Brazil's Clinical Trial Revolution: How New Laws Are Reshaping Latin America's Medical Device Research Landscape
Brazil is on the cusp of a clinical research revolution, poised to reshape the landscape of medical device trials in Latin America and beyond. With the recent enactment of Law 14.874/24, this South American powerhouse is setting new standards for efficiency, innovation, and patient protection in clinical research.
Imagine a country where groundbreaking medical devices can be tested with unprecedented speed and precision, a diverse population of over 215 million people offers unparalleled opportunities for inclusive research, and cutting-edge facilities rival those of the world's most advanced nations. This is the new reality of clinical trials in Brazil.
From brain-computer interfaces that give hope to those with severe motor disabilities to innovative neurostimulation devices tackling chronic pain, Brazil is rapidly becoming a hotbed of medical innovation. But what's driving this transformation? How does Brazil's approach compare to its Latin American neighbors and global competitors?
This article will delve into the factors propelling Brazil to the forefront of medical device research. We'll explore:
The game-changing impact of Law 14.874/24 on approval timelines and patient protection
Brazil's unique demographic advantages and efficient patient recruitment strategies
The cost-effectiveness of conducting medical device trials in Brazil compared to other global destinations
Real-world success stories that showcase Brazil's research capabilities
Whether you're a medical device manufacturer, a clinical researcher, or simply curious about the future of healthcare innovation, this exploration of Brazil's ascent in the clinical trial world promises insights that will reshape your understanding of global medical research. In this article, we will uncover how Brazil is not just participating in the future of medical device development – it's helping to create it.
Brazil is a Clinical Research Powerhouse
Brazil has established itself as a leader in clinical research within Latin America thanks to a confluence of factors that make it an attractive destination for clinical trials. With a population exceeding 215 million, Brazil offers researchers access to a sizeable and diverse pool of potential trial participants. (1) This diversity—encompassing ethnicity, genetics, and socioeconomic background—aligns perfectly with the growing emphasis on inclusive clinical trials, as highlighted by regulatory bodies such as the U.S. Food and Drug Administration (FDA). (2)
In addition to its diverse population, Brazil is positioned within a rapidly growing Latin American medical device contract research organization (CRO) market. It is projected to reach a revenue of USD 950 million by 2030, with a compound annual growth rate of 9% from 2024 to 2030. (3) Beyond this regional growth potential, Brazil boasts a robust infrastructure for clinical research. The country has over 3,000 research centers, including public universities, private hospitals, and specialized clinics. (4) These centers are staffed by qualified professionals with extensive experience conducting clinical trials according to international standards.
Brazil’s CRO ecosystem boasts a dynamic blend of well-established global leaders and nimble small to medium-sized enterprises (SMEs), providing sponsors with various options to meet diverse project requirements. Renowned international CROs like IQVIA and PAREXEL bring a wealth of global expertise and comprehensive service portfolios, ensuring robust operational frameworks and adherence to international standards. Meanwhile, local SMEs distinguish themselves with their deep understanding of Brazil’s regulatory and cultural landscape, offering tailored, region-specific insights, greater flexibility, and personalized client engagement. This synergy between global and local players positions Brazil as a strategic hub for clinical research.
Brazil's advanced healthcare system, including the Sistema Único de Saúde (SUS), which provides access to healthcare for over 75% of the population, further enhances its appeal as a clinical research destination. (5)
Overview of Brazil’s Healthcare System
Brazil’s healthcare system is a complex network of public and private institutions providing comprehensive medical services to its population. The backbone of this system is the Unified Health System (Sistema Único de Saúde, SUS), established in 1988 to provide universal healthcare access to all Brazilian citizens. (4) This system has played a crucial role in supporting clinical research by providing a vast patient base and an extensive network of healthcare facilities.
The Brazilian healthcare infrastructure is characterized by its state-of-the-art medical facilities, particularly in major urban centers. Hospitals like the Albert Einstein Hospital in São Paulo and the Sírio-Libanês Hospital are renowned for their advanced medical technology and research capabilities. (6) These institutions often collaborate with top universities and research centers, creating a fertile ground for clinical trials and medical innovations.
