Article | July 3, 2025

Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials

Source: Med Device Online

By Julio G. Martinez-Clark, CEO, bioaccess

Brazil-GettyImages-157287554

Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape. After decades of operating under outdated frameworks, the country has emerged as Latin America’s most attractive destination for clinical research, thanks to groundbreaking legislative changes that have streamlined processes, enhanced predictability, and aligned with international best practices.1

This transformation represents more than just regulatory reform — it signals Brazil’s strategic positioning as a global clinical research powerhouse. With a diverse population exceeding 215 million people, world-class healthcare infrastructure, and now a modernized regulatory framework, Brazil offers medical device manufacturers unprecedented opportunities to conduct efficient, high-quality clinical trials that generate globally relevant data.2

The Legislative Breakthrough: Law 14.874/24 Reshapes Clinical Research

The cornerstone of Brazil’s regulatory revolution came with the enactment of Law 14.874/24 on May 28, 2024, taking effect on August 26, 2024.3 This landmark legislation represents the culmination of nearly a decade of negotiations, fundamentally transforming how clinical trials are conducted and approved in Brazil.

Streamlined Review Process Eliminates Double Approvals

Perhaps the most significant change introduced by Law 14.874/24 is the elimination of Brazil’s historically complex double-approval system. Previously, sponsors faced a bureaucratic maze, requiring approvals from both local ethics committees (ECs) and the federal National Research Ethics Commission (CONEP). This duplicative process often extended approval timelines to over 12 months, making Brazil less competitive compared to regional neighbors.

Under the new law, ethical analysis is now conducted solely by local ECs, dramatically simplifying the approval pathway. This single-instance review eliminates redundant assessments while maintaining rigorous ethical oversight, aligning Brazil with international best practices observed in Europe and the United States.3

Predictable Timelines Transform Startup Planning

The legislation establishes mandatory, predictable timelines that give medical device clinical trial sponsors unprecedented certainty in trial planning:3

  • Ethics committee reviews are capped at 30 business days from acceptance of complete documentation.3
  • ANVISA’s regulatory analysis cannot exceed 90 calendar days for trials intended for market clearance.
  • Additional information requests can extend EC review by a maximum of 20 business days.

These defined timelines represent a dramatic improvement from the previous unpredictable system, where approvals could languish for 12+ months without clear resolution dates. The new framework reduces overall approval time from 12 months to approximately 60 days for market clearance trials and 30 days for non-clearance studies.

Enhanced Participant Protection

Beyond efficiency gains, Law 14.874/24 strengthens participant protection through clearer informed consent processes and enhanced ethical oversight by accredited committees. The legislation mandates comprehensive post-trial access provisions and establishes clearer responsibilities for researchers and sponsors, ensuring that regulatory modernization doesn’t compromise patient safety.3

ANVISA’s RDC 837/2023: Modernizing Medical Device Regulations

Complementing the broader clinical research law, ANVISA’s Resolution RDC 837/2023, effective December 15, 2023, specifically addresses medical device clinical investigations.4 This regulation represents a complete overhaul of the previous framework, bringing Brazil into alignment with international standards while eliminating unnecessary bureaucratic barriers.

Consolidated Documentation Streamlines Submissions

RDC 837/2023 introduces the Clinical Investigation Dossier for Medical Devices (DICD), consolidating all required documentation into a single comprehensive submission. This unified approach eliminates the previous fragmented submission process, where sponsors navigated multiple separate requirements and forms.

The DICD includes standardized sections for comprehensive trial protocols, investigator qualifications and site information, risk-benefit analyses, informed consent documentation, and quality management systems.4

Risk-Based Approval Scope Reduces Regulatory Burden

A fundamental shift in RDC 837/2023 is the risk-based delimitation of ANVISA’s approval scope.4 The regulation establishes that only clinical investigations for Class III and IV medical devices intended for regulatory market clearance require ANVISA approval.4 This targeted approach offers several advantages: post-commercialization studies (Phase IV) proceed with ethics committee approval only, Class I and II device studies no longer require prior ANVISA consent, and academic research not intended for market clearance follows expedited pathways.

