FIME (Florida International Medical Expo)  is the largest medical device trade show in the Americas, and its importance in the healthcare sector is undeniable. Since its inception, FIME has been a crucial meeting point for healthcare professionals, manufacturers, distributors, and regulators from around the world.  FIME was created with the goal of bringing together the main players in the medical device sector in one place, facilitating the exchange of knowledge, the formation of partnerships, and the presentation of technological innovations. Over the years, the trade show has solidified itself as an essential event for those seeking to be at the forefront of trends and innovations in the medical device market.  This year, FIME will take place from June 19 to 21 in Miami, USA. The 2024 edition promises to be even more impactful, bringing together thousands of exhibitors and visitors from various parts of the world. The trade show offers a unique platform to explore the latest innovations in medical technology, from diagnostic devices to advanced treatment equipment.  At FIME 2024, participants will have the opportunity to:  FIME is a global showcase for the latest innovations in medical technology and an essential meeting point for industry professionals. Do not miss the opportunity to participate in this transformative event and stay abreast of the developments shaping the future of healthcare.  If you wish to introduce your products in Brazil through a strong, competitive, and highly reliable structure, schedule a conversation with our CEO, Marcelo Brisolla, and explore the strategies Brisa Advisors can offer to expand your business in the region.  During FIME, our team will be available to discuss how we can support your company in entering this market, from selecting the best sales channels, obtaining regulatory approvals, to effective commercialization. Schedule a meeting at the trade show and discover how we can collaborate to accelerate the entry of your medical devices into the Brazilian market.  We look forward to seeing you at FIME 2024!  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 

The Board of Directors Resolution (RDC) 591/2021, issued by the National Health Surveillance Agency (Anvisa), establishes new guidelines for the identification of medical devices in Brazil through the Unique Device Identification (UDI) system. This resolution marks a significant advancement in the traceability of Class IV risk medical devices. Source: gov.com 2. What does RDC 591/2021 establish? RDC 591/2021 establishes that by July 2024, Class IV risk medical devices must include the UDI on their packaging. Additionally, the resolution defines specific actions to be carried out by companies, such as assigning the UDI, applying the UDI carrier, transmitting information to the UDI database, and including the UDI code in notifications of adverse events, technical complaints, and field actions. 3. What do manufacturers need to do now? It is crucial that manufacturers are aware of the requirements of RDC 591/2021 and act proactively to ensure compliance with the established deadlines. By July 2024, companies must assign and apply the UDI to their Class IV risk medical devices, thereby ensuring precise identification and adequate traceability. Source: gov.com 4. Still have questions on how to proceed? Our experts are available to provide guidance and support throughout the UDI implementation process. Contact us for more information and to ensure compliance with current regulations. 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 

Important Update! In March 2024, the National Health Surveillance Agency (ANVISA) announced a crucial update: the list of technical standards for the certification of compliance of equipment under Health Surveillance has been revised. This measure is essential to keep pace with technological advancements and regulatory changes, ensuring that products marketed in the Brazilian market meet the latest safety and quality standards.  This update represents a significant milestone for the healthcare equipment industry and for all professionals involved in the regulation and oversight of Health Surveillance. It demonstrates Anvisa’s ongoing commitment to promoting the safety and efficacy of products available to Brazilian consumers.  📝 To understand all the changes and their implications, you can access the full text of Regulatory Instruction RDC 283/24:  It is crucial that companies and professionals in the sector are aware of these updates and adapt to the new requirements. Compliance with technical standards is essential to ensure the approval of registration, notification, revalidation, or equipment change requests.  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 

Resolution of the Collegiate Board (RDC) No. 39/2013, amended by RDC No. 15/2014, establishes that the granting of certification for Good Manufacturing Practices of health products (CBPF) may occur upon presentation of a valid audit report, issued by a third-party auditing organization recognized by Anvisa. ANVISA certifications via CBPF are valid for 2 years.  In contrast, the Medical Device Single Audit Program (MDSAP) was created to simplify and ensure rigorous standards of quality and compliance. Recognized by Collegiate Board Resolution (RE) No. 2,347/2015, MDSAP establishes important criteria and promotes efficiency in the auditing process. Certifications obtained through MDSAP are valid for 4 years.  Therefore, it is essential for companies to be aware of the available options and the validity periods associated with each type of certification, thus ensuring regulatory compliance and the quality of health products.  Check below the list of Auditing Organizations approved by the MDSAP Program and recognized by ANVISA along with their relevant information:   Audit Organization Resolution Resolution Link Validity of Recognition TUV Rheinland of North America, Inc. RE 2.851/2022 Link 15/08/2026 DQS Medizinprodukte GmbH RE 2.136/2023 Link 16/06/2026 GMED RE 1.7725/2023 Link 22/05/2026 SGS United Kigdom Ltd. RE 2665/2022 Link 07/04/2026 BSI Group America Inc RE 1.558/2021 Link 28/02/2025 Intertek Testing Services NA Inc. RE 1.181/2021 Link 23/02/2025 UL Medical and Regulatory Services of UL LLC RE 3448/2021 Link 25/08/2025 NCC Certificações do Brasil Ltda. RE 2909/2023 Link 25/07/2024 MedCert RE 1.329/2021 Link 19/03/2023 DEKRA Certification B.V. RE 1.054/2019 Link 06/02/2022 National Standards Authority of Ireland (NSAI) RE 1.754/2019 Link 05/09/2022 TUV USA, Inc. RE 2.654/2018 Link 04/09/2022 TUV SUD America Inc. RE 324/2017 Link 31/12/2020 It is crucial for companies to be aware of these Auditing Organizations recognized by ANVISA and to comply with the standards established by MDSAP. Ensuring the quality and safety of health products is a priority, and relying on recognized auditors is an essential step in this process.  Looking for guidance on how to comply with the requirements of RDC 850/2024? 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 

In yesterday’s post we talked about the publication of IN 290/2024, which talks about the procedure for optimized analysis of petitions for registration of Medical Devices through the use of analyzes carried out by an Equivalent Foreign Regulatory Authority. Today we bring the highlights of this regulation for clarification: ANVISA determined some rules for this optimized procedure, which are: 1- The following Regulatory Agencies and respective proof of registration or authorization will be accepted for the purposes of adopting the optimized analysis procedure:– Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of Therapeutic Goods (ARTG);– Canada: Health Canada (HC) – Medical Device License;– United States of America (USA): US Food and Drug Administration (US FDA) – 510(k) Clearance, Premarket Approval (PMA) or 513(f)(2) “De Novo”;– Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Pre-market approval (Shonin). 2- The petition must be posted in the same way as before, containing all documents. 3- The supporting documentation for the optimized analysis must be requested as an amendment, that is, a second petition. After verifying this second petition, ANVISA will define whether the optimized analysis will be accepted or whether the ordinary analysis will be followed. The registration proof document must make reference to the essentially identical medical device intended to be registered in Brazil and include information relating to the indication(s) of use/intended use and manufacturer(s), 4- The IFU/user manual of the medical device to be presented in Brazil must be the same as that adopted and in force in the registered country 5- This optimized analysis does not speed up the analysis queue. The process will follow the normal queue time. It is a great advance to have the possibility of simplifying the analysis process. The hope is that the petition queue will move 30% faster. Click here to access the translated Normative Instruction #regulatoryaffairs#medicaldevices#imdrf#anvisa#fda#TGA#healthcanada#shonin

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