NOM-240-SSA1-2012 — Technovigilance
NOM-240-SSA1-2012 (Instalación y Operación de la Tecnovigilancia) establishes Mexico's mandatory technovigilance system for medical devices. It defines who must operate a technovigilance unit, what must be reported, and how.
Publication and status
- Published: 2012 in the Diario Oficial de la Federación.
- Status: In force. A significant draft update (PROY-NOM-240-SSA1-2024) was published for public comment, closing September 2024.
Scope
NOM-240 applies to:
- Mexico Registration Holders (primary responsibility).
- Importers and distributors.
- Healthcare facilities (hospitals, clinics, laboratories).
- State and national health authorities.
Key obligations under NOM-240
- Establish and maintain a technovigilance unit with trained personnel and documented procedures.
- Report serious adverse events to CNFV within defined timeframes.
- Submit trend reports for patterns of non-serious incidents.
- Coordinate FSCAs and notify CNFV when a corrective action is initiated.
- Submit a Technovigilance Report covering the full registration period as part of the 5-year renewal.
CNFV — the receiving body
Reports under NOM-240 are submitted to the CNFV (Centro Nacional de Farmacovigilancia), the COFEPRIS division responsible for adverse event assessment and national vigilance coordination.
Draft update — PROY-NOM-240-SSA1-2024
The 2024 draft introduces significant changes:
| Change | Detail |
|---|---|
| Expanded definitions | More stakeholders explicitly covered; new terms added (risk management, clinical study report, QMS, trend report) |
| Distributor obligations formalised | Distributors now explicitly required to report incidents to the MRH within agreed timeframes |
| Technical agreement interface | Distributor reporting obligations must be reflected in the technical agreement per NOM-241 |
| Administrative Guide | An administrative guide for reporting medical device incidents planned as a companion document |
Monitor DOF for finalisation
As of early 2026, PROY-NOM-240-SSA1-2024 had not been formally published as a final NOM. The comment period closed September 2024. Monitor the DOF and What's New for the publication date and transition provisions.
Access the official text
- DOF (dof.gob.mx) — search "NOM-240-SSA1-2012".
- COFEPRIS website — technovigilance section.