Brazil, the largest economy in Latin America, has a well-established and complex regulatory framework for medical devices. As the country’s healthcare sector continues to grow, the regulations play a pivotal role in ensuring that medical devices are safe, effective, and compliant with Brazilian standards before they enter the market. This blog explores the key aspects of medical device regulation in Brazil, providing an overview of the agencies involved, specific requirements for registration, and the processes that manufacturers must navigate to bring their products to market.
Agencies Regulating Medical Devices in Brazil
The Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), is the central authority responsible for regulating medical devices in Brazil. Established in 1999, ANVISA oversees the registration, inspection, and monitoring of medical devices, pharmaceuticals, food, cosmetics, and other health-related products. However, depending on the type of medical device, other agencies may also be involved:
INMETRO (National Institute of Metrology, Quality, and Technology): Responsible for the certification of medical devices that fall under specific categories, particularly those related to electromedical equipment and diagnostics.
ANATEL (National Telecommunications Agency): Regulates medical devices that use radiofrequency, such as wireless medical devices and telemedicine equipment.
ANVISA Acts and Rules for Regulation of Medical Devices in Brazil
ANVISA regulates medical devices through a series of acts, resolutions, and normative instructions. The key legislative acts include:
Resolution RDC 751/2022: This more recent resolution supersedes RDC 185/2001 in many aspects and provides an updated framework for the classification and registration of medical devices in Brazil. RDC 751/2022 aligns Brazilian regulations with international standards and introduces a new risk-based classification system for medical devices. It also outlines the requirements for conformity assessment, technical documentation, and post-market surveillance, ensuring a more streamlined and transparent process.
Resolution RDC 687/2022: Outlines the requirements for Good Manufacturing Practices (GMP) certification for medical devices.
Resolution RDC 830/2023: This resolution, which came into effect from 01 June 2024, specifically addresses the regulation of in vitro diagnostic devices, outlining the requirements for their classification, registration, and performance standards.
Resolution RDC 837/2023: This resolution came into effect from 4th January 2024 and standardizes the requirements for the submission of clinical trial applications for medical devices. It ensures that clinical trials conducted in Brazil meet ethical standards and generate reliable data to support the safety and efficacy of the devices under investigation.
ANVISA Local Representative Requirements for Medical Devices in Brazil
Foreign manufacturers wishing to market medical devices in Brazil must appoint a local representative, known as a Brazilian Registration Holder (BRH). The BRH is responsible for:
Submitting the registration dossier to ANVISA.
Liaising with ANVISA on behalf of the manufacturer.
Ensuring post-market surveillance and compliance with local regulations.
Acting as the legal representative in case of adverse events or recalls.
The BRH must be a Brazilian legal entity with the appropriate technical expertise and infrastructure to manage the responsibilities associated with medical device registration and maintenance.
ANVISA Medical Device Classification in Brazil
Medical devices in Brazil are classified into four risk categories based on their intended use, complexity, and potential risks to patients:
Class I (Low Risk): Devices with minimal risk, such as thermometers, surgical gloves and bandages.
Class II (Medium Risk): Devices with moderate risk, including infusion pumps and dental instruments.
Class III (High Risk): Devices with higher risk, like ventilators and dialysis machines, diagnostic imaging equipment.
Class IV (Very High Risk): Devices with the highest risk, such as pacemakers and implantable defibrillators.