This risk-stratified approach mirrors international best practices, focusing regulatory resources on higher-risk devices while streamlining pathways for lower-risk investigations.

Automatic Approval Mechanism Prevents Delays

RDC 837/2023 includes a revolutionary automatic approval provision: if ANVISA fails to respond within 90 calendar days of receiving a complete DICD, the clinical trial may proceed based solely on ethics committee approval. This mechanism eliminates the historically problematic scenario where trials faced indefinite delays due to regulatory inaction.

ANVISA’s Business Intelligence Platform: Transparency Through Technology

In December 2024, ANVISA launched its business intelligence (BI) platform, built on Microsoft Power BI, representing a quantum leap in regulatory transparency and efficiency.2 This initiative positions Brazil among the most technologically advanced regulatory environments globally, rivaling systems deployed by the European Medicines Agency (EMA) and Health Canada.2

Real-Time Regulatory Intelligence

The BI platform provides unprecedented access to clinical trial data through interactive dashboards that enable study registration and traceability for all medical device investigations, real-time monitoring of approval timelines and regulatory decisions, advanced filtering capabilities by device category, risk class, and study phase, and public accessibility for researchers, manufacturers, and healthcare professionals.2

Competitive Advantages For Medtech Startups

Unlike static databases maintained by other regulatory agencies, ANVISA’s BI platform offers distinct advantages: enhanced usability through interactive visualizations rather than raw data dumps, real-time updates providing immediate insights into regulatory trends, localized market intelligence specific to Brazil’s medtech sector, and predictive analytics capabilities for strategic planning.2

This technological advancement enables medtech startups to make data-driven decisions about trial planning, site selection, and regulatory strategy, significantly reducing time-to-market risks.2

Revolutionary Approval Workflows: Two Distinct Pathways

Brazil’s new regulatory framework establishes two streamlined pathways, each optimized for different research objectives and market strategies.2

Pathway 1: Trials for Market Clearance

For clinical investigations intended to support Brazilian market clearance applications, the process features parallel review by ECs and ANVISA.2 The process includes simultaneous submission of DICD to both EC and ANVISA, a parallel review process that eliminates sequential bottlenecks, 30-day ethics review concurrent with 90-day regulatory assessment, automatic approval if ANVISA doesn’t respond within 90 days, and trial commencement once both approvals are secured.2

This parallel approach represents a fundamental shift from Brazil’s historically sequential review process, reducing overall timelines by 60 to 90 days compared to previous frameworks.2

Pathway 2: Non-Market Clearance Investigations

For trials not intended for Brazilian market clearance — including medical device early-stage feasibility studies, proof-of-concept research, and academic investigations — the process requires ethics committee approval only. The streamlined process involves a single submission to ethics committee, a 30-day review timeline with a possible 20-day extension, immediate trial commencement upon EC approval, and continuous monitoring and compliance oversight.2

This streamlined pathway positions Brazil as exceptionally attractive for early-phase research, enabling rapid validation of innovative technologies without regulatory delays.2

Comparative Analysis: Brazil’s Global Competitive Position

Brazil’s regulatory transformation places it among the world’s most competitive clinical trial environments.5,6 Recent comparative analysis reveals Brazil’s significant advantages in timeline comparisons with global leaders: Brazil’s new framework requires 30 to 90 days depending on pathway, while the United States FDA IDE process takes 180 to 270 days for high-risk devices, the European Union MDR requires 60 to 180 days with increasing complexity, Mexico takes 180 to 270 days and with limited infrastructure, Colombia takes 180 to 270 days with an unpredictable list of requirements, and Argentina requires 90 to 120 days with smaller patient populations.5,6,7

