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 is responsible for reporting adverse events to COFEPRIS? - What are the specific reporting deadlines for serious and non-serious incidents? - How does post-market surveillance impact the 5-year renewal of your sanitary registration? - What is the function of a Mexico Registration Holder (MRH) in the Technovigilance process? - What key changes are introduced in the draft PROY-NOM-240-SSA1-2024? - Will Software as a Medical Device (SaMD) be covered under the new Technovigilance rules? - What are the core components of a compliant Technovigilance unit? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Mexico, managing your registration and Technovigilance obligations. Our experts develop efficient regulatory strategies and use advanced AI to compile technical dossiers, ensuring compliance with bodies like COFEPRIS. Let us help you maintain your market presence with continuous regulatory monitoring and post-market surveillance support. For a seamless path to market, contact us at [email protected], visit our website at https://pureglobal.com, or explore our free AI tools at https://pureglobal.ai.