When a global medical device manufacturer partners with a Brazilian company to register a product, one question surfaces with immediate urgency: “Will my confidential technical dossier stay confidential once we file it with Brazil’s National Health Surveillance Agency (ANVISA)?”
The concern is valid. The technical dossier, or Dossiê Técnico, contains a company’s most sensitive intellectual property—from proprietary design specifications and manufacturing processes to preclinical and clinical data. Protecting this information is paramount.
This report provides a definitive guide for regulatory affairs managers, in-house counsel, and business development executives on how ANVISA’s framework protects confidential data. It answers the three most critical questions about data access, communication protocols, and the mechanics of sharing data with a commercial partner, using a recent inquiry from Quest Diagnostics as a practical framework.1
This guide details how foreign medical device manufacturers can protect their intellectual property when registering products in Brazil. It explains that ANVISA's system is designed for confidentiality, strictly limiting access to a manufacturer's complete technical file to the agency itself and the manufacturer's appointed Brazilian Registration Holder (BRH). All official communication must flow exclusively through the BRH. The report provides a deep dive into the Right of Reference (Carta de Autorização) mechanism, which allows commercial partners to use regulatory data without accessing the confidential file, but highlights the critical "agent lock-in" rule that can create commercial traps. The strategic selection of an independent BRH is identified as the single most important decision for maintaining regulatory control and commercial flexibility. Finally, the guide covers key regulatory updates for 2024-2025, including ANVISA's new Reliance pathway and UDI system, which aim to streamline market access while maintaining rigorous oversight.
The foundational principle of ANVISA's system is the controlled and limited access to a manufacturer's proprietary data. Understanding who can—and, more importantly, who cannot—view your complete technical file is the first step to navigating the Brazilian market with confidence.
The Dossiê Técnico is the comprehensive technical file that serves as the basis for a medical device's market authorization in Brazil. It contains the entirety of a device's proprietary information, including but not limited to 2:
Under the pivotal regulation RDC 751/2022, which came into effect in March 2023, the structure of the Dossiê Técnico was officially aligned with the Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) from the International Medical Device Regulators Forum (IMDRF).4 This harmonization significantly reduces the administrative burden for manufacturers who are already preparing submissions for other major global markets that follow the same IMDRF or similar Common Technical Document (CTD) structure.5
Access to the full Dossiê Técnico is strictly limited to a need-to-know basis within the regulatory framework. There are only two entities that can view the complete file during the submission process 1:
This leads to the most critical point for foreign manufacturers concerned about their IP: the commercial partner or client whom a manufacturer authorizes to use the data for a local registration does not gain automatic access to the dossier. They are a third party to the official regulatory submission and can only view the file if the manufacturer chooses to share it with them directly, completely outside of the ANVISA process.1
While the core Dossiê Técnico is confidential, ANVISA does make certain high-level information public. The agency may release a "Summary of Product Characteristics" or similar public-facing documents. However, these documents never contain the underlying proprietary data from the technical file.1
Furthermore, as Brazil implements its Unique Device Identification (UDI) system under RDC 591/2021, certain data points will become publicly accessible through the forthcoming SIUD database. This information typically includes mandatory fields like the legal manufacturer, catalog number, and GMDN code.9 This is standard device identification data designed to enhance traceability and post-market surveillance; it does not include the sensitive design, performance, or manufacturing data that constitutes a company's core IP.
The architecture of ANVISA's regulatory system is deliberately structured to create a firewall between a manufacturer's intellectual property and its commercial partners in Brazil. This is not an accidental feature but a core design principle. The logic is straightforward:
This tripartite structure—Manufacturer, BRH, and Commercial Partner—establishes a natural separation of duties and access. The manufacturer controls the flow of its IP to its commercial partners through direct agreements, while the BRH controls the flow of the official regulatory file to ANVISA. This ensures that the confidentiality of the dossier is maintained throughout the official registration process.
Understanding the strict, unalterable channels of communication with ANVISA is as critical as understanding data access rules. Failure to respect these protocols can lead to significant delays and complications in the review process.
ANVISA's communication policy is absolute: the agency corresponds solely and exclusively with the Brazilian Registration Holder (BRH). All official communications—including deficiency letters (exigências), requests for additional information, and final approval or rejection notices—are directed only to the legally appointed BRH domiciled in Brazil.1
Foreign manufacturers, regardless of their size or global standing, cannot communicate directly with ANVISA reviewers or staff. This is a non-negotiable rule rooted in Brazilian regulatory law, which requires a local entity to be legally responsible for the product on the market.3 Any attempt to bypass the BRH will be ignored.
The "BRH-Only" rule creates a mandatory communication relay that must be managed effectively. A typical exchange during the review process follows these steps 1:
This multi-step process is required for every single official interaction with the agency.
To provide at-a-glance clarity, the following table outlines the specific roles and permissions of each party in the communication loop.
