Technovigilance, or Medical Device Surveillance, is the activity that ensures that any medical technology in Mexico is correctly working and describes how to report any incident related to the device.
In this article, we summarize the technovigilance requirements in Mexico, including:
- How to identify an adverse incident
- When to report and when not to report an incident
- Responsible entities and reporting timelines
- Recent institutional changes in technovigilance authorities
Legal Framework
The Mexican Official Standard for technovigilance is the NOM-240-SSA-2012 which establishes the requirements for installing, operating, and maintaining a technovigilance system in Mexico.
This standard is aligned with other national and international regulations related to medical device post-market surveillance and vigilance systems.
NOM-240-SSA-2012 applies exclusively to incidents that occur within Mexican territory. However, when an incident is reported in Mexico, the authority must also be informed about any corrective or preventive actions implemented both locally and in other countries, when applicable.
Recent Institutional Update
Following the Decree that reforms the General Health Law published on January 15 and as communicated by COFEPRIS, the National Center of Pharmacovigilance (CNFV) has evolved into the National Center for Pharmacovigilance and Technovigilance (CENAFyT).
This institutional evolution reflects the growing importance of technovigilance and medical devices within Mexico’s health surveillance system, formally integrating pharmacovigilance and technovigilance activities under a single, strengthened authority.
Key Definitions
The following definitions are essential for understanding technovigilance requirements in Mexico. For additional terms, we suggest checking the norm or feel free to get in touch with us.
- Incident: any event related to a medical device.
- Adverse Incident: any event related to a medical device, caused by a malfunction and that could lead to death or health deterioration.
- CENAFyT: The National Center for Pharmacovigilance and Technovigilance, the authority responsible for receiving, assessing, and monitoring reported adverse incidents related to medicines and medical devices in Mexico.
- Notification: the act of informing CENAFyT about the occurrence of an incident. Notifications may be initial, follow-up, or final.
When to report and when not to report an incident
We have defined an adverse incident and an incident, but it is still a vague description to identify when to get in contact with the authorities. Therefore, we provide a summary of when to report and not to report an incident:
You need to report an incident in case any of the following 3 points prevails:
Point 1
- It is related to a malfunction that caused the adverse incident.
- It is an unpredicted adverse incident. In other words, an adverse incident not identified by the manufacturer during the risk evaluation.
- Labels or manuals provide inaccurate information that caused the adverse incident.
- The medical device has interactions with other products or substances that lead to the adverse incident.
- There are False Positives or Negatives in Diagnostic devices that lead to the adverse incident.
Point 2
- The incident is related to the medical device.
Point 3
- The incident caused or could cause patient death or important health deterioration.
You do not need to report an incident when:
- The malfunction was detected prior the device usage. In the meantime, the malfunction would not cause death or important health deterioration.
- When the patient condition was the real cause of the event.
- Expired devices were used.
Responsible parties
A surveillance program is part of any entity or party related to the medical device. Even patients, nurses and physicians are encouraged to report an incident. Nevertheless, the norm clearly states that the sanitary registration holder as the local representant of the device manufacturer, is the main responsible of handling the technovigilance program in Mexico.
In other words, any manufacturer outside in Mexico who has registered his products in Mexico, must be sure who acts as its Mexican Registration Holder in order to request any feedback related to incidents in Mexico or even worldwide. You can check more details about your specific role in our guides.
Timelines to notify an event
As a result of the efforts of the MoH (Ministry of Health) to make the Technovigilance accessible and for more people, any notification can be performed online via the COFEPRIS webpage. The sanitary registration holder must notify adverse incidents within the following timelines:
- Public health threat: within 2 working days
- Death or serious health deterioration: within 10 calendar days
- Any other adverse incident: within 30 calendar days
Frequently asked questions (FAQ)
- What is technovigilance in Mexico? Technovigilance is the post-market surveillance system that monitors the safety and performance of medical devices used in Mexico. Its purpose is to detect, evaluate, and prevent adverse incidents that could affect patient safety or public health.
- What authority receives technovigilance reports?
As of March 2024, technovigilance reports are evaluated by CENAFyT (National Center for Pharmacovigilance and Technovigilance), following its evolution from the former CNFV.
- Does the change from CNFV to CENAFyT affect technovigilance obligations?
In practice, no.The reporting obligations, timelines, and responsibilities established in NOM-240-SSA-2012 remain unchanged. The institutional change mainly seeks to strengthen and modernize the surveillance framework, with a strong focus on updating the NOM-240 Technovigilance Standard in the future.
Conclusion
We have identified when to report and when not to report incidents, timelines and responsible parties in Mexico. Nevertheless, the authority encourages to promote the pro notification criteria in cases it is not clear to report or not.
Although not discussed in this article, even if no incidents are reported during a 5 year period, it is still necessary to present a Technovigilance report to the authorities, as a requirement of the extension of the registration. You can find more details in our Regulatory Guide.
Please, contact us at [email protected] to know more about this topic or any other question you may have about the sanitary regulation in Mexico. You can also check our guidelines with more details about the regulatory process in Mexico.