Thinking of selling your medical device in Mexico? Mexico can be a lucrative market, and it imports the majority of its medical devices from the US and Europe. However, registration is not a simple process, and products can be grouped into the same product family depending on a variety of factors. There are a variety of registration routes available in Mexico and each has advantages and disadvantages to consider.
In this white paper we cover, we'll answer your biggest questions about how to register your medical device in Mexico. You will learn:
- Classification and grouping criteria
- Various COFEPRIS registration routes
- Examples of different registration routes and expected timelines
- Examples of when a manufacturer may find it advantageous to leverage approval in another market or proceed with the standard process
- Phases of the registration process
- Technovigilance after market approval
About the Author:
Katie Senechal is Global Operations Manager – Latin America at Emergo, overseeing Emergo's consulting service and operations in Mexico and Brazil. In this role, Katie helps clients access device markets in Latin America.