Brazil is one of the world’s top markets for medical devices. Until 2010, only a few devices were specified by ANVISA as needing INMETRO certification. Now, most electromedical devices and some other specific dental devices and even others require INMETRO certification before submitting to ANVISA for market approval. If your company is exporting to Brazil, you need to know whether the changes affect your products and understand what is required.
This one-hour recorded webinar reviews the requirements for market approval of medical products in Brazil. The instructor discussed the INMETRO certification process for medical devices, ANVISA registration (including 2010 new requirements by ANVISA for all medical devices) and how to integrate your INMETRO certification into your global launch plan.
- Overview of INMETRO certification for medical products in Brazil
- INMETRO process for medical devices
- Testing requirements
- Post-certification and duration of certification
- Requirements for ANVISA registration
- 2010 – new requirements by ANVISA for all medical devices
- How to integrate your INMETRO certification
- Case studies / examples