This is a compilation of the recent regulatory updates for Brazil. Every week, we post an update of what's new, which you can view here.
- February 24: ANVISA's extended pilot is planned to run in parallel with the eight month review and final regulation period. This timing means the 36 month implementation timeline would begin in April 2019 and end in April 2022 for all companies that have a requirement under the law and the products that are covered by the law.
- June 3: ANVISA reviewed timelines and the pilot will be extended until April 2019. Communication standards are being considered for both vertical government reporting and a potential use for horizontal peer to peer communications. A new version of communications guidelines has been published.
- April 8: Updated SNCM technical guidelines were circulated for law, which is currently in a pilot testing stage.
- March 11: ANVISA published the list of the pilot participants for the May through September pilot.
- January 14: Pilot execution and testing is now going to get underway in April/May when the central system is ready for integration and data management.