ElendiLabs
製造商須維持技術檔案並進行上市後監測。RDC 848/2024強調整個生命週期風險管理與臨床評估更新。客製化器械（RDC 925/2024）及SaMD亦有特定上市後要求，包括警戒與追蹤。
Want real case studies? 10 seconds to sign up
Join the platform
Back to Articles
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
Registration
January 20, 2026
Approximately 5 minutes
Brazil ANVISA RDC 848/2024: Essential Safety and Performance Requirements for Medical Devices and IVDs
1. Overview and Scope
Collegiate Board Resolution - RDC No. 848, dated March 6, 2024 (published March 8, 2024), establishes the essential principles of safety and performance applicable to all medical devices and in vitro diagnostic (IVD) medical devices in Brazil. It replaces RDC No. 546/2021 and came into force 180 days after publication (September 2024). The resolution aims to ensure devices are designed and manufactured to achieve intended performance while maintaining an acceptable risk-benefit ratio, considering the state of the art. Some principles may not apply to specific devices, with justifications required. Compliance is verified through technical dossiers, GMP inspections, and regularization processes. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
2. General Safety and Performance Requirements
Devices must:
- Achieve manufacturer-intended performance and be suitable for the declared purpose under normal conditions.
- Be safe, with risks acceptable compared to patient benefits, not compromising health/safety of patients, users, or others.
- Maintain characteristics/performance during shelf life, transport, storage, and use.
Risks must be reduced as far as possible without adversely affecting the benefit-risk ratio, considering state-of-the-art technology. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
3. Risk Management Throughout Lifecycle
Manufacturers must establish, implement, document, and maintain a systematic risk management system covering the entire lifecycle, including:
- Risk management plan.
- Hazard identification, risk estimation/evaluation (including foreseeable misuse).
- Risk control measures (prioritize safe design, protective measures, then user information).
- Post-production information review and system updates.
Residual risks must be disclosed where relevant. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
4. Clinical Evaluation and Data
Clinical data must support safety, performance, and benefit-risk via ongoing clinical evaluation:
- Literature analysis or clinical investigations (per good clinical practices if needed).
- Updated throughout lifecycle.
- Mandatory investigations where literature insufficient for high-risk or novel devices.
Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
5. Chemical, Physical, and Biological Properties
Devices must be biocompatible, non-toxic, and minimize risks from substances, contaminants, leaching, particles (including nanomaterials), and infection transmission. Animal-derived materials require controlled sources and inactivation processes. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
6. Infection and Microbial Contamination
Sterile devices must use validated sterilization methods with suitable packaging. Reprocessable devices must allow effective cleaning/sterilization. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
7. Devices with Software and Cybersecurity
Software-incorporating devices (including SaMD) must ensure accuracy, reliability, and cybersecurity throughout lifecycle, with validated development processes and specified IT requirements. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
8. Active Devices and Energy Delivery
Reduce risks from electrical/mechanical/thermal hazards, electromagnetic interference, and single-fault conditions. Provide alarms/indicators for critical parameters. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
9. Radiation Protection
Minimize exposure while achieving diagnostic/therapeutic purpose. Provide dose information, controls, and warnings. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
10. Devices for Lay Use and Specific Categories
Lay-user devices must minimize error risks and provide clear instructions/verification means. Additional rules for implants, substance-administering devices, and those incorporating medicines. For IVDs: analytical and clinical performance, traceability, and population-specific evaluation. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
11. Labeling and Instructions for Use
Information must be clear, understandable, and include identification, warnings, performance data, and residual risks. Electronic instructions allowed under conditions. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
12. Conformity Assessment and Documentation
Demonstrated via technical dossier maintained by manufacturer, verified during regularization (notification/registration) and inspections. Aligns with broader framework (e.g., RDC 751/2022 for classification, RDC 549/2021 for electromedical SBAC certification). Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
13. Transitional Provisions
Protocols submitted before effectiveness may use prior requirements (RDC 546/2021). Full application mandatory for new submissions post-September 2024. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
14. Practical Considerations for RA Managers
Update technical dossiers to address new emphases (cybersecurity, lifecycle risk management, clinical data). Justify non-applicable principles. Coordinate with certification bodies for electromedical (SBAC/INMETRO). Review legacy devices for compliance gaps during revalidation. Source: ANVISA RDC No. 848/2024 (English translation) (https://brisa.com.br/wp-content/uploads/2024/03/RESOLUTION-RDC-No.-848-OF-MARCH-6-2024.pdf)
ElendiLabs Regulatory Affairs Team
Verified RA Consultants
100+ products successfully registered across global markets. Get unbeatable quotations and expert answers — fast.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
Questions & Answers (6)
A
Anonymous
Guest
What are the mandatory UDI requirements for any class of medical device or IVD when placing products on the Brazilian market?
