Allende & Brea – Estudio Jurídico

This report cannot be considered as legal or any other kind of advice by Allende & Brea. For any questions, do not hesitate to contact us.

New ANMAT Regulation on Medical Devices and In Vitro Diagnostic Medical Devices

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. 07/24, which approved the Mercosur Technical Regulation on essential safety and performance requirements for Medical Devices and In Vitro Diagnostic Medical Devices.

GMC Resolution No. 07/24 updated the essential safety and performance requirements for Medical Devices and In Vitro Diagnostic Medical Devices. The new Technical Regulation reviews the general principles of safety and performance applicable to both types of products and establishes differentiated requirements, including those common to both, those specific to Medical Devices, and those exclusively for In Vitro Diagnostic Devices.

Consequently, with the incorporation of this Resolution, ANMAT Disposition No. 4306/99, which had incorporated the previous Mercosur GMC Resolution No. 72/98 on essential safety and efficacy requirements for Medical Devices, was repealed.

This report cannot be considered as legal or any other kind of advice by Allende & Brea. For any questions, do not hesitate to contact us.

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