The regulatory landscape in Europe and Brazil is changing. The Medical Devices Regulation brings with it many innovations and challenges manufacturers. Brazil is on the way to becoming more efficient and accelerating the approval processes. But where are the similarities or differences?
In this seminar, you will first learn about the similarities between the two regulatory markets. You will then systematically learn about the differences. Step by step, you will first be guided through the various steps of product development, discussing the main differences in requirements and highlighting special features. You will then get to know the approval process and how it interacts with the authorities. At the end, the post-market phase will be highlighted and how you can usefully supplement existing systems in order to meet the additional requirements.
- Overview of the main regulatory requirements in Brazil & the EU
- Introduction of the essential elements required for product development
- Presentation of the similarities and essential differences to be taken into account in the context of product development
- Comparison of approval processes in Brazil and the EU
- Presentation of the different approval requirements and practical information on the standardisation of the approval documentation
- Presentation of the Post-Market Surveillance (PMS) requirements with practical hints to complement existing PMS systems in a meaningful way