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January 25, 2026
Approximately 5 minutes
Brazil ANVISA RDC 925/2024: Regulatory Requirements for Custom-Made and Patient-Matched Medical Devices
Brazil ANVISA RDC 925/2024: Regulatory Requirements for Custom-Made and Patient-Matched Medical Devices
1. Overview and Scope
RDC No. 925/2024, published in 2024, sets forth specific requirements for the manufacture, import, marketing, and use of custom-made and patient-matched medical devices in Brazil. It complements the general framework (RDC 751/2022) by addressing devices produced to meet specific patient needs when no equivalent regularized device is available. Applies to non-mass-produced devices designed using patient-specific anatomical data (e.g., 3D-printed implants). Excludes mass-produced devices adaptable without custom design and investigational devices. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
2. Definitions
- Custom-made device: Non-mass-produced, designed and manufactured for a specific patient based on medical prescription and anatomical needs.
- Patient-matched device: Produced in series but designed/adapted using patient imaging data within defined limits.
Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
3. Justification and Prescription Requirements
Custom-made devices require written prescription from qualified healthcare professional justifying absence of equivalent regularized alternatives. Manufacturer must provide statement/declaration confirming design meets prescription and patient needs. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
4. Regularization Pathways
Low-risk custom-made devices may be exempt from registration/notification under certain conditions, with manufacturer maintaining documentation. High-risk (Class III/IV, e.g., implantable) require full registration with additional technical justification, risk management, and clinical evidence where applicable. Patient-matched devices generally follow standard pathways unless high-risk. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
5. Manufacturer Obligations
Manufacturers must:
- Implement quality management system compliant with Brazilian GMP (RDC 665/2022 or equivalent).
- Conduct risk management throughout lifecycle.
- Maintain technical documentation including design justification, validation, and post-production monitoring plan.
- Provide declaration of conformity and patient-specific information.
Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
6. Labeling and Traceability
Devices must include manufacturer details, patient identification (where applicable), custom nature statement, and prescription reference. Enhanced traceability for implants. Instructions for use tailored to patient. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
7. Post-Market Surveillance
Mandatory enhanced post-market monitoring, including patient registries for high-risk implants. Adverse events and field actions reported per general rules. Annual summary reports for certain devices. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
8. Import and Marketing Restrictions
Import requires Brazilian Registration Holder. High-risk custom-made devices (e.g., Class III/IV implants) subject to stricter controls and possible prior ANVISA authorization. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
9. Transitional Provisions
Devices regularized before effectiveness maintain validity until expiry or major changes. Adaptation period for compliance with new requirements. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
10. Practical Considerations for RA Managers
Document justification rigorously—absence of alternatives critical. High-risk custom-made (e.g., orthopedic implants) require robust clinical/performance data and PMS plans. Coordinate with prescribers and BRH for compliance. Monitor for updates on registries and reporting. Source: ANVISA RDC No. 925/2024 (https://anvisalegis.datalegis.net/action/UrlPublicasAction.php?acao=abrirAtoPublico&num_ato=00000925&sgl_tipo=RDC&sgl_orgao=RDC/DC/ANVISA/MS&vlr_ano=2024&seq_ato=000&cod_modulo=134&cod_menu=1696)
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