Skip to main content

Technovigilance Overview

Technovigilance (tecnovigilancia) is Mexico's mandatory post-market surveillance system for medical devices. It is the Mexican equivalent of EU vigilance reporting or FDA's Medical Device Reporting (MDR) system, and is governed by NOM-240-SSA1-2012 (with a significant update in draft as of 2024).

Purpose​

The goal of the technovigilance system is to ensure that medical devices remain safe and perform as intended throughout their lifecycle. It achieves this through:

  • Active monitoring of device performance in clinical use.
  • Systematic collection and assessment of adverse event reports.
  • Coordination of corrective and preventive actions when safety issues arise.
  • Sharing safety information across the supply chain and with COFEPRIS/CNFV.

CNFV — the national oversight body​

CNFV (Centro Nacional de Farmacovigilancia) is the COFEPRIS division responsible for:

  • Receiving adverse event reports for medical devices.
  • Assessing the severity, cause, and broader implications of incidents.
  • Coordinating with manufacturers, MRHs, and healthcare facilities on corrective actions.
  • Maintaining national technovigilance records.

All adverse event reports for medical devices are submitted directly to CNFV — not to COFEPRIS central.

Who must maintain a technovigilance unit?​

Under NOM-240-SSA1-2012 (and the draft 2024 revision), the following must establish a technovigilance unit:

  • The MRH (primary responsibility for the registered device)
  • Importers
  • Distributors (per the draft 2024 NOM update — a key change)
  • Healthcare facilities at state and national level

A technovigilance unit comprises:

  • Designated personnel with defined technovigilance responsibilities.
  • Documented procedures for incident detection, assessment, reporting, and escalation.
  • A system for receiving and processing complaints and adverse event notifications from the supply chain.

Technovigilance system components​

  1. Adverse event detection — monitoring device performance, receiving complaints and incident reports.
  2. Assessment — determining whether an event is a reportable serious adverse event or a non-serious incident.
  3. Reporting — submitting reports to CNFV within mandated timeframes.
  4. Trend reporting — identifying patterns across multiple incidents.
  5. Corrective action — implementing FSCAs when required.
  6. Documentation — maintaining a complete record for the Technovigilance Report at renewal.

Draft 2024 update — what is changing​

The PROY-NOM-240-SSA1-2024 draft (open for comment until September 2024) introduces several significant changes:

  • Expanded definitions — more stakeholders, including distributors, explicitly covered.
  • Distributor obligations — distributors now formally required to report incidents to the MRH within agreed timeframes (reflected in the technical agreement per NOM-241).
  • Clinical study report and quality management system added as defined concepts.
  • An Administrative Guide for Reporting Medical Device Incidents and Adverse Events is planned to complement the updated NOM.
Monitor publication

The draft NOM-240 update had not been formally published as of early 2026. Monitor the DOF and What's New for the finalisation date.