The Oswaldo Cruz Foundation (FIOCRUZ), one of Latin America's most prominent science and technology health institutions, exemplifies Brazil’s commitment to medical research. FIOCRUZ conducts biological and biomedical research, develops vaccines, and provides high-quality public health services. (7) Its extensive network and partnerships with international organizations have positioned Brazil as a key player in global health research.
Brazil’s medical education system also contributes significantly to its research capabilities. The country boasts over 300 medical schools, producing many healthcare professionals and researchers annually. (8) This constant influx of skilled professionals ensures a steady supply of qualified personnel for clinical trials.
Integrating research activities within the public healthcare system has been crucial for Brazil’s success in clinical trials. Many SUS hospitals are research sites for efficient patient recruitment and data collection. This integration ensures that research outcomes can quickly translate into public health policies and practices. (9)
Despite these strengths, it is essential to note that Brazil’s healthcare system faces challenges, including regional disparities in access to advanced medical facilities. However, these challenges have also spurred innovations in telemedicine and mobile health solutions, opening new avenues for clinical research in remote areas. (10)
The New Brazilian Clinical Research Law 14.874/24 and Its Effects
In May 2024, Brazilian President Luiz Inácio Lula da Silva approved Law 14.874/24, which took effect in August 2024. This landmark legislation marks a significant step forward for clinical research in Brazil, fundamentally transforming the regulatory landscape and approval processes. (11) Key changes introduced by the law include:
Streamlined Review Process:
Ethical analysis is now conducted solely by local ethics committees (ECs)
Elimination of duplicate approvals between local ECs and the National Research Ethics Committee (CONEP)
Simplified submission requirements for sponsors
Predictable Timelines:
EC reviews are capped at 30 business days
National Health Surveillance Agency (ANVISA)'s review is limited to 90 business days
Overall approval time reduced from 12 months to approximately 60 days
Additional information requests can extend EC review by up to 20 business days
Protection for Participants: The legislation offers greater protection, including clearer informed consent processes and ethical oversight by accredited committees.
Incentives for Rare Diseases and Pediatric Research: The law encourages research in rare diseases and pediatric populations—areas where Brazil has the potential to lead globally due to its genetic diversity.
These changes are expected to attract more investment, encourage pharmaceutical and medical device innovation, and solidify Brazil’s position as a top destination for clinical trials. (12)
Another significant regulatory update occurred in December 2023 with the publication of RDC 837/2023 by ANVISA. (13) This resolution brings several changes that could potentially impact medical device clinical trials:
It consolidates the submission process, allowing all documentation to be submitted under a single dossier called the Clinical Investigation Dossier for Medical Devices (DICD).
The scope of ANVISA's approval now focuses on clinical investigations for risk class III and IV medical devices.
Post-commercialization studies and those related to risk class I and II medical devices no longer require ANVISA's prior approval.
You do not need to obtain ANVISA approval to start recruiting patients for your first-in-human clinical trial with investigational high-risk devices in Brazil, given that the results of this study will not support the registration of Risk Class III and IV medical devices in Brazil.
These changes aim to streamline the process and align Brazilian practices with international standards, potentially increasing the number of clinical trials of medical devices.
The Clinical Trial Approval Workflow: Key Phases and Steps
The approval process for clinical trials in Brazil follows a structured approach that enhances efficiency and clarity. Initially, sponsors submit the necessary documentation to the EC and ANVISA. This submission marks the beginning of parallel review processes. The required documents typically include the trial protocol, the investigator’s brochure, and informed consent forms.
During the review and assessment phase, the EC conducts its ethical review, which is expected to be completed within 30 business days. Meanwhile, ANVISA carries out its regulatory review, which must be finalized within 90 business days. If either entity requires additional information, these requests will be handled within specified timeframes to ensure a timely review.
Final approvals from both the EC and ANVISA are necessary before a trial can commence. Once dual authorization is granted, the clinical trial can officially begin. However, continuous monitoring and reporting are mandated throughout the trial period to ensure compliance with ethical and regulatory standards.