Brazil’s new framework demonstrates remarkable efficiency improvements: 90% reduction in approval timelines versus the previous system, 85% elimination of redundant documentation requirements, 75% decrease in regulatory query cycles, and 60% improvement in trial startup predictability.7 These metrics position Brazil competitively not just within Latin America but globally among leading clinical research destinations.7

Strategic Implications For Medical Device Manufacturers

Brazil’s regulatory revolution creates unprecedented opportunities for medical device manufacturers seeking efficient, cost-effective clinical development pathways.8 The combination of streamlined regulations, diverse patient populations, and advanced infrastructure positions Brazil as a strategic hub for global clinical research.8

The new framework particularly benefits early-stage companies seeking rapid proof-of-concept validation, established manufacturers requiring diverse patient populations, innovation-focused organizations needing flexible regulatory pathways, and cost-conscious sponsors seeking efficient resource allocation.2,8

Conclusion: A New Era For Brazilian Clinical Research

Brazil’s regulatory revolution represents more than administrative reform — it signals the country’s emergence as a global leader in clinical research innovation.1 Through Law 14.874/24, RDC 837/2023, and the new BI platform, Brazil has created a regulatory ecosystem that balances efficiency with safety, transparency with flexibility, and innovation with ethical oversight.9

These transformative changes position Brazil to capture an increasing share of global medical device clinical trials, particularly as the country leverages its unique demographic advantages and world-class healthcare infrastructure.2 For medical device manufacturers, Brazil now offers a compelling combination of regulatory efficiency, market access potential, and research quality that rivals any global destination.8

The regulatory revolution is already showing results, with industry reports indicating increased interest from international sponsors and growing confidence in Brazil’s clinical research capabilities. As these changes continue to mature, Brazil is poised to become not just Latin America’s clinical research leader, but a global benchmark for regulatory innovation and efficiency.1

References

  1. What to Know About Brazil’s New Clinical Research Law. PSI. [Online] 2025. https://psi-cro.com/brazil-new-clinical-research-law/.
  2. Trench Rossi Watanabe. [Online] April 12, 2024. [Cited: June 14, 2025.] https://www.trenchrossi.com/en/legal-alerts/brazilian-national-health-surveillance-agency-publishes-new-rules-on-clinical-trials-for-drug-marketing-authorization/.
  3. New Law Expected To Boost Clinical Research In Brazil. Clinical Leader. [Online] June 19, 2024. [Cited: June 14, 2025.] https://www.clinicalleader.com/doc/new-law-expected-to-boost-clinical-research-in-brazil-0001.
  4. Brisolla, Marcelo. LinkedIn. [Online] June 2024. [Cited: June 14, 2025.] https://www.linkedin.com/posts/marcelo-fran%C3%A7a-brisolla_rdc-8372023-english-version-activity-7142839924071854080-G48O/.
  5. Anvisa updates clinical trial regulations. Mattos Filho. [Online] December 6, 2024. [Cited: June 14, 2025.] https://www.mattosfilho.com.br/en/unico/updates-clinical-trial-regulations/.
  6. Licks Attorneys. [Online] July 31, 2024. [Cited: June 14, 2025.] https://www.lickslegal.com/post/new-regulatory-framework-for-clinical-research-in-brazil.
  7. Streamlining Clinical Investigations for Medical Devices. DDReg. [Online] January 23, 2024. [Cited: June 14, 2025.] https://resource.ddregpharma.com/blogs/streamlining-clinical-investigations-for-medical-devices/.
  8. Assessing the clinical trial ecosystem in Europe. European Federation of Pharmaceutical Industries and Associations. [Online] October 2024. [Cited: June 14, 2025.] https://www.efpia.eu/media/0ipkatpg/efpia-ct-report-embargoed-221024-final.pdf.
  9. New Oncologic Drugs from 2008 to 2023—Differences in Approval and Access between the United States, Europe and Brazil. Barreto RB, Izidoro AM, Miranda MHF. 31, Toronto, Ont. : s.n., 2024, Curr Oncol., Vol. 2.

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).