The Brazilian Health Regulatory Agency, Anvisa, has taken a significant step toward streamlining the medical device registration process. In a recent move, Anvisa announced that it will now consider analyses conducted by equivalent foreign regulatory authorities when evaluating petitions for device registration.
The New Procedure
On April 8, 2024, Anvisa published Normative Instruction (IN) 290/2024, which outlines an optimized procedure for analyzing and deciding on petitions related to medical device registration. This new approach aims to enhance efficiency while maintaining rigorous safety standards.
Trust in Regulatory Equivalents
The adoption of this streamlined process aligns with recommendations from the World Health Organization (WHO). By recognizing approvals from foreign regulatory bodies, Anvisa can expedite the evaluation of products that have already been deemed safe and effective elsewhere. Specifically, medical devices authorized by regulatory authorities in Australia, Canada, the United States, and Japan will benefit from this accelerated review process.
Key Points of IN 290/2024
Here are the essential details of the new instruction:
- Effective Date: Starting from June 3, 2024, medical devices approved by the four specified foreign regulatory authorities can undergo an abbreviated analysis process. Companies seeking registration must demonstrate that their products intended for the Brazilian market align with the same production characteristics, indications, and intended use approved by the recognized regulatory authority.
- Industry Consultation: The publication of IN 290/2024 followed extensive discussions with stakeholders in the regulated sector. Feedback provided during the public consultation process (CP 1.200/2023) informed the final regulation.
Benefits and Next Steps
The implementation of this procedure is expected to bring several benefits:
- Faster Access: Companies can now navigate the registration process more swiftly, reducing time-to-market for medical devices.
- Global Alignment: By recognizing approvals from reputable foreign authorities, Brazil aligns itself with international best practices.
- Virtual Seminar: Anvisa plans to organize a virtual seminar soon to disseminate information about the new norm and address any questions from interested companies.
Anvisa’s decision to leverage foreign regulatory analyses demonstrates its commitment to efficiency, safety, and global harmonization in the medical device sector. As Brazil continues to advance its healthcare infrastructure, this regulatory update will play a pivotal role in ensuring timely access to innovative technologies for its population.