Based on the recent regulatory updates in Brazil, you do not need to obtain ANVISA approval to start recruiting patients for your first-in-human clinical trial with an investigational high-risk device in Brazil, given that the results of this study will not support the registration of Risk Class III and IV medical devices in Brazil.
Navigating the Complexities of Importing Clinical Trial Materials into Brazil: Challenges and Opportunities
The rewards of conducting clinical trials in Brazil, one of the world’s largest healthcare markets, can be significant. However, success often involves navigating a complex web of import regulations and logistical challenges. For sponsors looking to bring clinical trial materials into the country, understanding the nuances of the process is crucial to avoid delays, manage costs, and ensure trial success.
Brazil’s regulatory framework, logistical infrastructure, and geographical expanse can pose challenges, but these obstacles can be turned into opportunities with the right approach. Here’s what sponsors need to know to streamline the process and capitalize on Brazil’s growing potential for clinical research.
Understanding the Import Process: Structured Yet Complex
Importing clinical trial materials into Brazil is not a straightforward task, even for non-commercial samples. The process involves several key steps:
Registration with SISCOMEX: The Integrated Foreign Trade System (SISCOMEX) requires importers to complete a registration process that can take a few days to a few weeks, depending on the accuracy of documentation and the workload of authorities. (14)
Obtaining a RADAR License: Importers must secure the Registro e Rastreamento da Atuação dos Intervenientes Aduaneiros (RADAR) license, which can sometimes take weeks for approval. Without a RADAR license, companies must rely on third parties to import materials on their behalf. (15) (16)
Securing an Import License: An import license issued by the Ministry of Health is mandatory for bringing clinical trial materials into Brazil. Depending on the Ministry’s workload, obtaining this license can take 7 to 45 days. Sponsors should account for this timeline during the planning phase to avoid delays. (17)
Regulatory Approvals: Approval from Brazil’s National Health Surveillance Agency (ANVISA) is mandatory for clinical trial materials. The agency ensures that imported goods meet stringent health and safety standards, but this step can add weeks to the timeline. (18)
Customs Clearance: Brazil’s customs process involves document verification, inspections, and valuation analyses. Depending on the complexity, clearance can take a few days to several months. (19) (20)
Key Challenges to Consider
Documentation Requirements: Brazil’s import process demands detailed documentation, including import licenses, certificates of analysis, and technical files. Missing or incomplete paperwork can result in significant delays. (21)
Regulatory Complexity: Navigating ANVISA’s regulations can be time-consuming, particularly for companies unfamiliar with Brazilian requirements. Understanding these regulations upfront is essential to avoid bottlenecks.
Logistics and Infrastructure: Brazil’s vast geography and reliance on road transport (60% of goods move by road) can pose logistical challenges. Seasonal weather conditions, such as heavy rains or droughts, further complicate transportation routes, potentially delaying the delivery of clinical trial materials. (22) (23)
Customs Delays: The customs process in Brazil assigns shipments to one of four clearance channels—green, yellow, red, or grey—each with varying levels of scrutiny. Shipments flagged for physical inspection or valuation analysis can face delays of up to 120 days. (19)
Turning Challenges into Opportunities
While the import process may seem daunting, it also offers sponsors opportunities to differentiate themselves and gain a competitive edge.
Building Strategic Partnerships: Working with experienced customs brokers, regulatory consultants, and logistics providers can simplify the import process and reduce delays. These partnerships allow sponsors to focus on the trial while experts handle the complexities of importation.
Preparing for Success: Sponsors who invest time in understanding Brazil’s regulatory and logistical landscape are better positioned to avoid costly mistakes. Detailed planning, including early documentation preparation and proactive communication with authorities, can significantly streamline the process.
Despite the importation challenges, Brazil remains an attractive destination for clinical trials. Sponsors who successfully navigate the import process gain access to a market with immense potential for growth and innovation.
By understanding the intricacies of Brazil’s import requirements and planning accordingly, sponsors can unlock the opportunities this vibrant market offers. While the road may be complex, the destination is undoubtedly rewarding.
