Anvisa Modernization Plan 2025 – Medical Device Regulatory Progress

Brazil’s Anvisa Modernization Plan 2025 reports significant progress in medical device regulation, with a 40% reduction in the post-registration backlog. Anvisa has also improved review timelines for biological products, clinical research, and radiopharmaceuticals. Investments in artificial intelligence and recruitment of over 100 new specialists signal a major step toward faster, more efficient regulatory operations in Brazil.

Key Achievements in Medical Device Regulation

Anvisa highlights several milestones from its focused modernization efforts:

• Backlog reduction: Post-registration processes for medical devices reduced by approximately 40%, one of the biggest achievements to date.

• Clinical research review: Review times cut by 44%, clearing roughly a quarter of the existing queue.

• Radiopharmaceuticals: Entire pipeline cleared, with normal operations expected early 2026.

• Biological products: Review time decreased from 22 months to 9 months, speeding patient access to critical therapies.

Strategic Investments and Team Expansion

To support these gains, Anvisa is taking proactive steps:

• Artificial intelligence: 25 million reais invested in AI to streamline evaluation and monitoring processes.

• New specialists: 102 new team members hired — the largest workforce expansion since 2014.

• Projected queue reduction: Expected 50% reduction in queues over six months, with full normalization within one year.

These measures are intended to create a more agile, transparent, and reliable regulatory environment for medical devices and other health products in Brazil.

Implications for Medical Device Manufacturers

For companies operating in Brazil, the modernization plan offers several benefits:

• Faster approvals: Shorter post-registration and review times accelerate market entry.

• Predictable timelines: Reduced backlog allows for more accurate planning of product launches and clinical studies.

• Improved regulatory guidance: Increased staffing and AI adoption support quicker interactions with Anvisa and more consistent decisions.

• Enhanced capacity: Clearance of radiopharmaceutical and biological product pipelines frees resources for new submissions.

Internal links

• Learn more about Anvisa Medical Device Registration

• Learn about our newly launched AI builder currently operational for Brazil ANVISA notifications and registrations

External links

• Anvisa Modernization Plan announcement (Portuguese)

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