Brazil Medical Device Regulations and ANVISA Registration

Brazil is the largest medical device market in Latin America and an important destination for manufacturers seeking international growth. Medical Device Regulations in Brazil require companies to comply with the requirements established by ANVISA, Brazil’s health regulatory authority, before placing a medical device on the market.

The Brazilian regulatory framework is based on a risk-based approach that determines how devices are classified, registered, imported, and monitored throughout their lifecycle. Depending on the product, manufacturers may need to appoint a Brazilian Registration Holder (BRH), obtain CBPF (Brazilian GMP) certification, comply with UDI requirements, and meet post-market surveillance obligations.

This guide explains the key regulations, including RDC 751/2022, RDC 848/2024, RDC 591/2021, RDC 665/2022, and IN 290/2024, as well as the registration pathways, documentation requirements, and practical steps needed to obtain and maintain ANVISA approval in Brazil.

Medical devices are regulated by ANVISA, which is responsible for evaluating applications, granting market authorizations, overseeing compliance activities, and monitoring products available on the Brazilian market.

The regulatory requirements that apply to a device depend on factors such as its intended use, level of risk, technology, and whether it incorporates software or wireless communication features.

Medical device regulation in Brazil is not based on a single regulation. Instead, different rules cover different parts of the product lifecycle, from classification and registration to manufacturing quality, traceability, and regulatory review.

While manufacturers do not need to become experts in every regulation, understanding the purpose of the main requirements can make it easier to identify which obligations apply to their products.

The most important regulations include:

• RDC 751/2022 – The main regulation for medical devices. It defines how devices are classified and establishes the requirements for placing a product on the Brazilian market.
• RDC 848/2024 – Updates and clarifies specific requirements introduced by RDC 751/2022.
• RDC 591/2021 – Introduces Brazil’s Unique Device Identification (UDI) system, which helps improve product traceability throughout the supply chain.
• RDC 665/2022 – Establishes the Good Manufacturing Practice (GMP) requirements that manufacturers must follow to demonstrate consistent product quality and safety.
• IN 290/2024 – Creates a reliance-based review pathway that may allow ANVISA to consider assessments already performed by certain recognized foreign regulatory authorities.

Together, these regulations establish the framework that manufacturers must follow to obtain, maintain, and manage medical device authorization in Brazil.

Software products and in vitro diagnostic devices are also subject to ANVISA oversight. Depending on the product’s intended purpose and associated risks, additional classification rules, technical documentation requirements, or regulatory pathways may apply.

Understanding which regulations apply to your product will help you determine the correct classification, documentation requirements, and registration strategy discussed in the next sections.

One of the first decisions manufacturers must make is determining the correct classification for their device. In Brazil, the classification assigned by ANVISA influences the registration pathway, the level of regulatory scrutiny, and the documentation required to support the application.

This section explains how medical devices are classified, when a product follows the Notification (Notificação) or Registration (Registro) pathway, and how software products fit within the Brazilian framework.

Under RDC 751/2022, medical devices are classified according to the level of risk they present to patients and users. The higher the risk, the more evidence and regulatory controls are generally required.

Brazil uses four risk classes:

The classification is determined by factors such as the device’s intended purpose, duration of use, level of invasiveness, whether it delivers medicinal substances, and the potential impact on patient health if the device fails.

Because the classification drives the entire regulatory strategy, it should be confirmed before any submission activities begin.

Once the device has been classified, the next step is determining the applicable authorization pathway.

In general, Class I and Class II devices follow the Notification (Notificação) pathway, while Class III and Class IV devices require Registration (Registro).

Notification is typically used for lower-risk products and involves a simplified regulatory process. Registration applies to higher-risk devices and requires a more comprehensive review of the technical documentation submitted to ANVISA.

Choosing the wrong pathway can lead to delays, additional questions from ANVISA, or the need to resubmit the application. For this reason, classification and pathway selection are often reviewed together.

Software can also qualify as a medical device in Brazil when it is intended for medical purposes such as diagnosis, monitoring, prediction, treatment support, or clinical decision-making.