Brazil’s Key Strengths in Diversity and Patient Recruitment
Brazil’s diverse population, with over 50% of its people claiming multiple ethnic origins, provides a unique advantage for clinical trials. (24) Moreover, Brazil boasts a well-established patient recruitment infrastructure. Clinical research organizations (CROs) and patient advocacy groups have developed effective strategies for identifying and engaging potential trial participants. (25) The country’s extensive public health system, SUS, facilitates efficient patient recruitment with high retention rates. (5) This efficient recruitment process allows researchers to complete studies faster and with lower dropout rates.
Patient Recruitment and Demographics
Brazil’s success in clinical trials is primarily attributed to its robust patient recruitment strategies and unique demographic advantages. The country’s population of over 215 million people represents a vast and diverse pool of potential trial participants, offering researchers access to a wide range of genetic backgrounds, socioeconomic statuses, and disease profiles. (1)
One of Brazil’s key strengths lies in its genetic diversity. The population results from centuries of intermarriage between indigenous peoples, European colonizers, African slaves, and later waves of immigrants from Asia and the Middle East. (26) This genetic melting pot provides an ideal setting for medical device studies, enabling researchers to recruit from a diverse pool of patients with a wide range of health conditions. This diversity is crucial for evaluating the effectiveness of devices related to cardiovascular health, orthopedic issues, and neurostimulation, ensuring that studies reflect the varied responses across different demographic groups. Brazil faces a high burden of both communicable and non-communicable diseases. For instance, cardiovascular diseases, diabetes, and cancer are prevalent, making it easier to find patients for trials targeting these conditions. (24) The high prevalence of these diseases ensures a steady stream of eligible participants for relevant clinical trials.
Brazil’s patient recruitment strategies are multifaceted and leverage both traditional and innovative approaches:
Public Health System Integration: The SUS is crucial for patient recruitment. Its extensive network of hospitals and clinics serves as a primary source for identifying potential trial participants across various medical conditions. (27)
Patient Registries: Brazil has developed comprehensive patient registries for various diseases, particularly in oncology and rare diseases. These registries facilitate the identification of eligible participants for specific trials. (28)
Community Engagement: CROs and research institutions in Brazil often engage with local communities through health fairs, educational programs, and partnerships with patient advocacy groups. This grassroots approach helps build trust and increases awareness about clinical trials. (29)
Digital Recruitment: With the increasing penetration of smartphones and internet access, Brazil has seen a rise in digital recruitment strategies. Social media campaigns, online patient communities, and mobile health apps are used to reach potential participants, especially younger demographics.
Diverse Site Selection: Research centers are strategically located across different regions of Brazil to ensure representation from various demographic groups, including urban and rural populations. (30)
The effectiveness of these strategies is evident in Brazil’s high patient retention rates. A Brazilian clinical research institute study found that participant retention in Brazilian trials was 15% higher than the global average, attributed to patient-physician solid relationships and comprehensive follow-up procedures. (31)
Brazil’s demographic diversity also allows for the conduct of trials that require specific population subsets:
Rare Diseases: Brazil’s large and diverse population increases the likelihood of finding patients with rare genetic conditions, making it an attractive location for orphan drug trials. (32)
Pediatric Studies: Brazil’s relatively young population, about 24% under 14, provides ample opportunities for pediatric clinical research. (33)
Geriatric Research: With a rapidly aging population, Brazil is also becoming a key site for trials focused on age-related conditions and geriatric medicine. (34)
However, challenges remain in ensuring equitable representation across all demographic groups. Efforts are ongoing to improve recruitment from Indigenous communities, rural areas, and lower socioeconomic groups historically underrepresented in clinical trials. (35)
Brazil’s diverse population, innovative recruitment strategies, and high retention rates combine to position the country as a premier destination for clinical trials, seeking to generate globally relevant and inclusive data.
