional verification activities of used medical devices, provided that such activities allow restoring the devices to the manufacturer’s original specifications or to new specifications conceived by the manufacturer, without modifying their intended use, original application or the essential requirements of safety and effectiveness. It is expressly clarified that technical service or maintenance activities are excluded from the scope of the regime.
The Provision sets forth those medical devices holding a valid registration before ANMAT, excluding those labeled for ‘single use’, may be imported, if they are not included in Annex II of former Resolution No. 909/94 issued by the former Ministry of Economy and Public Works and Services. Devices may be imported as refurbished abroad, as used devices not requiring refurbishment, or as used devices intended to be refurbished in the Argentine Republic.
Imports may be carried out either by the end users of the products or by authorized facilities entitled to perform importation, manufacturing and/or refurbishment activities of medical devices, in accordance with ANMAT Provision No. 2319/02 (T.O. 2004) and the regulations applicable to the relevant risk class
As regards the procedure, the Provision differentiates according to the risk class of the medical device. For Class I and II medical devices, an Import Notice, filed as an affidavit, must be submitted within forty-eight (48) hours following customs clearance. For Class III and IV medical devices, the requirement to obtain prior import authorization under the applicable procedure remains in force.
In addition, the Provision details the supporting documentation that, in the cases and under the conditions determined by ANMAT, must accompany the Import Notice or the application for authorization, depending on the risk class of the device and the modality of importation.
Finally, the Provision expressly repeals ANMAT Provision No. 806/2007 and provides that it shall enter into force forty‑five (45) business days following its publication in the Official Gazette.
