Adapting to Change: How New Regulatory Frameworks Are Shaping the Brazilian Medical Device Market
Regulatory evolution is constant in healthcare, and in Brazil, recent updates from Anvisa have significantly reshaped how manufacturers, distributors, and importers operate.
From product registration to post-market monitoring, these changes are driving greater transparency, predictability, and alignment with global best practices.
For companies in the medical device sector, staying ahead of regulatory change is no longer optional: it’s a strategic necessity.
A Move Toward International Harmonization
In the past few years, Anvisa has intensified efforts to harmonize its regulations with international frameworks such as the IMDRF (International Medical Device Regulators Forum), the WHO, and the Pan American Health Organization (PAHO).
This alignment facilitates international cooperation, simplifies documentation for multinational manufacturers, and strengthens Brazil’s credibility as a regulatory reference in Latin America.
One major milestone was the publication of RDC 751/2022, which restructured the classification, registration, and labeling requirements for medical devices, replacing the former RDC 185/2001.
The new resolution clarifies risk criteria, updates terminology, and introduces more efficient mechanisms for digital submission.
Key Areas of Regulatory Modernization
Recent updates reflect Anvisa’s focus on modernization, transparency, and digital efficiency. Among the highlights are:
Digital transformation of submissions: The move toward electronic petitions and online systems has reduced bureaucracy and improved traceability of processes.
Risk-based regulatory approach: By calibrating requirements according to product risk, Anvisa allows faster approval for low-risk devices while maintaining rigorous evaluation for high-risk technologies.
Good Manufacturing Practice (GMP/CBPF) improvements: Updated inspection and certification procedures now prioritize companies with consistent quality systems, improving oversight while reducing bottlenecks.
Post-market surveillance reinforcement: The agency has expanded obligations for adverse event reporting and implemented new channels for transparency, improving patient safety and data integrity.
Together, these updates reflect a broader shift: from procedural control to outcome-based regulation, focused on product quality, reliability, and real-world performance.
How These Changes Affect Market Access
For manufacturers, the new regulatory environment brings both challenges and opportunities.
Companies that adapt quickly to Anvisa’s updated frameworks gain a competitive advantage: faster approvals, greater operational predictability, and stronger market trust.
Those that delay adaptation, however, risk compliance gaps and longer approval timelines.
In a market as dynamic as Brazil, regulatory readiness has become a decisive factor in business success.
Brisa’s Role: Turning Regulation into Strategy
At Brisa, we continuously monitor regulatory changes, analyze their implications, and translate them into actionable strategies for our clients.
Our team supports manufacturers and distributors in updating documentation, redefining internal procedures, and aligning global compliance standards with Brazilian requirements.
By combining regulatory intelligence, technical expertise, and local insight, we ensure that adaptation becomes an opportunity, not a challenge.
Conclusion: Evolving with the Market
The modernization of Brazil’s regulatory landscape reflects a commitment to safety, innovation, and global alignment.
For the medical device industry, it signals a new era of efficiency, transparency, and strategic partnership with regulators.
At Brisa, we help our clients evolve with this transformation, ensuring that each update becomes a step toward greater competitiveness and sustainable growth.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
