ANSWERED ON THIS PAGE:
- What is technovigilance and why is it important?
- When do we need to file an adverse incident report?
- What is the technovigilance reporting process?
Part of Mexico's Ministry of Health, the Federal Commission for Protection from Sanitary Risks (COFEPRIS) requires medical device manufacturers to comply with a technovigilance system for post-market monitoring and adverse incident reporting. Technovigilance is designed to verify that approved medical devices function in accordance with the manufacturer’s intended use, which is outlined on the medical device approval issued by the Ministry of Health.
When are adverse incident reports required?
An adverse incident must be reported if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death or serious injury, or could lead to death or serious injury if it were to recur.
The device manufacturer and Registration Holder are responsible for reporting adverse incidents to the National Center for Pharmacovigilance (CNFV), which must also be notified if any action is taken to reduce the risk of death or serious deterioration in health, such as a recall.
Mexico medical device vigilance reporting process
Shown below are the basic steps you should follow in managing an adverse incident in Mexico:
- Reference Mexican Standard NOM-240-SSA1-2012 for the correct reporting timeline, which will depend on the severity of the incident. Update your vigilance reporting procedures with Mexico requirements.
- • Inform the CNFV through your Registration Holder in Mexico that a reportable adverse incident has occurred, and whether a recall is necessary.
- If an adverse incident is not reported, provide your Registration Holder with justification for the decision, which would be shown to COFEPRIS in case of an audit.
- Submit monitoring and final reports within six months of a reportable incident, unless an extension is granted by the CNFV.
- Perform technovigilance reports every five years as part of the renewal of the registration process.
- Add all reports to your Quality Management System records.
Need help with vigilance reporting in Mexico?
We represent more than 100 medical device and IVD companies as a Registration Holder, giving us a high degree of familiarity with handling vigilance issues and incident reporting in Mexico. Working with Emergo by UL offers you the following benefits:
- If we act as your Registration Holder, we can submit adverse incident reports and recall information to the CNFV on your behalf.
- Our experienced consultants can help you determine when incidents are reportable and ensure your final incident reports are completed on time.
- We have experience assisting hundreds of manufacturers with post-market surveillance, COFEPRIS registration, and other regulatory consulting services.
- We offer consistent, reliable service. Our Mexico City office is staffed by Emergo employees who work closely with our other offices.
Emergo by UL is an experienced, full-service medical device consulting firm with offices in Mexico City and around the world. Our team is here to help you succeed in Mexico.
Frequently asked questions
How can we learn and implement specific technovigilance requirements?
Mexican Standard NOM-240-SSA1-2012 offers valuable information on terminology, timelines, and other technovigilance reporting requirements, including the requirements for the renewal process related to technovigilance. However, speaking to your Mexico Registration Holder may also help clear up any confusion surrounding the vigilance system. Emergo can also provide NOM 240 and NOM 241 Awareness Training for your employees.
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