Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is responsible for the review, approval, and post-market monitoring of any healthcare product in Mexico. However, regulatory requirements are complex, and it can be difficult to identify the most efficient submission route for your products. In this complimentary webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes.
July 21, 2022
Nélyda Georgina González Lara, lead quality & regulatory affairs consultant for Mexico, Peru and Costa Rica services at Emergo by UL
This webinar examines current medical device registration requirements in Mexico and recent regulatory changes.
- Regulatory structure in Mexico
- Overview of key medical device laws and regulations
- Medical device and IVD classification schemes and registration pathways
- Testing and clinical data requirements
- Quality management system and in-country representation requirements
- Main market challenges
About the presenter:
Nélyda Georgina González Lara
Nélyda González Laura has been working in regulatory consulting companies almost 10 years, focusing on medical devices and consumer products regulation in Mexico. Her experience includes regulatory consulting, regulatory compliance, post market surveillance and vigilance Mexican Standards, as well as preparation of over 200 successfully approved submissions including Health Registrations, Modifications, Renewals for different categories and risk class for Latin-American markets.
González Lara is currently a Lead Quality & Regulatory Affairs Consultant for Mexico, Peru and Costa Rica services at Emergo by UL, performing regular medical device classifications and grouping assessments, peer reviewing applications submitted within the country service catalog.