Comparison of Brazil’s Clinical Research Landscape to Other Latin American Countries
While other Latin American countries demonstrate potential for clinical research growth, Brazil holds a competitive advantage. Compared to Argentina, Colombia, and Mexico, Brazil offers a more extensive and diverse population, a more established network of research centers, and a more streamlined regulatory framework under Law 14.874/24. (31) (36) (37)
Argentina has long been known for its oncology trial expertise, which solid academic institutions and a well-established regulatory framework support. The country benefits from rapid trial approvals, which can take as little as three months. (38) However, Argentina’s patient population is less diverse than Brazil's, limiting its appeal for genetic variability trials.
Colombia has made considerable progress in clinical trials over the last decade, thanks to its growing number of accredited research sites and a highly skilled workforce. Colombia has positioned itself as a cost-effective alternative for clinical trials in Latin America, with 6–9-month trial approval timelines. However, it lacks the same level of infrastructure and experience that Brazil offers in larger-scale Phase III studies. (28)
Mexico is another competitor, particularly for medical device trials, but it faces challenges related to the slow regulatory approval process and fragmented healthcare system. While Mexico has demonstrated strong growth in clinical research, Brazil’s infrastructure and new regulatory framework give it a competitive edge in attracting more complex and high-value trials. (8)
To provide a more comprehensive comparison, specific metrics across these countries reveal:
As of 2024, Brazil leads Latin America with 4,500 active clinical trials, surpassing Argentina with 2,800, Mexico with 2,300, Colombia with 1,900, and Chile with 1,200. (39) (40) (41) (42) (43)
Regulatory approval timelines in Brazil are notably efficient, taking between 60 and 90 days under Law 14.874/24. Argentina’s timelines range from 90 to 120 days, Mexico’s from 180 to 240 days, Colombia’s from 180 to 270 days, and Chile’s from 120 to 150 days. (39) (40) (41) (42) (43)
Brazil’s clinical research infrastructure includes over 3,000 accredited research sites, significantly more than Argentina’s 1,500, Mexico’s 1,200, Colombia’s 800, and Chile’s 600. (39) (40) (41) (42) (43)
With a population of 215 million, Brazil offers the largest and most diverse patient pool in the region, compared to Mexico’s 130 million, Colombia’s 51 million, Argentina’s 45 million, and Chile’s 19 million, all of which have lower levels of genetic diversity. (39) (40) (41) (42) (43)
Brazil’s healthcare expenditure as a percentage of GDP is 9.5%, outpacing Argentina at 9.1%, Chile at 9.0%, Colombia at 7.2%, and Mexico at 5.4%. (39) (40) (41) (42) (43)
Brazil accounts for 35% of Latin America’s participation in global multi-center trials, leading the region ahead of Argentina with 22%, Mexico with 18%, Colombia with 12%, and Chile with 8%. (39) (40) (41) (42) (43)
These statistics highlight Brazil’s dominant position in the Latin American clinical research landscape. The country’s large, diverse population, coupled with its extensive network of research sites and improved regulatory framework, positions it as the preferred destination for complex, large-scale clinical trials in the region.
However, each country has unique strengths. Argentina excels in oncology research, while Chile has made significant strides in telemedicine and digital health trials. Mexico’s proximity to the United States offers logistical advantages for particular studies.
Brazil’s new regulatory framework is expected to widen the gap in approval timelines further, potentially attracting more trials that might have previously considered other Latin American countries. Nonetheless, competition is driving improvements across the region, with countries like Colombia and Chile actively working to streamline their approval processes and enhance their research infrastructure.
The collaborative nature of clinical research in Latin America should also be noted. Many multi-center trials span multiple regional countries, leveraging each of their strengths. For instance, a trial might recruit rare disease patients from Brazil’s diverse population, conduct specialized imaging in Argentina’s advanced facilities, and utilize Chile’s expertise in digital health for remote monitoring. (44)
Brazil's leadership position seems secure as the clinical research landscape in Latin America continues to evolve. However, the ongoing improvements across the region promise to elevate the quality and quantity of clinical trials conducted throughout Latin America.
Success Stories and Case Studies
Several high-profile studies and breakthrough innovations exemplify Brazil’s growing prominence in biomedical clinical research. These success stories demonstrate Brazil’s capabilities in conducting complex medical research and highlight the country’s impact on the global research community.
