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Latin America market access consulting for medical device and IVD companies

The nations of Latin America can be profitable targets for medical device and IVD manufacturers hoping to expand their commercial reach. The region is home to two major medical device markets—Brazil and Mexico—with opportunities for growth in smaller markets such as Peru, Colombia, and Costa Rica. Each country has its own regulatory authority, as well as unique registration, quality, and clinical requirements. Success in Latin America often requires deep familiarity with each market’s regulatory scheme.

Local expertise to help you navigate medical device and IVD regulatory requirements in Latin America

With teams of bilingual medical device regulatory experts in Mexico, Brazil, and throughout Latin America, Emergo by UL Solutions has the expertise and the presence to act as your regulatory partner. We can:

  • Help you to strategize which markets may be appropriate for your healthcare product
  • Liaise with local regulators and health authorities to identify the best regulatory pathway for your product, as well as clinical and testing requirements
  • Provide authoritative guidance on product classification and submissions to government agencies
  • Act as your in-country representative in Brazil, Mexico, Peru, Colombia, and Costa Rica
  • Streamline regulatory processes and provide intelligence via the RAMS digital RA/QA platform