COFEPRIS Medical Device Adverse Event Report

COFEPRIS Medical Device Adverse Event Report Form

This COFEPRIS Medical Device Adverse Event Report Form is designed to help healthcare facilities, medical professionals, and manufacturers in Mexico efficiently report adverse events involving medical devices to the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).

Under Mexican regulatory requirements, any serious adverse event or malfunction of a medical device must be reported to COFEPRIS to ensure patient safety and maintain regulatory compliance. This form streamlines the reporting process by capturing all essential information including incident descriptions, patient outcomes, device identification, and manufacturer notification details in one comprehensive submission.

Who should use this form?

This template is ideal for:

• Healthcare facilities and hospitals managing medical device safety programs
• Medical professionals who encounter device-related adverse events
• Medical device manufacturers and distributors operating in Mexico
• Quality assurance teams responsible for regulatory compliance
• Clinical risk managers overseeing patient safety initiatives

Key features of this form

The form captures critical information required by COFEPRIS regulations, including detailed incident descriptions, patient impact assessment, complete device identification (including registration numbers and batch details), manufacturer information, and corrective actions taken. The structured format ensures consistent reporting and helps maintain compliance with NOM-240-SSA1-2012 and other relevant Mexican health regulations.

With Paperform's conditional logic, the form adapts based on event severity and patient outcomes, ensuring appropriate follow-up information is collected. Integration capabilities allow you to automatically route urgent reports to regulatory affairs teams, sync data with quality management systems, and maintain comprehensive audit trails.

For organizations managing multiple facilities or device portfolios, Stepper can automate the entire post-submission workflow—triggering manufacturer notifications, creating investigation tasks, generating timeline reports for COFEPRIS submission, and keeping all stakeholders informed throughout the resolution process.

This professional, compliant form helps Mexican healthcare organizations meet their regulatory obligations while protecting patient safety and maintaining transparent communication with COFEPRIS authorities.