Brain-Computer Interface Trials: The BrainGate-Brazil study at the Federal University of São Paulo (UNIFESP) marked a significant milestone in neurotechnology research. This trial evaluated an advanced brain-computer interface in patients with severe motor disabilities, demonstrating successful neural signal decoding and enabling participants to control digital devices through thought alone. (45) The study's success has positioned Brazil as a key neurotechnology research and development player.
Neurostimulation for Chronic Pain: A multicenter trial led by researchers at Hospital Sírio-Libanês in São Paulo evaluated a novel spinal cord stimulation device for chronic pain management. (46) This study, involving multiple research centers across Brazil, demonstrated significant pain reduction and improved quality of life in patients with failed back surgery syndrome. The trial's success led to ANVISA approval and established a new standard for pain management in Latin America.
Innovative Medical Device: Brain-Computer Interface: Researchers at the Federal University of São Paulo (UNIFESP) have been conducting trials on an advanced brain-computer interface designed to assist patients with severe motor disabilities. (47) This cutting-edge research showcases Brazil’s capabilities in neurotechnology and demonstrates the country’s potential to develop innovative medical devices.
Brazil has also made significant contributions to medical devices and innovations, including:
Diagnostic Devices:
Chest photofluorography: Revolutionized tuberculosis screening, invented by Manuel Dias de Abreu. (48)
Portable retinal diagnosis equipment: Developed by the SENAI Innovation Institute in Pernambuco. (49)
Low-cost isothermal reaction device: A collaboration between SENAI in Manaus and FIOCRUZ, aiding in diagnosing infections like tuberculosis and malaria. (49)
Surgical Procedures:
Jatene procedure: A surgical technique for congenital heart defects, developed by Adib Jatene. (48)
Medical Imaging:
Radiology imaging transmission system: Created by SENAI in Pernambuco. (49)
Leme panoramic camera: Invented by Sebastião Carvalho Leme for medical imaging applications. (48)
Orthopedic and Prosthetic Devices:
SENAI in Rio Grande do Sul develops orthoses, breast prostheses, and various health instruments. (49)
Other Innovations:
Anti-ophidic serum: Developed by Vital Brazil, who also created anti-scorpion and anti-spider serums. (48)
Speech analysis application: A Federal University of Rio Grande do Norte tool for diagnosing schizophrenia. (49)
These case studies illustrate Brazil’s diverse research capabilities, from rapid responses to emerging health threats to long-term studies on endemic diseases and cutting-edge medical technologies. They also highlight Brazil’s ability to contribute meaningfully to global health initiatives while addressing local and regional health priorities.
It's important to note that Brazil is actively expanding its medical device innovation capabilities. The country has established a network of SENAI Innovation Institutes (ISIs) focusing on various health and medical innovation aspects, including microelectronics, information and communication technologies, and advanced materials. These institutes will likely contribute to developing more medical devices in the future. (49)
Historical Growth Trends in Clinical Trials
The growth of clinical trials in Brazil over the past decade reflects the country’s increasing prominence in global medical research. This growth has been driven by a combination of factors, including regulatory improvements, investment in research infrastructure, and Brazil’s inherent advantages in population diversity and healthcare system reach.
In 2010, Brazil hosted approximately 1,500 active clinical trials. (50)
By 2015, this number had grown to around 2,700. (51)
As of 2024, following the implementation of Law 14.874/24, the number of active trials has surpassed 4,500. (39)
Key Drivers of Growth:
Regulatory Improvements: The creation of the National Clinical Research Network (RNPC) in 2005 laid the groundwork for growth. Subsequent improvements, culminating in Law 14.874/24, have progressively streamlined the regulatory process.
