Navigating Brazil's Medical Device Clinical Trial Import Process

By Julio G. Martinez-Clark, CEO, bioaccess

When medtech sponsors plan clinical trials in Brazil — a market of over 215 million people with advanced research infrastructure — they often focus on recruitment timelines, regulatory approvals, and cost efficiency. Yet many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

Brazil's import process is structured but complex. A shipment of medical devices destined for a clinical trial site in São Paulo must navigate multiple regulatory agencies, customs clearance channels, and logistical considerations that can unpredictably extend timelines. For sponsors unfamiliar with the system, this represents a hidden risk. For those who master it, it becomes a competitive advantage.

Understanding the nuances of Brazil's import process isn't just about avoiding delays — it's about strategically planning your trial timeline and operational budget. With the recent passage of Law 14.874/24, which has streamlined clinical trial approvals to approximately 60 days, sponsors who can accelerate their material importation will unlock real time to market advantages.

This article examines the structured yet intricate import process, identifies key challenges, and outlines practical strategies for sponsors to navigate this landscape effectively.

Importing clinical trial materials into Brazil is not straightforward, even for non-commercial samples. The process involves several key regulatory and logistical steps that must be executed in proper sequence, as defined by Brazil's comprehensive regulatory framework encompassing Law 14.874/24, Decree 6.759/2009, and ANVISA's technical guidelines.

SISCOMEX Registration. The first step is to register with SISCOMEX (the Integrated Foreign Trade System), Brazil's electronic system for managing all foreign trade operations.¹ This registration can take anywhere from a few days to several weeks, depending on documentation accuracy and government workload. Sponsors or their customs brokers must establish an account and input detailed information about the importer and the goods being imported. Delays at this stage cascade downstream, affecting all subsequent approval steps.

RADAR License Acquisition. Next, importers must secure a RADAR license (Registro e Rastreamento da Atuação dos Intervenientes Aduaneiros) — essentially a registration credential for customs operators.² Companies can pursue RADAR licensing directly, but the process often takes weeks for approval. Alternatively, sponsors may delegate importation to third-party customs brokers who already hold RADAR licenses, though this adds a layer of outsourced dependency to your timeline and costs.

Ministry of Health Import License. An import license from Brazil's Ministry of Health is mandatory for all clinical trial materials.³ Obtaining this license can require seven to 45 days, depending on the Ministry's current workload and the completeness of submitted documentation. For time-sensitive trials, this window represents a significant planning variable.

ANVISA Regulatory Approval. The National Health Surveillance Agency (ANVISA) must approve all imported clinical trial materials to ensure compliance with health and safety standards, as specified under RDC 208/2018, RDC 81/2008, and RDC 837/2023.⁴ This regulatory gate-keeping adds two to four weeks to the timeline, particularly if the agency requests clarifications on product specifications or usage protocols.

Customs Clearance. The final step involves Brazil's customs process, which assigns shipments to one of four clearance channels: green (no inspection), yellow (document review), red (physical inspection), or grey (detailed inspection and valuation analysis).⁵ The assignment is often opaque and depends on customs officers' risk assessment. A shipment flagged for physical inspection or valuation can remain in customs for weeks or even up to 120 days, creating unpredictable delays that few sponsors anticipate.

In total, the import process — from SISCOMEX registration to final customs clearance — can span anywhere from four weeks to five or more months depending on the complexity of your shipment and the efficiency of each agency.

Documentation Requirements

Brazil's import process demands extensive documentation, and incomplete paperwork is the primary cause of delays. Required documents include import licenses, certificates of analysis, technical specifications, manufacturer information, and detailed descriptions of the materials being imported.⁶ For medical devices, ANVISA requires additional technical files and quality control certifications per Normative Instruction SRF 680/2006.

Many sponsors underestimate the granularity of documentation needed. A missing serial number, an incomplete product specification sheet, or an outdated certificate of analysis can halt the process and trigger resubmission requests. Each request adds two to three weeks to the timeline.

Regulatory Complexity

ANVISA's regulations for medical devices are sophisticated and rigorous — appropriate for a regulatory agency protecting public health in a nation of 215 million people. However, the regulatory requirements for imported clinical trial materials are not always clearly articulated, particularly for device types that are novel or represent emerging technologies.⁷ Sponsors unfamiliar with ANVISA's interpretation of regulations often find their submissions rejected with requests for clarification that require significant rework.