Like traditional medical devices, software products are classified according to risk. The classification depends on how the software is used, the information it provides, and the potential consequences of an incorrect result or system failure.

Because software products often combine medical, digital, and cybersecurity considerations, manufacturers should carefully assess the applicable requirements before selecting a registration pathway.

Understanding the regulatory framework is only the first step. Once the classification and registration pathway have been determined, manufacturers can begin preparing their market entry strategy.

While the exact requirements vary depending on the product, most medical devices follow a similar journey from initial planning to market authorization. The steps below provide a practical overview of the process and highlight the key decisions that can impact timelines, costs, and regulatory success.

Foreign manufacturers cannot register medical devices directly with ANVISA. Instead, they must appoint a Brazilian Registration Holder (BRH), which is a local company legally established in Brazil.

The BRH is responsible for interacting with ANVISA, managing regulatory submissions, and supporting certain post-market activities. In many cases, the BRH is also the importer or distributor, although these roles can be separated depending on the manufacturer’s commercial strategy.

After selecting a BRH, manufacturers should confirm the device classification according to RDC 751/2022.

The classification determines whether the product follows the Notification (Notificação) or Registration (Registro) pathway and influences the level of documentation and regulatory review required. An incorrect classification can lead to delays and additional regulatory questions later in the process.

Certain devices require compliance with CBPF (Certificação de Boas Práticas de Fabricação), Brazil’s Good Manufacturing Practice certification system.

This requirement is particularly important for many higher-risk devices and should be assessed early in the project. Manufacturers that already participate in programs such as MDSAP may be able to leverage existing quality system documentation during the process.

The next step is assembling the documentation required to support the application.

Depending on the device and pathway, this may include product descriptions, intended use statements, risk management documentation, performance and safety evidence, clinical information, labeling, instructions for use, and other supporting records.

Manufacturers using the reliance pathway under IN 290/2024 may also need to provide evidence of authorization from recognized foreign regulatory authorities.

Applications are submitted electronically through Solicita, ANVISA’s online submission platform.

The review process varies according to the classification and pathway selected. During the assessment, ANVISA may request clarifications or additional information before granting market authorization.

Receiving regulatory approval is only part of the process. Manufacturers should also prepare for importation, distribution, and commercialization activities.

Import procedures, customs requirements, and supply chain planning should be considered early to avoid delays once authorization has been obtained.

Manufacturers must ensure that device labeling complies with Brazilian requirements and, where applicable, implement Unique Device Identification (UDI) requirements established under RDC 591/2021.

Proper labeling and traceability are important not only for regulatory compliance but also for post-market monitoring and supply chain management.

Regulatory obligations continue after a device enters the market.

Manufacturers and registration holders must maintain compliance with applicable requirements, monitor product performance, manage complaints, report adverse events when required, and support any necessary corrective actions throughout the product lifecycle.

Obtaining ANVISA authorization does not always mean that all regulatory requirements have been satisfied. Depending on the device’s technology, risk profile, manufacturing arrangements, and communication capabilities, additional approvals or certifications may be required before the product can be commercialized in Brazil.

The following requirements do not apply to every device, but they should be evaluated early in the regulatory planning process to avoid unexpected delays.

Many higher-risk medical devices require compliance with Brazil’s Good Manufacturing Practice requirements.

Compliance is demonstrated through CBPF (Certificação de Boas Práticas de Fabricação), which confirms that the manufacturer’s quality management system meets the standards expected by ANVISA. Because obtaining CBPF can significantly impact project timelines, manufacturers should determine early whether this requirement applies to their product.

Medical devices that incorporate wireless communication technologies may require approval from ANATEL, Brazil’s telecommunications authority.

Products using technologies such as Wi-Fi, Bluetooth, cellular connectivity, or other radiofrequency communication systems are commonly assessed for compliance with Brazilian telecommunications requirements before commercialization.

For eletronic devices, ANATEL approval should be considered as part of the overall market access strategy rather than as a separate activity performed at the end of the project.

Some medical devices are also subject to INMETRO certification requirements.

This typically applies to certain electrical and electromedical products that must demonstrate conformity with applicable safety and performance standards before being placed on the Brazilian market.

