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.  Looking for guidance on how to comply with the requirements of RDC 579/2021? Contact us today.  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

RDC 850/2024 was published today, which amends RDC 497/2021 in its Article 8 with the inclusion of information that manufacturers adhering to the MDSAP program now have GMP Certification valid for 4 years, as long as they remain members of the program with certification valid for the same period. It is worth noting that RDC 497/2021 provided for a generic validity of two years for any manufacturer, whether or not part of the MDSAP. If your company has MDSAP certification and does not yet do business in Brazil, take the opportunity to sail into a blue ocean of opportunities! Our team of experts is ready to understand your expectations and operate your entry into the Brazilian market with excellence. Schedule a call today! To read the translated version of RDC, click here.

Anvisa has recently announced an update to safety and performance requirements for medical devices, including in vitro diagnostic devices (IVDs), through RDC 848/2024. This measure, approved in the last meeting of the Collegiate Directorate (Dicol) on Wednesday (06/03), brings significant advancements since the replacement of the previous standard, RDC 56/2001.  What’s Changing? With technological advancements over the last 23 years, the new resolution aims to adapt regulations to innovations in the field of medical devices. The updated requirements seek to enhance technical assessment by Anvisa, addressing the challenges posed by new technologies and the diversity of devices.  One of the benefits of this update is enhanced guidance for manufacturers: they will have clear guidelines on the studies and evidence required for product registration, increasing the robustness of the submitted documentation.  Regulatory Harmonization: This move by Anvisa also aligns with efforts towards regulatory harmonization in Mercosur, adopting the Mercosur Technical Regulation based on the guidelines of the International Medical Device Regulators Forum (IMDRF).  In addition to updating essential safety and performance requirements, the new RDC also incorporates the Mercosur Technical Regulation into the national legal framework, repealing Resolution GMC 72/98.  For manufacturers and healthcare professionals, this is a good time to familiarize themselves with the new guidelines and ensure their products and practices are fully compliant.   #RegulatoryAffairs #BrisaAdvisors #BPOinRA#Anvisa #MedicalDevices #Regulation #Health #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Only in public bids mapped by our bid tracking system did we find more than 45 million in sales for this kit in 2023. This value does not include private institutions. Count on our team of experts to file your request for Good Practice Certification and register your products for Dengue detection. Schedule a call with us now! #ivd#medicaldevices#regulatoryaffairs#ANVISA#dengue Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Recently, the National Health Surveillance Agency (Anvisa) issued an informative statement regarding the use of smartwatches for glucose monitoring. This news has sparked discussions about the applicability and safety of these devices in health management, especially for people with diabetes.  In the statement, Anvisa emphasizes that there are currently no registered or authorized medical devices in Brazil for glucose monitoring through smartwatches. This raises significant questions about the reliability and accuracy of the results obtained from these devices.  It is important to note that accurate and reliable glucose monitoring is crucial for proper diabetes control and treatment decision-making. Therefore, the use of unregulated devices may pose a health risk to users.  Anvisa reinforces the need to consult qualified healthcare professionals for proper glucose monitoring and for choosing appropriate and safe devices. Additionally, it highlights the importance of following current guidelines and regulations to ensure safety and effectiveness in healthcare.  In light of this, it is essential for users to be aware of the limitations and necessary precautions when using glucose monitoring technologies, always seeking up-to-date and reliable information.  For further details and information, we recommend reading the full official statement from Anvisa, available on our blog. Check it out!  https://lnkd.in/eaRRciFy  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices  #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br