Latest / Medical Device Global Market Access
Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration renewal. We also discuss the significant updates proposed in the draft 2024 version of the standard, which will impact software devices and distributor obligations. - What is Technovigilance and why is it mandatory for medical devices in Mexico? - Who…
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