Medical Device Registration Costs and Timelines for Brazil, Mexico, and Colombia

Entering new international markets comes with layers of regulatory, financial, and operational complexity. Before you commit resources, you need a clear understanding of how much registrations will cost and how long approvals will take in the countries you’re targeting.

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This video explores medical device and IVD registration in Latin America’s three largest markets: Brazil, Mexico, and Colombia. Instead of looking only at government fees, it highlights the range of expenses companies must plan for, including translation costs, consulting, in-country representation, and ongoing post-market obligations. You’ll also learn why timelines vary by device class and submission pathway, and how smart planning can keep your market entry strategy on track.

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For companies eyeing Brazil, the largest economy in the region, the video outlines the pivotal role of ANVISA and why choosing the right registration holder can make or break your project. For Mexico, it examines how COFEPRIS approvals are evolving, including new accelerated pathways that can reduce evaluation times. And in Colombia, it touches on INVIMA’s unique requirements, including recent changes that affect how companies must report device information.

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The takeaway: medical device registration in Latin America is not one-size-fits-all. Costs and timelines are influenced by device classification, certification needs, and post-approval responsibilities. The more accurately you estimate these factors, the better you can align your regulatory strategy with your business objectives.

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For a deeper dive, read our article on costs and timelines for device registration in major Latin American markets.