The vast majority of Medical Devices sold in Mexico are imported, mainly from the US and Canada due to the North American Free Trade Agreement (NAFTA), which allows easier movement of goods between the two countries. This can be a lucrative market for medical device manufacturers. Mexico has a robust private and public health sector. Private Institutions often request quotes from several suppliers while public institutions purchase through open invitations published in the DOF (Diario Oficial de la Federación).
Registration is not a simple process. Products can be grouped into the same product family depending on a variety of factors. Grouping products can be advantageous in terms of number of required registrations and timeline from submission to approval. There are a variety of registration routes available in Mexico and each has advantages and disadvantages to consider.
In this white paper we cover:
- 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:
Constanza de la Garza is a Senior Regulatory Affairs Specialist in Emergo's Mexico City office.