ANVISA presented the latest results of its Strengthening and Modernization Plan during a meeting of the Executive Group of the Health Economic-Industrial Complex (GECEIS), held in São Paulo on November 24, 2025.
The initiative aims to reduce regulatory backlogs and improve review timelines across several product categories.
Key progress highlights include
- Medical Devices : A dedicated task force has reduced the post-registration backlog by 40% and launched optimized, category-based review processes.
Synthetic Medicines : Measures such as category grouping, regulatory reliance, and withdrawal notices are expected to result in the highest number of approvals since 2019 during 2025.
Focus on medical devices backlog reduction
On the same day, ANVISA also presented the webinar “Plan for Reducing Backlogs in Medical Devices”, outlining:
- Operational proposals to accelerate reviews
- Practical guidance for petition submissions
- Actions aimed at improving efficiency in medical device regularization processes
These initiatives are designed to make regulatory procedures more agile and predictable, contributing to a gradual reduction of pending reviews.