Overview
Brazil’s national health surveillance agency, ANVISA, has launched a targeted public consultation as part of its effort to revise and modernize the regulatory framework for medical devices. This initiative aims to align Brazilian regulations with international best practices, enhance patient safety, and foster innovation. Stakeholders across the health and regulatory sectors are invited to submit their contributions and insights.
Introduction
Medical devices play a critical role in healthcare systems worldwide—supporting prevention, diagnosis, treatment, and rehabilitation. As technology evolves rapidly, regulatory systems must adapt to ensure both efficiency and safety.In response to these global shifts, ANVISA has initiated a public consultation on a new regulatory framework for medical devices in Brazil, reflecting a significant step toward modernization and regulatory convergence.
Important Developments
The proposed update demonstrates ANVISA’s commitment to international harmonization, particularly through alignment with frameworks like the International Medical Device Regulators Forum (IMDRF).
Key highlights of the draft regulation include:
- Updated risk classification criteria for medical devices;
- Streamlined procedures for device registration and notification;
- Clearer rules for technical documentation updates;
- Post-market surveillance and traceability enhancements
- Greater transparency and engagement with regulated sectors.
These changes are designed to improve regulatory efficiency, reduce unnecessary barriers, and facilitate the introduction of cutting-edge technologies in Brazil’s healthcare system—while maintaining a strong focus on patient safety.
Importantly, the public consultation phase allows stakeholders—such as manufacturers, importers, health professionals, industry associations, and consumers—to provide feedback and influence the final version of the regulation. The draft will remain open for comments for a set period (typically 45 to 60 days), during which ANVISA will collect and analyze all contributions.
Conclusion
ANVISA’s new public consultation signals a pivotal moment for the medical device sector in Brazil. By revising and aligning its regulatory framework with international standards, the agency reinforces its commitment to patient safety, innovation, and global competitiveness.
Now is the time for international stakeholders to get involved. If your company or organization works with the Brazilian market—or plans to—it’s essential to review the proposed changes and submit your input.
Your voice can help shape a more efficient, modern, and harmonized regulatory environment in Brazil.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
 Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.Â