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    Market approval of medical devices in LATAM

    The market for medical devices in Latin America (LATAM) is one of the largest in the world and healthcare in this region heavily relies on technologies developed abroad. These two characteristics make the LATAM market very attractive to manufacturers from the US and European Union. However, entering the market and navigating the constantly evolving regulatory landscape poses a challenge to many businesses. As a prelude to our upcoming in-depth seminar, this keynote gives you a first overview on recent regulatory changes and explores basic requirements for product registration in Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA) and Argentina (ANMAT). Apart from learning about the pros and cons of working with local subsidiaries, distributors or consultants, you will also understand the advantages of performing clinical investigations in these countries. In the corresponding seminar, you will then deep dive into these and many more regulatory topics which will enable you to build a successful market access strategy for LATAM.

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