WATCH NOW: Medical Device Registration in Mexico


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 free 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 
• And much more 

ABOUT THE PRESENTER: 
Ann Marie Boullie has over 10 years of experience in the medical device industry, with expertise in regulatory requirements and strategy in major Latin American and Asian markets. As Global Operations Manager, Ann Marie oversees Emergo’s project management team worldwide, and has operational oversite for offices in Brazil, Mexico, the Netherlands and more. She has helped medical device clients register their products with regulators in Brazil, Mexico, Russia, Korea, and Japan since joining Emergo in 2006. 

Registration for this webinar is closed but a recording will be available. Please check back soon!