Mexico’s Ministry of Health (COFEPRIS) requires medical device manufacturers to comply with a technovigilance system for post-market monitoring and adverse incidentreporting. The Mexican technovigilance system was launched in early 2013 and operates under the National Centre for Pharmacovigilance (CNFV).
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, as this document is only available in Spanish, speaking to your Mexico Registration Holder may also help clear up any confusion surrounding the vigilance system.
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 or Registration Holder is responsible for reporting adverse incidents to the 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 reporting 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.
- Inform your Registration Holder in Mexico and the CNFV that a reportable adverse incident has occurred, and if a recall is necessary.
- 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 extension (renewal) of the health record.
- Add all reports to your Quality Management System records.
Need help with Mexican vigilance reporting?
We represent more than 100 medical device and IVD companies as a Registration Holder, so we are very familiar with handling vigilance issues and incident reporting in Mexico. Working with Emergo 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 in-depth knowledge of the Mexican medical device market ensures that your vigilance procedures will always be up-to-date.
- Our experienced consultants can help you determine when incidents are reportable and that ensure that 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 office is staffed by Emergo employees who work closely with our other offices.
Please contact us for more information on how we can assist you with medical device vigilance reporting for Mexico