Infrastructure Investment: Between 2010 and 2020, Brazil saw a 40% increase in accredited research sites. (51)
International Partnerships: Collaborations with organizations like the NIH and major pharmaceutical companies have increased, bringing more global trials to Brazil. (52)
Regional Distribution:
Clinical trial activity was initially concentrated in the southeast region (São Paulo, Rio de Janeiro), but it has gradually spread to other areas. In particular, the northeast and south regions have seen significant trial activity growth over the past decade. (52)
Industry Involvement:
The proportion of industry-sponsored trials has increased from 60% in 2010 to 75% in 2024, indicating growing interest from life sciences companies. (53)
Economic Considerations for Medical Device Clinical Trials in Brazil
This historical trend demonstrates Brazil’s evolution from a predominantly late-phase trial destination to a comprehensive research hub supporting all phases of clinical development. Despite global challenges, consistent growth underscores Brazil’s resilience and increasing importance in the global clinical trial landscape.
Brazil offers a cost-effective solution for medical device clinical trials, providing high-quality data at a lower cost compared to the U.S. and Western Europe. A 2023 report indicates that the average cost per patient in Brazilian medical device trials is 25-35% lower than in the U.S., largely due to reduced operational expenses, including labor and site management fees. (54) (55) Site fees and investigator payments are similarly reduced by 20-30%, resulting in significant savings for sponsors. (56)
Recruitment in Brazil benefits from the extensive public healthcare system (SUS), allowing faster access to a diverse patient population. Recruitment is typically 15-20% quicker than in North America, a significant advantage for medical device trials where patient availability can be critical. (40) (57) Moreover, Brazil’s patient retention rates, 10-15% above global averages, further cut costs by minimizing re-recruitment needs. (54) (57)
Brazil's costs are higher than those of other emerging markets like India and China, but the country aligns better with global regulatory standards, particularly the ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. (54) Brazil’s costs remain comparable to those of Eastern European countries, traditionally viewed as cost-effective trial destinations. (56)
Although Brazil’s regulatory processes may increase initial setup expenses, lower operational costs offset these. Additionally, multinational CROs with established infrastructure and government tax incentives offering up to a 34% reduction in corporate income tax for R&D investments enhance Brazil’s appeal for conducting medical device trials. (56) (57)
Brazil offers notable advantages in operational and logistical costs for conducting clinical trials. Expenses related to personnel, facilities, and medical services are generally lower compared to countries like the United States, United Kingdom, Australia, and Canada. This cost differential enables pharmaceutical companies and CROs to optimize their budgets without compromising research quality. (58) (59) (60) (61)
Brazil’s geographical proximity to the United States provides significant logistical benefits. 11 direct flights connecting the United States to Brazil, such as São Paulo and Rio de Janeiro, and U.S. cities like Miami, New York, and Houston. For instance, airlines like American Airlines offer direct flights from Miami to São Paulo. The average duration of a direct flight between São Paulo and Miami is approximately 8 to 9 hours, facilitating swift travel for personnel involved in clinical trials. (62)
Brazil’s proximity to the United States allows for more frequent and efficient interactions between sponsors and CROs or research sites. This closeness enables regular visits, effective oversight, and direct communication, all of which are crucial for successful clinical trials. Additionally, the similar time zones between the two countries contribute to more efficient coordination of activities and meetings.
When planning clinical trials in Latin America, one critical factor often overlooked is the cost of living in the host country. A higher cost of living directly impacts operational budgets, driving up salaries, medical services costs, and operational overheads, making trials more expensive. In this context, Brazil emerges as a strategic option, offering a competitive cost of living without compromising on quality.
Brazil’s cost of living—a manageable $754 per month— is a pivotal advantage, particularly compared to high-cost markets. Here’s how living costs (monthly average) vary across key Latin American countries, showcasing why Brazil strikes a balance between affordability and quality:
Panama: $1,198 – The highest in the region, driven by its use of the U.S. dollar and elevated living standards. While this adds stability to economic transactions, this translates into significantly higher salaries and healthcare expenses.
Chile: $936 – While it offers strong infrastructure, the higher living costs elevate operational expenses.
Mexico: $889 – Affordable for housing and food, but salaries and medical services are moderately high.
Brazil: $754 – A cost-effective option with competitive salaries and medical service costs.
Colombia: $735 – Slightly lower than Brazil, with similar economic dynamics.
Argentina: $563 – The lowest in the region, but currency volatility can complicate budgeting.