Manufacturers should verify whether their device falls within one of the product categories covered by INMETRO regulations, as certification activities may need to be completed alongside the ANVISA registration process.

Manufacturers with existing approvals or certifications may be able to benefit from certain regulatory efficiencies.

For example, participation in the Medical Device Single Audit Program (MDSAP) can support quality system assessments, while the reliance pathway established under IN 290/2024 allows ANVISA to consider evaluations performed by recognized foreign regulatory authorities under specific conditions.

Although these mechanisms do not eliminate regulatory requirements, they may help streamline certain aspects of the review process and reduce duplication of effort.

Obtaining ANVISA authorization is an important milestone, but it is not the end of the regulatory process. Once a device is placed on the Brazilian market, manufacturers and registration holders must continue to meet regulatory requirements throughout the product’s lifecycle.

This includes maintaining registrations, managing changes, monitoring product performance, and taking action when safety issues arise. Understanding these obligations is essential for maintaining market access and avoiding compliance issues.

The time required to obtain market authorization can vary depending on the device classification, the selected pathway, the quality of the submission, and whether additional information is requested during the review process.

Lower-risk devices generally follow a faster process, while higher-risk products typically undergo a more extensive assessment. Manufacturers should also account for activities such as documentation preparation, certification requirements, and import planning when estimating overall project timelines.

Once authorization has been granted, companies are responsible for maintaining the accuracy of their registration information.

Certain changes may require notification to ANVISA or an update to the existing registration. Examples can include modifications to the device, labeling updates, manufacturing changes, or changes affecting the authorized representative or registration holder.

Assessing regulatory impact before implementing a change can help avoid compliance issues and unnecessary delays.

Manufacturers and registration holders are expected to monitor the safety and performance of their products after commercialization.

This includes collecting information from customers, investigating complaints, monitoring adverse events, and identifying potential risks associated with real-world use. These activities form part of Brazil’s Tecnovigilância system and help ensure that products continue to meet safety and performance expectations after market entry.

When a safety issue is identified, manufacturers may need to implement corrective actions to protect users and patients.

Depending on the situation, this can include product corrections, software updates, safety notices, product removals, or recalls. Companies should have internal procedures in place to evaluate incidents, communicate with affected stakeholders, and implement corrective actions when required.

ANVISA maintains the Consulta de Produtos para Saúde database, a public online tool that allows users to verify whether a medical device has been authorized for commercialization in Brazil.

By searching the database, manufacturers, distributors, healthcare professionals, and procurement teams can confirm registration details and verify the regulatory status of a product before purchase, importation, or use.

You can search using different criteria, including:

• The device name
• The ANVISA registration or notification number
• The technical name of the device
• The Brazilian Registration Holder (BRH) company identifier (CNPJ)

The database also displays the status of the authorization. A status of “Válido” (Valid) indicates that the device authorization is currently active, while “Inválido” (Invalid) indicates that the authorization is no longer valid.

This tool is commonly used by manufacturers, distributors, healthcare providers, and procurement teams to verify the regulatory status of a product before importation, purchase, or commercialization.

The following questions address some of the most common concerns from manufacturers preparing to enter the Brazilian market.

Entering the Brazilian medical device market requires more than completing a registration application. Manufacturers must navigate classification rules, documentation requirements, certification obligations, importation considerations, and ongoing compliance activities throughout the product lifecycle.

Whether you are preparing your first ANVISA submission or expanding an existing product portfolio, having a clear regulatory strategy can help reduce delays, avoid unnecessary costs, and accelerate market access.

Easy Medical Device supports manufacturers throughout the regulatory journey, including:

• Regulatory strategy and market entry planning
• Device classification assessments
• ANVISA registration support
• Technical documentation reviews
• Gap assessments and compliance evaluations
• Quality management system support
• Post-market compliance guidance

Our team works with manufacturers worldwide to help them understand regulatory requirements and prepare for successful market entry.

If you are planning to commercialize a medical device in Brazil and would like support with your regulatory strategy, our team can help you evaluate the applicable requirements and identify the most appropriate pathway for your product.

Contact us to discuss your project and explore how we can support your market access objectives in Brazil.