Through Disposition No. 64/2025, the National Administration of Medicines, Food and Medical Technology (ANMAT) incorporated GMC Resolution No. 25/21 (the “Resolution”) into the national legal framework. The Resolution established the “MERCOSUR Technical Regulations for the Registration of Medical Devices” (the “RTM”).
The Resolution updated the registration criteria for medical devices within MERCOSUR member states. It also outlines the classification criteria for medical devices and their accessories, as well as the minimum general requirements for their registration. Used or refurbished medical devices, as well as medical devices for in vitro diagnostics, are excluded from the scope of the Resolution.
As a result of adopting this Resolution, ANMAT Disposition No. 2318/02 and ANMAT Disposition No. 1285/04 were repealed. The latter had previously incorporated the earlier MERCOSUR GMC Resolution No. 40/00 regarding the prior RTM.
