Initiative seeks to strengthen the regulatory basis for the reprocessing and regularization of health products
The National Health Surveillance Agency (Anvisa) has announced the opening of a targeted consultation on the new proposal for a federal regulatory framework for medical devices. The initiative will be launched at a virtual event on May 13, at 9am (Brasília time), via the Microsoft Teams platform.
Focus on reusable and single-use medical devices
The targeted consultation aims to discuss and collect contributions on the framework and regularization of reusable and single-use medical devices. In addition, good practices for processing these products will be addressed, with a view to improving health safety and regulatory efficiency in the sector.
Participation restricted to SNVS
The event and consultation are exclusive to the entities that make up the National Health Surveillance System (SNVS). The active participation of representatives of this system is considered essential for the construction of more robust regulations in line with the local and regional realities of health surveillance.
Submission of contributions: from May 13 to June 13
The period for submitting contributions will run from May 13 to June 13, 2025. The suggestions gathered during this process will support the drafting of four new regulations.
Dissemination of forms and next steps
The links to the contribution forms will be made available during the launch event and will also be accessible on Anvisa’s portal. The collaborative process is expected to strengthen regulation and increase transparency in the Agency’s technical decisions.
Consolidating regulations and strengthening the regulatory system
With this initiative, Anvisa is seeking to consolidate a more robust, evidence-based regulatory framework that reflects the practical needs of the SNVS. The aim is to increase the effectiveness of health surveillance on medical devices, promoting greater patient safety and rationality in the adoption of health technologies.