ElendiLabs
All devices must comply with the UDI system per RDC 591/2021: UDI = Device Identifier (DI) + Production Identifier (PI), issued by accredited agencies, applied via AIDC or HRI on labels/packaging. Data must be submitted to the ANVISA database with phased implementation timelines by risk class (starting 2022). This supports traceability and post-market surveillance.
陳
陳曉
Guest
在巴西註冊高風險Class IV植入式醫療器械時，臨床數據的要求有哪些？
ElendiLabs
臨床數據必須支援安全、效能及效益-風險分析，透過持續臨床評估（包括文獻分析或臨床調查）。高風險或新型器械通常需進行臨床調查（符合良好臨床規範）。RDC 848/2024要求整個生命週期更新臨床評估資料。
ER
Emily Rodriguez
Guest
As a US manufacturer planning to register Class II dental implants (medium-risk) in Brazil, what risk classification rules apply and which registration pathway is required under ANVISA?
ElendiLabs
Medical devices in Brazil follow a risk-based classification with four classes (I-IV) under RDC 751/2022 using 22 classification rules. Class II dental implants require the full registration pathway (not simple notification), including submission of a technical dossier, compliance with essential safety and performance requirements in RDC 848/2024, GMP certification (mandatory for higher classes), and UDI implementation per RDC 591/2021.
SP
Sarah Patel
Guest
For Software as a Medical Device (SaMD) intended for the Brazilian market, what specific regulatory obligations exist beyond general device rules?
ElendiLabs
SaMD follows RDC 657/2022: aligned classification with risk-based rules, dedicated regularization pathways, enhanced labeling and cybersecurity requirements, detailed technical dossier, and post-market obligations. In-house use exemptions may apply in certain cases.
李
李小姐
Guest
作為中國製造商，我想將Class C體外診斷試劑（IVD）導入巴西市場，ANVISA的分類系統如何決定審批途徑？需要性能評估嗎？
ElendiLabs
IVD在巴西按風險分為A-D類（RDC 830/2023，共8條分類規則）。Class C屬較高風險，需完整註冊途徑（非通知）。必須進行分析性能和臨床性能評估，並符合RDC 848/2024的安全與效能基本原則，包括可追溯性與族群特定評估。
Related Articles
Registration
Approximately 5 minutes
Brazil ANVISA RDC 751/2022: Medical Device Risk Classification Rules and Regulatory Requirements
RDC 751/2022 establishes Brazil's risk-based framework for medical devices, defining four classes (I-IV), 22 classification rules, notification for lower-risk, registration for higher-risk, labeling, technical dossier, and transitional provisions effective March 2023.
Registration
Approximately 5 minutes
Brazil ANVISA RDC 830/2023: In Vitro Diagnostic Device Risk Classification and Regulatory Requirements
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.
Registration
Approximately 5 minutes
Brazil ANVISA RDC 657/2022: Regulatory Framework for Software as a Medical Device (SaMD)
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.
Registration
Approximately 5 minutes
Brazil ANVISA RDC 591/2021: Unique Device Identification (UDI) System for Medical Devices
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.
Registration
Approximately 5 minutes
Medical Device Regulation in Brazil: ANVISA Risk Classification, Registration, and Certification Requirements
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.
Registration
Approximately 5 minutes
Brazil ANVISA RDC 925/2024: Regulatory Requirements for Custom-Made and Patient-Matched Medical Devices
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.
Important Disclaimer
Anonymous
醫療器械或IVD在巴西上市後，製造商必須履行哪些上市後監測義務？