Adverse Event Reporting
Under NOM-240-SSA1-2012, the Mexico Registration Holder (MRH) is responsible for reporting adverse events related to registered medical devices to CNFV (Centro Nacional de Farmacovigilancia) within defined timeframes.
What must be reported
The following must be reported to CNFV:
- Serious adverse events — incidents involving death, life-threatening illness/injury, hospitalisation, permanent impairment, or medical/surgical intervention to prevent such outcomes.
- Device malfunctions that could cause or contribute to a serious adverse event if the malfunction were to recur.
- Non-serious incidents — tracked and included in the Technovigilance Report at renewal, but not always requiring immediate individual reports.
Also reportable:
- Trend patterns — clusters of non-serious incidents that individually may not be reportable but collectively indicate a systemic safety issue.
- Field Safety Corrective Actions (FSCAs) — COFEPRIS/CNFV must be notified when an FSCA is initiated.
Reporting timeframes
| Event type | Reporting timeframe |
|---|---|
| Serious adverse events — death or serious deterioration | As soon as practicable; generally within 10 calendar days of becoming aware |
| Serious adverse events — other | Within 30 calendar days |
| Trend reports | Per schedule agreed with CNFV or as specified in NOM-240 |
The timeframes above reflect NOM-240-SSA1-2012 (current). A draft update (PROY-NOM-240-SSA1-2024) was under consultation as of early 2025. Once finalised, timeframes may change. Check the DOF and CNFV website for the final version before implementing any changes to your reporting procedures.
Who submits to CNFV?
The MRH submits adverse event reports to CNFV, typically on behalf of the foreign manufacturer. The report flow:
Healthcare facility / Patient / User
↓ (incident detected)
Distributor
↓ (notifies MRH per technical agreement)
MRH (technovigilance unit)
↓ (assesses and reports)
CNFV (within mandated timeframe)
Note: Healthcare users and facilities can also directly notify CNFV of device-related incidents. In this case, CNFV will contact the MRH for follow-up.
How to submit reports
Reports are submitted to CNFV through:
- The COFEPRIS/CNFV technovigilance reporting system.
- The Administrative Guide for Reporting Medical Device Incidents and Adverse Events (in preparation as of 2024–2025 — monitor CNFV for publication).
Reports should include:
- Device identification (registration number, homoclave, model/catalogue number).
- Event description — what happened, when, where, outcome.
- Patient information (anonymised).
- Manufacturer and MRH details.
- Initial assessment of device involvement.
Follow-up reports
For serious events, CNFV may request follow-up reports with additional information once the root cause investigation is complete. The investigation and corrective action should be documented in the technovigilance record.
Technovigilance Report at renewal
All adverse incidents reported during the 5-year registration period must be summarised in the Technovigilance Report, submitted to COFEPRIS as part of the registration renewal application. The report must include:
- Counts and descriptions of serious and non-serious incidents.
- Annual units sold and estimated patient exposure.
- Any safety alerts or FSCAs taken.
- Summary of corrective actions.
Related pages
Who submits to CNFV?
Handling direct reports from healthcare facilities Healthcare users and facilities can report device incidents directly to CNFV without notifying the MRH first. When this occurs:
CNFV will contact the MRH to request an initial assessment and any available information about the device, manufacturer, and incident context. The MRH should respond to CNFV within 10 calendar days with available information, even if the full investigation is incomplete. Consider this direct reporting pathway when designing your distributor technical agreement — distributors should be contractually required to monitor CNFV communications and alert the MRH if direct reports are received. To reduce gaps, encourage major customers and distributors to notify you promptly when they become aware of incidents, even if they have also reported directly to CNFV.