Latest / Medical Device Global Market Access
From Europe to Brazil: Bridging the CE Mark and ANVISA Gap
This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between European requirements and Brazil's ANVISA regulations, focusing on the essential documentation, testing, and certification gaps that manufacturers must address for successful registration. • Is a CE mark enough to sell your medical device in Brazil? • What is a Brazil Registration Holder (BRH) and why is it mandatory? • How does ANVISA's technical dossier differ from a European Technical File? • Can an MDSAP certificate replace the need for an…
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