The mandatory communication relay through the BRH is not merely an administrative formality; it is a critical path dependency that introduces a time lag into the review cycle. This "extra hop" must be proactively managed and factored into all project timelines.
Consider a common scenario: ANVISA issues a deficiency letter and gives the BRH a 30-day window to respond. This deadline is for the BRH, not the foreign manufacturer. The clock starts ticking the moment the BRH receives the notice. The BRH must then transmit the query to the manufacturer, who must prepare a comprehensive technical response, which may require input from R&D, quality, and clinical teams. The completed response must then be sent back to the BRH, who needs time to review, format, and submit it before the 30-day deadline expires.
Effectively, a 30-day response window from ANVISA might only translate to a 20- or 25-day window for the manufacturer to do the substantive work. Companies that fail to account for this built-in delay in their internal planning will consistently find themselves rushing to meet deadlines, increasing the risk of incomplete responses and potentially causing their application to be rejected or moved to the back of the review queue. A highly efficient and communicative BRH is essential to minimize this friction.
For a manufacturer that wants to allow a Brazilian partner to commercialize its device without handing over its entire confidential dossier, ANVISA provides a clear and robust mechanism: the Right of Reference (RoR), executed via a Carta de Autorização. This section details how this process works and highlights a critical procedural rule that has major strategic implications.
This two-step process is the standard and most effective method for protecting IP while enabling commercial partnerships.1
Step 1: File a Confidential Master File
The foreign manufacturer, through its chosen BRH, submits the complete Dossiê Técnico to ANVISA. This submission is registered under the manufacturer's name and serves as a confidential "master file" held securely within ANVISA's system.
Step 2: Issue a Carta de Autorização
The manufacturer then drafts a Carta de Autorização. This is typically a simple, one-page Letter of Authorization, also known as a Right of Reference (RoR) letter. This letter explicitly authorizes a specific Brazilian partner/client to reference the data contained within the manufacturer's confidential master file to support their own product registration application.1
The partner's BRH then submits a separate application for the device, attaching the Carta de Autorização as part of the submission package. This letter acts as a key, unlocking ANVISA's ability to cross-reference the technical data in the master file to assess the partner's application. The partner itself never sees or possesses the confidential dossier.
The mechanics of this process are straightforward 1:
While the RoR process is elegant, it is governed by one simple but profoundly important rule: the same Brazilian Registration Holder (BRH) must be the holder of the manufacturer's master file registration and the submitter of the partner's application that references it.1
The consequence of this rule is significant. A registration in Brazil is tied to the BRH that holds it. It cannot be easily transferred to another BRH as one might transfer assets in a corporate transaction (except in specific cases of mergers or successions, governed by separate rules like RDC 903/2024).10 If a manufacturer wishes to change its BRH for any reason, the new BRH cannot simply take over the existing registration. The entire master file dossier must be re-filed by the new BRH to obtain a new registration under its name. The original registration, held by the former BRH, becomes unusable for referencing by any new partners.
An alternative to the RoR pathway is a joint submission. In this scenario, the manufacturer and its Brazilian partner could sign a single contract with one BRH and file one blended dossier. This avoids the need for a Carta de Autorização but is rarely recommended.1
This approach creates an inseparable regulatory bond between the manufacturer and the partner. It makes it nearly impossible to unwind the partnership, add other distributors, or manage the product's lifecycle independently in the future. The RoR pathway offers far cleaner separation between IP protection and commercial flexibility and is the superior choice in over 90% of cases.
The "agent lock-in" rule, when combined with a poor initial choice of BRH, can transform a simple procedural requirement into a major commercial trap. The logic unfolds as follows:
The manufacturer is now commercially captive. Its ability to expand its distribution network is completely controlled by its original partner. To add or switch distributors, the manufacturer would have to terminate its relationship with the original distributor-BRH, find and appoint a new, independent BRH, and then invest the significant time and resources required to re-file the entire Dossiê Técnico from scratch to establish a new, untethered master file registration. This situation gives the original distributor-BRH immense leverage over the manufacturer's entire Brazilian business strategy.
The preceding sections demonstrate that nearly every critical aspect of navigating ANVISA's system—from IP protection to communication efficiency to commercial freedom—converges on a single entity: the Brazilian Registration Holder. Therefore, the selection of a BRH is not a minor administrative task; it is the foundational strategic decision for any foreign manufacturer entering the Brazilian market.
As mandated by Brazilian law, all foreign companies must appoint a BRH to register and market medical devices in the country.6 The BRH is not merely a mail-forwarding service. They are the legal entity named on your ANVISA registration and are legally responsible for the device's compliance in Brazil. Their role is that of a fiduciary guardian for your regulatory presence. The quality, expertise, and integrity of your BRH will directly impact the speed of your market entry, the security of your IP, and your long-term operational flexibility.
Manufacturers essentially have two models to choose from when appointing a BRH, and the choice has profound consequences.