Logistics and Geographical Challenge

Brazil's vast geography — roughly the size of the continental United States — means that transporting materials from ports to trial sites across the country is a multi-modal logistical challenge. Approximately 60 percent of goods in Brazil move by road, and heavy rains in certain seasons can disrupt transportation routes, especially in the Northeast and North regions.⁸ A shipment cleared in Port of Santos (serving São Paulo) may take two to three weeks to reach a trial site in interior locations, depending on seasonal conditions.

Customs Channel Assignment and Delays

The customs clearance channel assignment process lacks transparency. A shipment may be assigned to the green channel (no inspection, typically 24 to 48 hours) or the red channel (physical inspection, potentially 10 to 20 days) based on risk factors that are not disclosed to importers. Shipments flagged for valuation analysis — customs' assessment of declared product value — can face delays exceeding 120 days as officials verify that the import price aligns with comparable global market rates.⁹

Rather than accepting these complexities as unavoidable, forward-thinking sponsors are transforming them into strategic advantages.

Building Strategic Partnerships

The most effective approach is to partner early with experienced customs brokers, regulatory consultants, and logistics providers who possess specialized expertise in Brazil's import landscape.¹⁰ These professionals bring multiple advantages: deep knowledge of ANVISA's regulatory expectations and technical requirements, established familiarity with customs procedures and documentation standards, and proven processes for coordinating across the multiple agencies involved in the import clearance process.

An experienced customs broker can help optimize documentation to increase the likelihood of green channel customs assignment. They also maintain operational knowledge of port procedures and can identify efficient pathways through customs processing. Regulatory consultants with ANVISA experience can proactively address regulatory questions during the submission phase, reducing the back-and-forth communication that often extends timelines.

Proactive Documentation Preparation

Sponsors who invest in detailed, accurate documentation up front see dramatically faster approvals. This includes:

• completing all required forms in Portuguese and English versions, with careful attention to technical specifications and product descriptions
• obtaining certificates of analysis from manufacturers well in advance, rather than scrambling to collect them days before import
• creating a regulatory dossier that includes all technical information ANVISA might request, submitted proactively rather than in response to queries
• engaging with regulatory experts who can guide submission strategy and identify potential issues before formal submission to ANVISA.

Strategic Port and Logistics Planning

Not all Brazilian ports are equally efficient. Port of Santos (near São Paulo) is the largest and most experienced with medical device imports, benefiting from superior infrastructure and customs clearance processes; the ports of Rio de Janeiro, Paranaguá, and Salvador also handle these shipments regularly. Routing shipments through experienced ports, even if it means slightly longer inland transportation, can reduce customs processing time. Additionally, for sponsors utilizing air cargo, Viracopos International Airport (VCP) in Campinas, São Paulo State, offers a specialized cold storage complex and customs procedures considered among Brazil's most efficient, making it an increasingly attractive alternative to traditional seaports for temperature-sensitive medical devices.

Additionally, sponsors should coordinate with logistics providers to understand seasonal transportation challenges and regional climate conditions. Shipments destined for trial sites in the North or Northeast regions should account for rainfall seasons (May-August) when road transportation is frequently delayed. Equally important is maintaining appropriate storage conditions during transit — Brazil's tropical and subtropical climate in these regions requires careful attention to temperature and humidity control, particularly for devices with strict manufacturer specifications. This consideration should inform the choice between maritime, air, or combination transportation strategies.

Trial Timeline Integration

Perhaps most importantly, successful sponsors integrate import planning directly into their trial timeline projections. Rather than treating importation as an administrative task handled after clinical trial approval is granted, they work backward from their intended trial start date.

If a trial is scheduled to begin on March 1, and the import process requires 10 to 12 weeks, importation planning must commence in December. This backward scheduling forces earlier engagement with customs brokers, earlier preparation of documentation, and earlier submission of regulatory requests — all of which increase the likelihood of meeting the target date.

Brazil's new regulatory environment, created by Law 14.874/24, has compressed clinical trial approvals to approximately 60 days, with 30-day ethics committee reviews and 90-day ANVISA reviews conducted in parallel.¹¹ This acceleration creates a paradox: regulatory approvals are faster, but material importation timelines haven't accelerated proportionally.

