Post-Market Overview
Overview of ongoing post-market obligations for medical devices in Mexico — technovigilance, FSCAs, labelling, and registration renewal.
Technovigilance Overview
Mexico's technovigilance system under NOM-240-SSA1-2012 — what it is, who is responsible, and what it requires for medical device post-market surveillance.
Adverse Event Reporting
What adverse events must be reported to Mexico's CNFV, who must report, reporting timeframes, and how to submit reports under NOM-240.
FSCAs & Recalls
Field Safety Corrective Actions (FSCAs) and recalls in Mexico — when required, how to notify COFEPRIS/CNFV, and Field Safety Notice requirements.
Registration Renewal
How to renew a COFEPRIS medical device sanitary registration — 5-year renewal cycle, first vs subsequent renewals, extended 10-year renewals from 2026, and required documentation.
Labelling — NOM-137
Medical device labelling requirements in Mexico under NOM-137-SSA1-2008, Spanish-language obligations, and the 2024 draft update.