Independent BRH Model: In this model, the manufacturer contracts a specialized, third-party firm whose sole business is to provide BRH services. This independent BRH holds the registration on behalf of the manufacturer but has no commercial interest in the sale or distribution of the product.7 This model decouples regulatory control from commercial activities. The manufacturer holds the master file registration with the independent BRH and is then free to issueCartas de Autorização to any number of distributors it chooses. Adding, changing, or removing distributors can be done at will, without ever affecting the underlying ANVISA registration.
The strategic trade-offs between the two models are stark. The following table provides a clear comparison to aid in decision-making.
The evidence from ANVISA's regulations and procedures leads to an inescapable conclusion. The choice of a BRH is the single most important decision a medical device manufacturer will make when entering Brazil. The entire framework is built around the central pillar of the BRH.
All of these critical functions—IP protection, communication, and commercial flexibility—are vested in the BRH. A poor choice can create cascading negative consequences across a company's entire Brazilian operation. Conversely, selecting a qualified, independent BRH from the outset mitigates nearly all of the structural risks that ANVISA's system presents to foreign manufacturers, allowing them to maintain control of their assets and their destiny in the market.
The Brazilian regulatory environment is not static. ANVISA is in the midst of a significant modernization effort, aiming to increase efficiency and align with global best practices while retaining its rigorous oversight. Understanding these recent and upcoming changes is crucial for developing a forward-looking market strategy.
Effective June 3, 2024, ANVISA implemented a groundbreaking "Reliance" pathway through Normative Instruction (IN) 290/2024.11 This mechanism allows manufacturers of higher-risk Class III and IV devices to leverage prior market authorization from a recognized Equivalent Foreign Regulatory Authority (AREE) to potentially accelerate their ANVISA review.
The initial AREEs are the regulatory bodies of the four founding members of the former Global Harmonization Task Force (GHTF) 11:
It is critical to understand that this is not an automatic approval or a simple notification. Manufacturers must still submit a complete Dossiê Técnico as required by RDC 751/2022. However, by providing evidence of approval from an AREE, ANVISA can give significant weight to the prior review, which is estimated to reduce its own analysis time by at least 30%, helping to clear the queue for high-risk device submissions.11
The Reliance pathway is part of a broader strategic push toward global harmonization. Two other key regulations underscore this trend:
Brazil is advancing toward full implementation of its Unique Device Identification (UDI) system, which will significantly enhance device traceability and post-market surveillance. Under RDC 591/2021 and the recently updated timelines in RDC 884/2024, manufacturers must assign and register UDI information for all devices sold in Brazil.9
The compliance deadlines are staggered by risk class, beginning with Class IV devices on July 10, 2025.15 Manufacturers will be required to submit UDI data to ANVISA's new database, the
Sistema de Identificação Única de Dispositivos Médicos (SIUD). Notably, the system allows registration holders (BRHs) to authorize third-party users, such as the foreign manufacturer or a consultant, to manage the UDI data submissions, providing some operational flexibility.9
Taken together, these updates reveal a sophisticated strategic pivot by ANVISA. The agency is not abandoning its core principles of sovereign control, exemplified by the immutable role of the BRH. Instead, it is layering modern, efficiency-focused mechanisms on top of its established framework.
Historically, Brazil has been perceived as a complex and slow market due to its unique requirements and lengthy review timelines.16 The 2024-2025 Regulatory Agenda shows that ANVISA has identified this as a barrier to innovation and is actively working to streamline its processes.17 The Reliance pathway allows ANVISA to leverage the intensive work already done by trusted peer agencies, reducing its own review burden without ceding its final decision-making authority.11 Simultaneously, harmonizing technical dossiers and safety requirements lowers the barrier to entry for global companies, making Brazil a more attractive and predictable market.4
Manufacturers should therefore view Brazil not as a static bureaucracy, but as a dynamic regulatory environment in a state of positive evolution. Companies that already hold approvals from the US, Canada, Australia, or Japan are now at a distinct advantage. The overarching trend is toward a more efficient and globally integrated, albeit still rigorous, regulatory system.
Synthesizing the analysis, this checklist provides a practical, step-by-step guide for manufacturers planning a secure and successful market entry into Brazil.
ANVISA's regulatory system is not a black box. It is a structured, rules-based framework that, when properly understood, offers robust and predictable protections for a foreign manufacturer's intellectual property. The system is architecturally designed to separate regulatory control from commercial partnerships, creating a natural firewall that safeguards a company's most valuable data assets.
The key to unlocking this system lies in recognizing and respecting its central principle: the non-negotiable, fiduciary role of the Brazilian Registration Holder. By making the strategic decision to partner with a qualified, independent BRH, manufacturers can maintain full control over their registration, ensure efficient communication with the agency, and preserve their commercial flexibility to adapt to market opportunities.
By understanding the "BRH-Only" communication rule, correctly utilizing the Carta de Autorização mechanism, and staying abreast of ANVISA's modernization efforts, global manufacturers can confidently navigate the regulatory process, protect their IP, and successfully access one of Latin America's largest and most important healthcare markets.