Brazil stands as Latin America's largest medical device market, regulated by ANVISA with recent updates to accommodate new technologies and international harmonization.
Brazil is the largest medical device market in Latin America. The Brazilian regulatory registry for medical devices and in-vitro diagnosis is managed by ANVISA (National Health Surveillance Agency). ANVISA is responsible for regulating the registration of medical devices and in-vitro diagnosis products in the country. The registration process can be complex, but with the help of a specialized Pure Global team you can navigate the regulatory maze more easily. Pure Global has an extensive global expertise, and service network, supported by innovative AI technology in regulatory affairs to Brazil market, and can help you understand the entire registration process for your medical device or in-vitro diagnosis product in Brazil.
The RDC (Resolution of the Collegiate Board) 751/2022 published by ANVISA has just become effective on March 1st of 2023. The main purpose of the change in the Brazilian regulation regarding medical devices was to modernize it, making it possible to address new technologies that were not foreseen in the previous RDC 185/2001, such as software as medical devices (SaMD) and nano-materials. In addition, the RDC implements the MERCOSUL Resolution GMC 25/2021, agreed among Argentina, Paraguay, Uruguay and Brazil, and shows an effort of the Brazilian regulatory agency in harmonizing its concepts and required documents internationally, especially with the International Medical Device Regulators Forum (IMDRF), formed by Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea, UK and US. Brazil is part of the Medical Device Single Audit Program (MDSAP) and co-founder of the International Medical Device Regulators Forum (IMDRF).
The regulation applies to all medical devices that fall into its definition provided in the regulation, which is very similar from the one from EU-MDR. Used or reconditioned medical devices, custom-made devices, drugs, cell, tissue, organ or blood from human origin or derivatives, cosmetics, sanitizing or food products for which there is specific regulation apart are out of the scope of the resolution.
In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated the RDC (Resolution of the Collegiate Board) 830/2023 covering In Vitro Diagnostic (IVD) Medical Devices, bringing it closer to the one on Medical Devices RDC (Resolution of the Collegiate Board) RDC 751/2022 and abandoning the previous Regulation, Resolução Da Diretoria Colegiada – RDC Nº 36, de 2015 (RDC 36/2015). The new RDC (Resolution of the Collegiate Board) 830/2023 published by ANVISA has an effective date of June 1, 2024.
ANVISA categorizes medical devices into four types: medical equipment, materials for health use, orthopedic implants, and in vitro diagnostics (IVD). The risk classification of medical devices is based on the potential risks associated with their use. The classification system ranges from Class I (low risk) to Class IV (high risk).
For medical devices, market authorizations are issued by ANVISA depending on the risk classification of the device. Market authorizations for products categorized as Risk Class I and II do not expire, but they might be cancelled upon request, in case of reassessment, in the impossibility of solving irregularities, or when fraud is detected. Pre-market approvals for products categorized as Risk Class III and IV are valid for 10 (ten) years from the date of their publication in the Brazilian Official Gazette and may be renewed for equal and successive periods.
For IVDs, the registration process is like that of medical devices. The risk classification of IVDs is also based on the potential risks associated with their use. The classification system ranges from Class I (low risk) to Class IV (high risk), and market authorizations are identical.
When it comes to registering your medical device or in-vitro diagnosis product in Brazil, partnering with Pure Global can be a positive step. Here are some reasons why:
The regulations RDC 751/2022 and RDC 830/2023 have brought about some changes to the registration process for medical devices and in-vitro diagnosis products in Brazil. Pure Global have professionals with years of experience with wealth of experience in regulatory affairs in Brazil and can help you understand the entire registration process for your medical device or in-vitro diagnosis product in Brazil. With our expertise, local knowledge, and efficiency, we can help you navigate the regulatory landscape more easily and ensure that your medical device or in-vitro diagnosis product is registered smoothly.
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