Sponsors who can synchronize material importation with regulatory review — beginning import procedures at the same time regulatory submissions are made — will eliminate a traditional sequential bottleneck. This requires close coordination between your regulatory, quality, and logistics teams, but it can shave four to six weeks off a trial's total launch timeline.

Brazil's import process for clinical trial materials is structured, transparent, and navigable — but only for sponsors who approach it strategically. The process involves multiple agencies, each with distinct requirements and timelines, but none is unreasonably burdensome. The challenge is coordinating across them effectively and engaging with professionals who understand the regulatory expectations and logistical realities of Brazil's import environment.

For sponsors who master Brazil's import landscape, the payoff is clear: faster trial launches, more predictable timelines, and operational cost control. As Brazil's regulatory environment continues to accelerate under Law 14.874/24, sponsors who eliminate material importation bottlenecks will gain a measurable competitive advantage.

The question is not whether the import process can be navigated — it can be. The question is whether your team has the strategic planning and local expertise to navigate it efficiently. In a market as attractive as Brazil, the answer increasingly determines trial success.

1. Integrated Foreign Trade System (SISCOMEX). Government of Brazil. (2024). SISCOMEX Operational Manual. Brazilian Federal Revenue Service. https://www.gov.br/receita/pt-br/assuntos/siscomex
2. Customs Operations Register and Tracking System (RADAR). Government of Brazil. (2024). RADAR License Requirements and Application. Brazilian Federal Revenue Service. https://www.gov.br/receita/pt-br/assuntos/aduaneira
3. Ministry of Health. (2024). Import License Procedures for Clinical Trial Materials. Brazilian Ministry of Health, ANVISA. https://www.anvisa.gov.br/
4. National Health Surveillance Agency (ANVISA). (2024). Medical Device Import Approval Process and Timeline. Brazilian Federal Government. https://www.anvisa.gov.br/medicamentos/import; ANVISA. (2023). Resolução RDC 837/2023: Investigações Clínicas com Dispositivos Médicos. https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=
   RDC&numeroAto=00000837&seqAto=000&valorAno=2023&orgao=RDC/DC/ANVISA/MS
5. Federal Revenue Service. (2024). Brazilian Customs Clearance Channels: Risk Assessment and Processing. Government of Brazil. https://www.gov.br/receita/pt-br/assuntos/aduaneira
6. Ministry of Health & ANVISA. (2023). Technical Documentation Requirements for Imported Medical Devices. Brazilian Ministry of Health. https://www.anvisa.gov.br/; Brazilian Federal Revenue Service. (2006). Instrução Normativa SRF nº 680/2006. https://normasinternet2.receita.fazenda.gov.br/#/consulta/externa/15618/visao/multivigente
7. ANVISA. (2024). Regulatory Guidance on Clinical Trial Medical Device Importation. National Health Surveillance Agency. https://www.anvisa.gov.br/medicamentos/import; ANVISA. (2008). Resolução RDC 81/2008: Regulamento Técnico de Bens e Produtos Importados para fins de Vigilância Sanitária. https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=
   RDC&numeroAto=00000081&seqAto=000&valorAno=2008&orgao=RDC/DC/ANVISA/MS
8. Brazilian Institute of Geography and Statistics. (2023). Transportation Infrastructure and Seasonal Logistics in Brazil. IBGE. https://www.ibge.gov.br/
9. Federal Revenue Service. (2024). Customs Valuation Analysis: Procedures and Timeline. Government of Brazil. https://www.gov.br/receita/pt-br/assuntos/aduaneira; Government of Brazil. (2009). Decreto 6.759/2009: Regulamenta a Administração das Atividades Aduaneiras. https://www.planalto.gov.br/ccivil03/ato2007-2010/2009/decreto/d6759.htm
10. Brazilian Association of Clinical Research Companies (ABRACRO). (2024). Best Practices for Customs Brokerage and Import Coordination. ABRACRO. https://www.abracro.org.br/
11. Law 14.874/24. (2024). Clinical Research Law of Brazil: Lei sobre Pesquisa com Seres Humanos. Official Gazette of the Union. https://www.planalto.gov.br/ccivil03/ato2023-2026/2024/lei/l14874.htm; ANVISA. (2024). Resolução RDC 945/2024: Diretrizes para Ensaios Clínicos. https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=
    RDC&numeroAto=00000945&seqAto=000&valorAno=2024&orgao=RDC/DC/ANVISA/MS

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 Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).