How to register medical devices and IVDs in Brazil

Accessing Brazil's large medical device market means getting regulatory approval from ANVISA (Agência Nacional de Vigilância Sanitária), Brazil's national health regulatory authority. For device manufacturers unfamiliar with the process, ANVISA registration can be daunting. It involves classification decisions, local representation requirements, technical documentation, testing requirements for certain devices, and quality system compliance with Brazilian standards. This article breaks down the steps involved in registering a medical device or IVD with ANVISA so you can approach the Brazilian market with a clear roadmap.

Brazil medical device regulatory overview

The primary regulation for medical devices in Brazil is RDC 751/2022, which addresses medical device classification, notification, and registration processes. For IVDs, RDC 830/2023 consolidated relevant IVD legislation and adopted similar regulatory procedures as RDC 751/2022.

There are two main regulatory pathways for medical devices and IVDs:

• Notification (for lower-risk Class I and II devices): The notification process is a faster review with less documentation. Review timelines for notifications range from 30–45 days and do not expire.

• Registration (for higher-risk Class III and IV devices): Registration is a more rigorous process, including technical dossier submission and, in many cases, Brazil Good Manufacturing Practices (B-GMP) certification, which includes facilities inspections. Reviews for registrations can take 4–12 months or longer, depending on the complexity and risk profile of the device. Registrations must be renewed every 10 years.

Reliance Pathway ANVISA Registrations

Under IN 290/2024, manufacturers of Class III and IV can streamline the ANVISA Registration review process and potentially get to market 30% faster by leveraging authorizations from an Equivalent Foreign Regulatory Authority (AREE). ANVISA recognizes these authorizations from four former Global Harmonization Task Force (GHTF, now IMDRF) members:

• Australia Therapeutic Goods Administration (TGA) — Australian Register of Therapeutic Goods (ARTG)

• Health Canada — Medical Device License (MDL)

• U.S. Food and Drug Administration (US FDA) — 510(k) Clearance, Premarket Approval (PMA), or De Novo classification

• Japan Ministry of Health, Labour and Welfare (MHLW) — Pre-market Approval (shonin)

To be eligible for this route, the device must be "essentially identical" to the product approved by the AREE. The AREE approval cannot be referenced if the AREE authority leveraged any reliance pathways for its review. This pathway is only available to Class III and IV medical devices and IVDs.

It is worth noting that the AREE reliance pathway does not exempt you from any of ANVISA's regulatory or documentation requirements. You must still submit a full technical file, undergo B-GMP certification (though ANVISA may waive the onsite inspection in favor of a desk audit), and secure INMETRO or ANATEL certification, if required. This route merely reduces ANVISA's review burden and shortens the overall approval timeline.

Key steps in the Brazil ANVISA submission process

Some of the steps required for the Brazil medical device registration process include:

• Confirm your medical device or IVD classification. Classification determines the regulatory pathway (notification or registration) for your device, including documentation and QMS requirements. Medical devices and IVDs are both classified into four tiers of increasing risk (Class I, II, III, IV) but are subject to different rules.

• Appoint a Brazil Registration Holder (BRH). Foreign manufacturers must appoint a Brazil-based entity to assume legal responsibility for their product. Your BRH submits your dossier to ANVISA, ensures compliance throughout the lifecycle, and performs all postmarket surveillance and vigilance activities.

• Obtain GMP compliance certification (Class III and IV). Brazil has its own quality management system (QMS) framework established under RDC 665/2022. B-GMP certification is required only for Class III and IV medical devices and IVDs and usually involves an ANVISA inspection of your manufacturing sites. You must obtain your B-GMP certificate from ANVISA before applying for ANVISA Registration.

• Obtain INMETRO, ANATEL, or INCQS certification (if required). Certain devices and IVDs require additional testing and/or certification from Brazil-based authorities based on their functionality (e.g., electrical, wireless, and certain IVDs). This is a separate process that must be completed prior to ANVISA submission and applies to all device classifications.

• Apply UDI to device labeling. ANVISA is rolling out UDI labeling requirements. As of January 10, 2026, UDI compliance is required for Class IV and III devices and IVDs before being placed on the market.

• Submit your dossier in Portuguese to ANVISA. Your BRH submits all necessary information and documentation required for your product through ANVISA's Solicita digital platform and pays the necessary fees. All documentation must be in Brazilian Portuguese, English, or Spanish, except for labeling and Instructions for Use (IFU), which must be in Portuguese.

• Decision. Once fees are paid, ANVISA will begin its review. Once approved, ANVISA issues a sanitary registration number, which must be added to the device labeling. For foreign manufacturers, the sanitary registration will be issued in the name of your BRH.

To maintain compliance in Brazil, manufacturers and registration holders must comply with post-market surveillance and vigilance requirements. However, this article will focus on pre-market registration activities.

ANVISA medical device and IVD classification

Medical device classification rules in Brazil are based on factors such as the product's intended purpose, invasiveness, and duration of use. RDC 751/2022 contains 22 classification rules for medical devices while RDC 830/2023 contains classification rules for IVDs. If you notified or registered a product (particularly an IVD) before these resolutions came into force, an updated classification assessment can be beneficial, as some Class II products moved to Class III under the modified rules.

