Through Disposition No. 11419/2024, the National Administration of Drugs, Food, and Medical Technology (ANMAT) incorporated into the national legal framework the Mercosur Common Market Group (GMC) Resolution No. 20/17 concerning procedures for the inspection of manufacturers of Medical Devices and In Vitro Diagnostic Products, along with its amendments introduced by GMC Resolution N°34/23.
GMC Resolution No. 20/17 updated the common procedures for conducting health inspections of manufacturers of Medical Devices and In Vitro Diagnostic Products, based on the experience gained through joint actions within the Mercosur framework.
Consequently, with the incorporation of these Resolutions, ANMAT Disposition No. 3265/13, which had incorporated the earlier Mercosur GMC Resolution No. 32/12 on common procedures for inspecting manufacturers of Medical Devices and In Vitro Diagnostic Products in the Member States, was repealed.
