Medical Device Registration - Mexico Updates

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. 

WHAT YOU WILL LEARN: 

  • 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
  • And much more 

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 Solutions, performing regular medical device classifications and grouping assessments, peer reviewing applications submitted within the country service catalog.

This webinar was recorded on July 21, 2022.