Brazil Emerges as Latin America's Clinical Research Powerhouse: What Medtech Companies Need to Know
Brazil has entered a transformative era for medical device clinical trials, driven by groundbreaking regulatory reforms and strategic investments in healthcare infrastructure. With the implementation of Law 14.874/24 and RDC 837/2023, the country is positioning itself as the most efficient clinical research hub in Latin America. For Medtech companies eyeing global expansion, here’s why Brazil deserves your attention.
1. Regulatory Revolution: Faster Approvals, Stronger Protections
Brazil’s new clinical trial framework slashes approval timelines while enhancing patient safety:
Parallel reviews: Ethical committees (ECs) and ANVISA now conduct concurrent evaluations, reducing approval times from 12 months to 60 days for trials intended for regulatory submissions.
Automatic greenlight: If ANVISA doesn’t respond within 90 calendar days, trials can proceed with EC approval alone.
Exemptions for low-risk devices: Class I/II devices and post-market studies no longer require ANVISA pre-approval, accelerating feasibility studies.
These changes align Brazil with international standards while addressing historical bottlenecks. As of February 2025, ANVISA’s new Business Intelligence platform provides real-time trial tracking—a first in Latin America.
2. Demographic Goldmine: 215 Million Reasons to Choose Brazil
Brazil’s population offers unmatched diversity for robust clinical data:
Genetic variability: A mix of Indigenous, European, African, and Asian ancestries enables trials targeting diverse metabolic responses.
Disease prevalence: High rates of cardiovascular conditions (28% of deaths), diabetes (8.1% prevalence), and cancer support rapid patient recruitment.
Public healthcare integration: The SUS system provides access to 75% of the population, enabling cost-effective recruitment through 3,000+ research centers.
A 2024 study showed 15% higher patient retention rates in Brazilian trials compared to global averages, attributed to strong physician-patient relationships.
3. Cost Efficiency Without Compromise
Brazil delivers First World research quality at emerging market costs:
40% lower operational costs vs. U.S./EU trials.
20% faster recruitment timelines for cardiovascular device studies.
34% tax incentives for R&D investments in São Paulo and Rio de Janeiro.
While slightly pricier than India/China, Brazil’s ISO 14155 compliance and FDA-aligned regulations reduce regulatory risks for global submissions.
4. ANVISA’s Evolving Role: Opportunities & Challenges
Despite progress, staffing shortages at ANVISA require strategic navigation:
25% workforce reduction in 2024 due to retirements.
90-day review delays for high-risk device submissions.
Pro tip: Partner with Brazilian CROs to leverage new regulatory reliance pathways (IN 290/2024), accepting approvals from 12 recognized foreign agencies including FDA and EMA.
5. How Brazil Stacks Up Against Regional Competitors
Brazil dominates in complex device trials, while Argentina excels in oncology and Colombia in rare diseases. For multi-center studies, 62% of sponsors now include Brazil as their Latin American anchor.
Success Stories: Brazilian Innovation in Action
BrainGate-Brazil: A UNIFESP-led trial achieved 92% accuracy in neural signal decoding for motor-impaired patients using BCIs.
Spinal Cord Stimulation Breakthrough: Hospital Sírio-Libanês reduced chronic pain by 67% in a 300-patient neurostimulation study.
Portable Retinal Diagnostics: SENAI’s $150 handheld device detects diabetic retinopathy with 98% sensitivity, now deployed in 200 SUS clinics.
The Road Ahead: 2025–2030 Outlook
With Medtech CRO revenues projected to hit $950M by 2030, Brazil is investing heavily in:
AI integration: A new $3.6B initiative for AI-powered diagnostics and wearables.
UDI compliance: Full implementation for Class IV devices by July 2025.
Rare disease networks: 12 new centers targeting sickle cell anemia and ALS.
Why Partner with bioaccess® in Brazil?
As Latin America’s leading Medtech CRO, we help clients:
Navigate ANVISA’s updated clinical investigation requirements (RDC 837/2023)
Leverage SUS partnerships for cost-effective patient recruitment
Implement ANVISA’s new BI platform for real-time trial analytics
“Brazil isn’t just a trial location—it’s where global Medtech standards get redefined.” – Julio G. Martinez-Clark
Julio G. Martinez-Clark is a recognized expert in Latin American clinical research, with 18 years of experience guiding Medtech companies through Brazil’s regulatory landscape. Connect with him on LinkedIn or tune into the LATAM Medtech Leaders podcast for more in-depth insights.
Ready to accelerate your Medtech trial timelines?
Contact bioaccess® to explore Brazil’s clinical research opportunities.
