Expected regulatory changes in South America

In the last years South American countries have been shaken by constant revisions of regulations about medical devices both in the registration and clinical trials arena. The goal of this session is to understand the changes which are effective, the others which are expected to come, how they impact in the planning and in the activities of your product for a fast market access, including the dossier preparation, the traditional grey areas of each country regulatory agency and contingency plans to prevent delays in the review and approval process.