ANVISA medical device classification tiers

Medical devices are classified into four tiers of increasing risk:

• Class I (Low Risk): Devices presenting minimal risk, typically non-invasive or with limited patient contact (e.g., bandages and wound dressings).

• Class II (Medium Risk): Devices with a moderate risk profile, which may include some invasive or active products.

• Class III (High Risk): Devices that present higher risk due to greater invasiveness or active function (e.g., certain implantable or long-term use devices).

• Class IV (Maximum Risk): Devices posing the highest level of risk, typically life-supporting or life-sustaining products.

ANVISA IVD classification tiers

IVDs are classified into four tiers according to risk to the individual and/or public health:

• Class I (Low Risk): Products with low risk to the individual and low risk to public health (e.g., general laboratory equipment and basic sample collection tools).

• Class II (Medium Risk): Devices with medium risk to the individual and/or low risk to public health (e.g., certain blood glucose monitoring systems).

• Class III (High Risk): Products presenting high risk to the individual and/or medium risk to public health (e.g., assays used in clinical decision-making for serious conditions).

• Class IV (Maximum Risk): Devices with high risk to both the individual and public health (e.g., assays for detecting HIV or bloodborne pathogens).

ANVISA medical device and IVD pre-registration requirements

Before submitting an application to ANVISA, a few key pieces need to be in place. Foreign manufacturers need to find a BRH and finalize the formal agreement. Depending on your device's classification or functionality, you might also need specific certifications before submitting to ANVISA.

Appoint a Brazil Registration Holder (BRH)

As discussed, all manufacturers not based in Brazil need in-country representation, a rule usually fulfilled by a Brazil Registration Holder. Your BRH must be a legal entity registered in Brazil and hold the requisite sanitary and operating licenses to import and distribute medical devices.

Main responsibilities of the BRH include:

• Dossier submission and management: The BRH submits your product notification or registration to ANVISA and must keep your technical file, legal documents, labels, and IFUs up-to-date and accessible for ANVISA inspections.

• B-GMP compliance: They renew your B-GMP certification with ANVISA every two to four years to maintain validity.

• Managing post-market surveillance: The BRH is responsible for monitoring adverse events; planning and executing field corrective actions or safety alerts; reporting malfunctions or serious health threats to the National Health Surveillance System (SNVS) on time; and coordinating recalls.

• Regulatory liaising: They handle all official ANVISA communication, processing registration renewals, and submitting post-market updates.

• Import authorization: The BRH acquires the necessary authorizations for device importation through customs.

Many distributors are licensed to act as BRHs, but contracting a separate BRH gives you more flexibility and control over your device's distribution long term. The BRH is also legally responsible for your device and for maintaining compliance with all post-market obligations, so it is essential to choose an experienced representative with deep regulatory expertise.

Obtain acceptable QMS evidence in Brazil (B-GMP)

Proof of GMP compliance is required before you can submit your ANVISA registration for Class III and IV devices (Class I and II devices are exempt). You must pass an on-site inspection by ANVISA and renew your B-GMP certification every two years. Renewals must be initiated 270–180 days before expiration, regardless of the pathway. B-GMP certification and renewals carry a fee of $14,560 (BRL 72.804,90) per manufacturer, so be sure to account for this ongoing expense.

Wait times for B-GMP inspections are a major source of delay for ANVISA registrations. If you are anxious to get your product on the Brazilian market, there are ways to expedite the B-GMP timeline:

• Medical Device Single Audit Program (MDSAP). ANVISA accepts MDSAP certificates as a full member of the program. The MDSAP is an international initiative that allows device manufacturers to comply with QMS requirements in multiple participating markets with a single audit from a designated Auditing Organization (AO). If you plan to leverage MDSAP certification in Brazil, your MDSAP certification audit must include Brazil's specific requirements in its scope. MDSAP certification does not fully bypass the B-GMP process; you will still receive a B-GMP certificate from ANVISA. You must also still pay ANVISA's B-GMP initial certification and recertification fees, in addition to your MDSAP audit fees. However, ANVISA may not perform an onsite inspection, which can drastically expedite the B-GMP certification timeline, and you will renew with ANVISA every four years instead of two.

• ABIMED. The Brazilian Association of the Health Technology Industry (ABIMED) has secured a pathway that expedites the B-GMP certification process by allowing manufacturers to proceed with their ANVISA Registration application before B-GMP certification is complete. To qualify, your BRH must be a member of ABIMED, and you must hold a foreign QMS certificate, such as ISO 13485, FDA QMSR, etc.

INMETRO, ANATEL, and INCQS certifications

INMETRO, ANATEL, and INCQS certifications are additional safety and efficacy testing requirements for certain devices regardless of device classification, depending on the product's technical specifications or intended use. These certifications must be obtained before you submit to ANVISA, so you can include the certificates in your dossier.

