Brazil ANVISA Regulatory Requirements for Medical Devices and IVDs

Brazil’s Registration Process

Medical device authorities in Brazil have made strides to streamline the medical device and IVD registration process, as well as harmonize regulatory requirements with other major markets like the US and Europe. New regulations for medical devices, IVDs, and quality system requirements were introduced in 2022 and 2023 to make the market more accessible, particularly for foreign manufacturers. Here’s a high-level look at the medical device and IVD regulatory framework in Brazil.

Regulatory authority

Medical devices sold or distributed in Brazil are regulated by Agencia Nacional de Vigilância Sanitaria (ANVISA). Market authorization from ANVISA is required before devices or IVDs can be imported to Brazil. ANVISA enforces compliance with Resolution (RDC) 751/2022 for medical devices and Resolution (RDC) 830/2023 for IVDs.

Device classification

According to Resolution (RDC) 751/2022, medical devices are classified as I, II, III, or IV based on their risk profile. Class I devices are the lowest risk and Class IV are the highest. According to Resolution (RDC) 830/2023, IVDs are similarly classified into four tiers according to their risk to users/patients and public health: Class I, II, III, and IV.

Registration process

The regulatory pathway for your device or IVD is determined by its classification. Class I and Class II devices are automatically approved for sale by ANVISA under the Notification pathway. This is a simplified process with less documentation and a shorter, streamlined review. Class III and Class IV devices are subject to the Registration pathway, in which applications undergo a thorough regulatory review before they are approved by ANVISA. Submission requirements include a full technical dossier, QMS certification, device-specific technical or safety certifications (such as INMETRO), labeling, and Instructions for Use.

Quality management system (QMS) requirements

Manufacturers must comply with Brazilian Good Manufacturing Practices (BGMP). Class III and IV devices must pass a QMS audit and obtain BGMP certification according to Resolution (RDC) 665/2022; Class I and II devices are exempt from the audit and certification processes. ANVISA also accepts Medical Device Single Audit Program (MDSAP) certificates that include Brazil requirements in their audit scope.

In-country representation

Foreign manufacturers seeking market authorization in Brazil must appoint a licensed in-country representative called a Brazil Registration Holder (BRH). A BRH is required to submit all regulatory documentation to ANVISA and is the legal owner of your device registration. An entity or individual can act as your BRH as long as they maintain the necessary licenses and are located in Brazil.

ANVISA Registration and Market Entry Support in Brazil

Considering ANVISA registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in Brazil. Contact us to learn more about Brazil registration.