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January 15, 2026
Approximately 5 minutes
Resolution of the Collegiate Board of Directors (RDC) No. 751/2022, effective March 1, 2023, provides the core regulatory framework for medical devices in Brazil, covering risk classification, labeling, instructions for use, notification, marketing authorization (registration), alterations, revalidation, and cancellation. It applies to devices requiring notification or authorization based on risk class, including accessories. Exclusions include IVDs (separate regulation), used/reconditioned devices, custom-made devices, and certain combined products. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Devices are classified into four risk classes:
Classification is based on intended purpose and 22 rules in Annex I, considering duration of use (transient <60 min, short-term 60 min-30 days, long-term >30 days). The most stringent applicable rule prevails. Software as a medical device (SaMD) is classified independently if standalone. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Key rules include:
In case of doubt, ANVISA determines the class. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Required elements include fees, forms, manufacturer authorization (for imports), GMP certificate (III/IV), SBAC conformity (electromedical), and compliance declarations. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Alterations are categorized as:
Revalidation required for III/IV every 10 years with updated GMP. Cancellation possible for non-compliance, false information, or safety risks. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Must be in Portuguese, include ANVISA registration number, manufacturer/holder details, traceability (batch/serial), warnings, and symbols per standards. Instructions for use mandatory except for low-risk devices where safe without. Electronic instructions allowed under conditions. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Maintained by the holder (not submitted routinely but available for inspection). Structured per Annex II, with increasing detail by class: description, safety/performance studies, manufacturing, labeling, etc. Critical for III/IV authorization. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Devices under old framework remain valid until alterations or revalidation. 365-day period post-March 2023 for reclassification shifts (e.g., notification to authorization requires full submission and GMP). Revokes prior resolutions. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
Accurate classification is foundational—document intended purpose rigorously. Prepare for GMP and SBAC where applicable. Track alterations to avoid suspensions. Transitional reclassifications require urgent action to prevent cancellation. Source: ANVISA RDC No. 751/2022 (English translation) (https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/2024/rdc-751-2022-en.pdf)
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ElendiLabs
If the wearable device does not make medical claims and is marketed strictly as a wellness or lifestyle product, it may fall outside the scope of medical device regulation in Brazil. However, if the product claims to monitor or diagnose medical conditions, ANVISA may classify it as a medical device and require registration or notification. Companies should carefully review labeling and intended use statements.
Anonymous
We are exporting diagnostic reagents to Brazil through a distributor. Are distributors responsible for regulatory compliance or does the manufacturer handle everything with ANVISA?
ElendiLabs
In Brazil, the Brazilian Registration Holder (often the local distributor or regulatory partner) plays a central regulatory role. The BRH submits the registration to ANVISA and manages communications with the authority. However, the manufacturer remains responsible for providing technical documentation, quality system evidence, and supporting post-market surveillance activities.
Anonymous
我们公司正在开发一款AI辅助诊断软件，计划在巴西上市。根据近期巴西监管讨论，这类软件是否会被当作医疗器械进行监管？
ElendiLabs
在巴西，如果软件具有诊断、监测或治疗相关的医疗用途，通常会被视为医疗器械（Software as a Medical Device）。ANVISA近年来对数字健康技术和AI医疗软件的监管讨论越来越多，因此企业在上市前应确认软件的风险分类，并准备技术文件和性能验证资料。
Anonymous
如果企业已经在欧盟获得CE认证，在巴西注册医疗器械时是否可以简化审批流程？
ElendiLabs
虽然CE认证不能直接替代巴西ANVISA的注册要求，但已有的国际认证（如CE或ISO 13485）通常可以作为技术文件的一部分提交，并有助于证明产品的安全性和质量体系。企业仍然需要按照巴西法规准备注册或备案资料。
Anonymous
Hello, we manufacture orthopedic implants in Germany and are planning to enter the Brazilian market. Based on the recent regulatory topics highlighted in Brazil, should we expect additional post-market surveillance obligations when registering with ANVISA?
ElendiLabs
Yes. Recent regulatory discussions in Brazil emphasize stronger post-market surveillance and vigilance requirements. When registering medical devices with ANVISA, manufacturers and their Brazilian Registration Holders (BRH) must maintain procedures for complaint handling, adverse event reporting, and traceability. These obligations are increasingly emphasized in regulatory updates, so companies entering Brazil should prepare robust post-market monitoring systems.
Anonymous
請問如果我們是一家香港公司，想把牙科掃描設備出口到巴西，是否一定需要當地的Brazilian Registration Holder（BRH）？
ElendiLabs
是的，在巴西註冊醫療器械通常需要一個本地的 Brazilian Registration Holder（BRH）。BRH 負責與 ANVISA 溝通、提交註冊申請、以及履行上市後監管義務。對於海外製造商來說，選擇合適且有經驗的 BRH 是進入巴西市場的重要一步。
Approximately 5 minutes
In Brazil, ANVISA regulates medical devices with risk-based classification (Classes I-IV), notification for lower-risk devices, full registration for higher-risk, mandatory GMP for Classes III/IV, and specific rules for imports, IVDs, SaMD, and used devices.
Approximately 5 minutes
RDC 830/2023 establishes Brazil's risk-based regulation for IVDs, defining Classes A-D with 8 classification rules, notification for lower-risk (A/B), full registration for higher-risk (C/D), mandatory performance evaluation for C/D, specific labeling, and transitional provisions effective October 2023.
Approximately 5 minutes
RDC 657/2022 establishes specific requirements for SaMD in Brazil, including definitions, scope/exclusions, classification alignment with general rules, regularization pathways, enhanced labeling/cybersecurity, detailed technical dossier, in-house exemptions, and post-market obligations, effective July 2022.
Approximately 5 minutes
RDC 591/2021 implements Brazil's UDI system aligned with IMDRF, requiring manufacturers to assign UDI (DI + PI) using accredited issuers, apply AIDC/HRI on labels/packaging, submit data to ANVISA database, with phased timelines by risk class starting 2022.
Approximately 5 minutes
RDC 848/2024 updates Brazil's essential safety and performance requirements for medical devices and IVDs, emphasizing risk management throughout lifecycle, clinical evaluation, cybersecurity for software, radiation protection, and alignment with state-of-the-art, effective September 2024.
Approximately 5 minutes
RDC 925/2024 establishes specific requirements in Brazil for custom-made and patient-matched medical devices, including justification documentation, manufacturer declaration, post-market surveillance, high-risk device restrictions, and transitional provisions effective from 2024.
Anonymous
Our startup produces wearable health monitoring devices. We heard Brazil has been discussing updates to regulatory priorities. Would consumer wellness devices without medical claims still require ANVISA registration?