INMETRO (National Institute of Metrology, Standardization and Industrial Quality) certification applies to devices with electrical components, such as electromedical equipment, specifically devices subject to IEC 60601. INMETRO testing is also required for device types containing certain materials, including hypodermic needles, breast implants, surgical gloves, gloves for non-surgical procedures, and condoms. This process usually involves document reviews, sample testing, and potential manufacturing site audits. The certification framework under INMETRO is also referred to as the Brazilian Conformity Assessment System (SBAC). The INMETRO seal must be displayed on the device labeling.

ANATEL (National Telecommunications Agency) certification is required for any device with Wi-Fi, Bluetooth, or other wireless capabilities. This involves local testing in Brazil, then a Certificate of Conformity (CoC) is issued by a Designated Certification Body (OCD) before ANATEL issues its formal certificate. The certificate ID must appear on the device labeling.

INCQS (National Institute for Quality Control in Health) evaluation applies to certain IVDs, specifically those that diagnose Dengue, Chikungunya, and SARS-CoV-2 (self-test), as well as IVDs intended for blood bank screening, including reagents for immunohematology (ABO system, Rh system, and irregular antibodies), Hepatitis B and C, Syphilis, HIV, Chagas disease, and HTLV.

Prepare to comply with Brazil UDI requirements

ANVISA now requires all manufacturers to assign and register UDI information for all medical devices under RDC 591/2021. This rollout includes UDI labeling requirements consistent with IMDRF guidelines and entering UDI data into ANVISA's UDI system, known as SIUD (Sistema de Identificação Única de Dispositivos Médicos). Manufacturers will need:

• Validated UDI-DI (model level) and UDI-PI (unit level) carriers

• Compliant device and package labeling

• Documented procedures for entering and maintaining data in SIUD.

UDI compliance (UDI appearing on the product label and package) is required for Class III and IV devices before being placed on the market. Class I and II compliance deadlines are as follows:

• Class II: January 10, 2027

• Class I: January 10, 2028

Enforcement applies two years after the respective class deadlines for reusable devices that require direct marking on the device itself.

The deadlines for submitting and transmitting UDI data to SIUD are:

• Class IV: September 1, 2029

• Class III: March 1, 2030

• Class II: March 1, 2031

• Class I: March 1, 2032

Read our blog post on ANVISA's UDI rollout for an in-depth explanation of the requirements.

Required documentation for ANVISA applications

Core documents required for ANVISA Notifications (Classes I and II):

• Notification Form: collects basic technical information about your device (classification, intended use, product and model names, drawings and diagrams, materials lists, etc.) and manufacturer information.

• Manufacturer Authorization Letter (for imported devices): formal statement that authorizes the BRH to represent the foreign manufacturer. Evidence that the BRH holds the proper licenses may also be required.

• SBAC (INMETRO), ANATEL, or INCQS certification, if applicable

• Labeling and IFU samples in Brazilian Portuguese

• Proof of payment of ANVISA fees

Notifications do not require a submitted technical file, but the BRH should have one on hand in case ANVISA requests it.

Core documents required for ANVISA Registrations (Classes III and IV):

• Registration Form: collects basic technical information about your device (classification, intended use, product and model names, drawings and diagrams, materials lists, etc.) and manufacturer information.

• Technical file to ANVISA requirements (in Portuguese)

• Manufacturer Authorization Letter (for imported devices): formal statement that authorizes the BRH to represent the foreign manufacturer. Evidence that the BRH holds the proper licenses may also be required.

• Certificate of Free Sale (for imported devices)

• Good Manufacturing Practices (B-GMP) certificate

• SBAC (INMETRO), ANATEL, or INCQS certification, if applicable

• Labeling and IFU samples in Portuguese

• Proof of payment of ANVISA fees

Additional documents for AREE reliance review:

• Reliance petition form

• Evidence of AREE authorization in Australia, the US, Japan, or Canada

• Instructions for Use (IFU) as authorized by the AREE

Notifications and registrations are submitted to ANVISA electronically via the Solicita portal. Fees must be paid before ANVISA begins their initial review.

Review timelines for ANVISA submissions

Review time for Notifications is often less than 30 days. For Registrations, ANVISA review can take much longer, usually 4–12 months, depending on the risk class and complexity of the device. Registration review timelines are often 30% faster for Class III and IV applications leveraging AREE authorizations.

ANVISA requests for information can further delay the review time. Make sure to respond with all requested information within ANVISA's designated timeline to keep your submission on schedule. As a foreign manufacturer, all information requests will be routed through your BRH, so it is important to work with a professional, responsive BRH with experience managing the full submission timeline.

Faster ANVISA submissions, experienced in-country support

Whether you have a large global portfolio or you are expanding for the first time, specific local requirements in Brazil require early preparation and planning. A qualified Brazil Registration Holder makes all the difference. Pure Global can act as your Legal Representative in Brazil and develop a thorough regulatory roadmap for your product. We build ANVISA submissions in less time with our AI workflows, then validate each submission for completeness and readiness with expert reviews by our experienced regulatory team. Learn more about medical device and IVD registration in Brazil.