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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 2025. Check the DOF regularly for the final version. Monitor the DOF and What's New for the finalisation date.

Who must maintain a technovigilance unit?​

Technovigilance unit structure & qualifications ​ While NOM-240 does not mandate specific staffing levels, best practice and COFEPRIS expectations include:

A dedicated technovigilance coordinator (full-time or part-time depending on device portfolio size) responsible for day-to-day operations. A senior manager (often the Responsable Sanitario or quality manager) accountable for escalation and regulatory decisions. Access to medical or technical expertise for assessing device involvement in reported events. Personnel must receive documented training on:

NOM-240 requirements and CNFV reporting procedures. Your device's intended use, known risks, and contraindications. Incident assessment methodology and severity classification. FSCA decision-making and Field Safety Notice preparation. REQUEST evidence of technovigilance training during COFEPRIS inspections. Document all training records and maintain them for at least 5 years.