Vigilance Reporting for Medical Devices in Mexico

Understanding technovigilance and adverse incident reporting

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.

Reporting adverse incidents for medical devices

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

Meeting COFEPRIS vigilance reporting requirements involves establishing reporting procedures according to Mexico requirements, timely communications with your Mexico Registration Holder regarding adverse incidents and related efforts.

Adverse incidents reporting guide for medical devices in Mexico

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.

Mexico medical device vigilance reporting system services

We assist medical device and IVD companies selling in Mexico and can act as their local authorized medical device representative to successfully address all of the medical device vigilance reporting needs, such as:

• 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 medical device companies looking to sell in Mexico with their vigilance and technovigilance reporting needs.

Medical device vigilance and technovigliance reporting FAQs

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.

Who is responsible for reporting adverse events in Mexico?

Medical device manufacturers and their Registration Holders are required to report adverse events to the Center for Pharmacovigilance (CNFV). Manufacturers and their in-country representatives must also report any efforts such as product recalls taken in response to adverse events.

What can cause an adverse event involving a medical device?

Issues including device malfunction, performance deterioration, inadequate instructions and/or inadequate labeling that could result in death or serious injury may be considered adverse events according to Mexican regulators.