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 |
NOM-240 is under revision (PROY-NOM-240-SSA1-2024). Reporting timeframes may be updated in the finalised version. Always check against the current NOM-240 text and CNFV guidance.
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.