Resolution of the Collegiate Board (RDC) 579/2021, issued by the National Health Surveillance Agency (ANVISA), establishes important norms regarding the importation, commercialization, and donation of used and refurbished medical devices. This regulatory measure responds to the need to ensure the safety and quality of these devices, as well as the protection of patients and healthcare professionals.
Key Aspects of RDC 579/2021:
Clear and Comprehensive Definitions: The resolution provides precise definitions of used and refurbished medical devices, establishing clear criteria for their identification and classification. This provides a solid foundation for the application of regulatory standards and proper oversight of these products.
Importation and Commercialization Requirements: RDC 579/2021 establishes specific requirements for the importation and commercialization of used and refurbished medical devices, including the need for registration with ANVISA and compliance assessments. These measures aim to ensure that only safe and quality devices are made available in the Brazilian market.
Prohibition of Refurbished Single-Use Devices: The resolution expressly prohibits the importation, commercialization, and donation of single-use devices that have been refurbished. This is due to the risks associated with the reuse of these devices, which can compromise their effectiveness and safety.
Labeling Requirements and Consumer Information: RDC 579/2021 establishes detailed requirements for the labeling of used and refurbished medical devices, including information about the device’s condition, usage history, and origin. This ensures that users have access to clear and accurate information about the product they are using.
RDC 579/2021: Used and Refurbished Medical Devices – Impact and Regulatory Implications
Resolution of the Collegiate Board (RDC) 579/2021, issued by the National Health Surveillance Agency (ANVISA), establishes important norms regarding the importation, commercialization, and donation of used and refurbished medical devices. This regulatory measure responds to the need to ensure the safety and quality of these devices, as well as the protection of patients and healthcare professionals.
Key Aspects of RDC 579/2021:
Clear and Comprehensive Definitions: The resolution provides precise definitions of used and refurbished medical devices, establishing clear criteria for their identification and classification. This provides a solid foundation for the application of regulatory standards and proper oversight of these products.
Importation and Commercialization Requirements: RDC 579/2021 establishes specific requirements for the importation and commercialization of used and refurbished medical devices, including the need for registration with ANVISA and compliance assessments. These measures aim to ensure that only safe and quality devices are made available in the Brazilian market.
Prohibition of Refurbished Single-Use Devices: The resolution expressly prohibits the importation, commercialization, and donation of single-use devices that have been refurbished. This is due to the risks associated with the reuse of these devices, which can compromise their effectiveness and safety.
Labeling Requirements and Consumer Information: RDC 579/2021 establishes detailed requirements for the labeling of used and refurbished medical devices, including information about the device’s condition, usage history, and origin. This ensures that users have access to clear and accurate information about the product they are using.
Who Can Import and Commercialize Refurbished Products: According to RDC 579/2021, products subject to refurbishment must be regularized with ANVISA, following the guidelines set forth in RDC 751/2022 and RDC 36/2015 (to be replaced by RDC 830/2023), and the refurbishment factory must be included in the equipment registration. The importing company must have an Operating Authorization (AFE). Initial regularization will not be granted exclusively for refurbished equipment.
Impact and Importance of RDC 579/2021:
RDC 579/2021 plays a crucial role in protecting public health by establishing rigorous standards for the importation, commercialization, and donation of used and refurbished medical devices. By ensuring the safety and quality of these devices, the resolution contributes to preventing harm to patients and ensuring the safety of healthcare professionals.
Additionally, the resolution also promotes transparency and trust in the market by establishing clear and objective requirements for the importation and commercialization of these products. This helps protect consumer interests, ensuring that only safe and quality devices are made available for use.
In summary, RDC 579/2021 represents a significant advancement in the regulation of used and refurbished medical devices, contributing to the protection of public health and the promotion of the well-being of patients and healthcare professionals. Through its rigorous requirements and comprehensive approach, the resolution sets a high standard of safety and quality for these devices, thereby ensuring a reliable and secure regulatory environment.
- Read RDC 848/2024 here: Link to the Resolution
- The translated version in English is available here: RDC – 579/2021
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