Emergo Podcast: Mexico’s medical device registration process

By Stewart Eisenhart, Emergo Group

Emergo’s latest podcast covers medical device registration requirements for Mexico, Latin America’s second-largest device market behind Brazil.

In this podcast, Emergo International Operations Manager Katie Senechal, Business Development Manager Miguel Torres Tello and Senior Regulatory Affairs Specialist Constanza de la Garza—all based in our Mexico City office—explain several pertinent issues to consider when applying to COFEPRIS for market authorization in Mexico.

• Device classification rules
• Mexico Registration Holder (MRH) in-country representation
• Certified quality system requirements
• COFEPRIS registration and review timeframes
• Mexico registration modification processes

Additional information on device registration in Mexico is available via our Mexico whitepaper, registration overview video and regulatory process chart.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post Emergo Podcast: Mexico’s medical device registration process appeared first on MassDevice.

from MassDevice http://ift.tt/1QJumzj