With a cost of living below that of Chile and Panama, Brazil offers competitive but not prohibitive salaries. This allows companies to access skilled professionals without the financial strain of high-wage demands. Brazilian healthcare services, while advanced, remain cost-efficient compared to high-cost countries. This is vital for managing trial budgets, especially in studies requiring extensive patient care or specialized procedures. Daily operational expenses, such as transportation and researcher accommodations, are more affordable in Brazil than in other countries with similar infrastructure and capabilities. Brazil’s lower cost of living helps control these expenses without sacrificing access to state-of-the-art facilities and experienced professionals. By reducing these overheads, sponsors can allocate resources more effectively to other critical aspects of the trial, such as patient recruitment or advanced testing. (63) (64) (65) (66)
In summary, Brazil is an attractive option for conducting clinical trials due to its cost efficiency, logistical advantages, and the ability to maintain close and effective relationships with CROs and research sites.
Advocacy Efforts for Clinical Research in Brazil
The advancement of clinical research in Brazil is not solely driven by legislation. Industry associations such as the Brazilian Association of Clinical Research Companies (ABRACRO), (12) the National Chamber of Research Entities and Contract Research Organizations (CAEME/CAOIC), and the Brazilian Medical Device Industry Association (ABIMED) play crucial roles in advocating for a more favorable regulatory environment.
These organizations collaborate with government agencies and regulatory bodies to develop and implement policies that promote ethical research while facilitating industry growth. Their efforts include:
Public Discussions: Engaging with regulators from ANVISA, central and local ethics committees, and other sectorial associations to foster dialogue and improve regulations.
Training Programs: Extension courses on clinical research are conducted to support the entry of new professionals and the upskilling of existing ones, with a specialized focus on medical device investigation protocols. (67)
Regulatory Alignment: Pushing for alignment with international standards, such as those set by the FDA and the European Medicines Agency (EMA), to ensure that clinical data generated in Brazil is accepted by reference regulatory authorities worldwide, especially for novel medical devices and combination products. (68)
ABIMO and ABIMED are also key organizations within Brazil’s medical device industry, each with distinct roles and focus areas:
ABIMO (Brazilian Association of Medical, Dental, Hospital, and Laboratory Equipment Industries): This organization primarily advocates for Brazilian medical device manufacturers, aiming to strengthen the domestic industry. ABIMO promotes innovation, improves production capabilities, and fosters international competitiveness for locally produced medical devices.
ABIMED (Brazilian Association of High Technology Health Products): In contrast, ABIMED represents the interests of medical device importers. The organization ensures a favorable regulatory and business environment for international companies supplying advanced medical technologies to the Brazilian market.
While both entities contribute to the growth of Brazil’s healthcare sector, their distinct priorities—supporting domestic manufacturing rather than facilitating imported technologies—highlight their complementary roles in addressing the industry's diverse needs. (69) (70)
Conclusion
Brazil is on the brink of a transformative era in medical device clinical research, driven by the recent enactment of Law 14.874/24. This landmark legislation streamlines regulatory processes, enhances patient protection, and encourages innovation, positioning Brazil as a leading destination for complex clinical trials in Latin America.
The country's diverse population and extensive healthcare infrastructure offer unparalleled inclusive and representative research opportunities. As Brazil continues attracting international investment and fostering collaborations with global research entities, it can benefit from an influx of innovative medical technologies addressing local and global health challenges.
Brazil’s research landscape faces unique challenges, especially due to ANVISA, which has strict requirements for medical device trials. These requirements include complex documentation and approval processes that can lead to delays, with medical device CROs assisting companies in mitigating these administrative hurdles. Despite facing challenges, such as regional disparities in healthcare access, Brazil's commitment to improving its research landscape is unwavering. The proactive efforts of industry associations and the government to align with international standards further solidify its competitive edge.
In conclusion, Brazil's strategic investments in clinical research promise to enhance its healthcare outcomes and contribute significantly to the global medical community. As the landscape evolves, Brazil is poised to emerge as a hub for pioneering medical device research, driving advancements that will resonate far beyond its borders.
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