Emergo Group Inc. Opens Office in Mexico to Help Medical Device Companies Access Market

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Medical device consulting firm Emergo Group Inc. recently opened an office in Mexico to meet increasing demand from clients to offer regulatory approval and in-country representation services for this growing market. Mexico is the second largest medical device market in Latin America, second only to Brazil.

Emergo Group CEO Rene van de Zande notes, “Last fall we surveyed our 1,000 medical device clients and asked them which markets they wanted to enter in 2009. About 40% said they were interested in expanding into Mexico but needed our help to make that happen because the regulatory process can be challenging. We’re responding to that need.”

Emergo helps companies coordinate, submit and maintain Mexico medical device registrations with COFEPRIS, the agency within the Secretaria de Salud (Mexican Ministry of Health) that oversees medical devices in Mexico.

In-country Registration Holder service offers additional flexibility to medical device companies

The firm also provides Mexican Registration Holder representation which allows the manufacturer to maintain control over their medical device registration(s) with COFEPRIS instead of having a local distributor fulfill this role. As a result, the manufacturer can add or change distributors in Mexico at any time.

In addition to registration consulting, Emergo Mexico helps medical device companies find, evaluate, select and manage distributors in Mexico.