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 

1 – I have products registered in the name of my distributor or even in the name of acompany that hosts registers. Is it possible to make another registration of these sameproducts, i.e., having the same product registered twice by different companies(registration holders)?BRISA ADVISORS: Yes, it is possible to have the same product registered by more thanone registration holder at ANVISA. But also, it is possible to transfer ownership of classIII and IV products when the current registration holder agrees with this procedure. 2 – In which cases can I request the transfer of ownership of registers?BRISA ADVISORS: In corporate and commercial operations between companies thatcarry out activities subject to sanitary control – ANVISA, which implies the change ofownership of product registration, since the conditions and technical-sanitarycharacteristics of companies, products and clinical trials are kept. 3 – Which are the definitions adopted by RDC No. 102/2016?BRISA ADVISORS:I – technical and health characteristics: regular conditions of the product, company, orclinical trial at ANVISA, immediately before the corporate or commercial operation;II spin-off: corporate operation in which a legal entity transfers parts of its property toone or more legal entities established for this purpose, or already existent, extinguishingthe demerged company if all its assets are transferred, or dividing the capital if thetransfer is partial;III – succeeded company: legal entity that transfers to the successor company the rightsand obligations on the product object of registration transfer, the establishment, or theresponsibility for clinical testing as a result of corporate or commercial operations;IV – successor company: legal entity that now has the rights and obligations on theproduct object of registration transfer, the establishment, or the responsibility forclinical testing as a result of corporate or commercial operations;V – merger: corporate operation in which two or more legal entities are merged to createa third one, succeeding them in all rights and obligations;VI – incorporation: corporate operation in which one or more legal entities are absorbedby another one, succeeding them in all rights and obligations;VII – commercial operation: operation between companies resulting in the sale of assetsor group of assets, without the occurrence of any corporate transaction between thecompanies involved;VIII – corporate transaction: corporate action involving the merger, spin-off orincorporation under Law no. 10,406, of January 10th, 2002, and, in a subsidiary manner,Law no. 6,404, of December 15th, 1976;IX – Mercosur representative: company located in the Receiving State Party [EstadoParte Receptor (EPR) in Portuguese], which is contracted to represent a registrationholder in the Producing State Party [Estado Parte Produtor (EPP) in Portuguese] andassumes the legal and technical responsibility in the EPR;X – global transfer of responsibility for clinical testing: modification characterized by thechange of the applicant of clinical trial dossiers, notification of clinical testing, dossiersof clinical development of drugs (DDCM), dossiers of clinical investigation of medicaldevices (DICD), expanded access programs, compassionate use programs and supply ofpost-study drug, in cases of corporate or commercial operations, without any change oftechnical and health characteristics contained in the Specific Special Communiqué[Comunicado Especial Específico (CEE) in Portuguese], Document for the Import ofProduct under Investigation or Special Communiqué), object of change;XI – transfer of registration holder: modification characterized by the change of theregistration holder of products subject to health surveillance, in case of corporate orcommercial operations, without any change of technical and health characteristics inthe registration of product object of transfer. 4 – In cases of commercial or corporate operations carried out abroad, does this RDCalso apply?BRISA ADVISORS: Only in cases where these operations carried out abroad imply theneed to update data at ANVISA by the registration holder in Brazil, such as updating theCBPF or in case of alteration in the registers of existing products to communicate withthe new manufacturer. 5 – Can the Certificate of Good Manufacturing Practices (CBPF) and the Company’sOperating Permit (AFE) be transferred along with the registration of the product?BRISA ADVISORS: In fact, already published BPF certificates can have their updatedregistration data for the new applicant, provided that the previously examinedtechnical-health characteristics, whenever the corporate or commercial operation ofregistrations of already deferred products. The validity of the certificate does notchange, it will remain the same as the initial order made by the succeeded company.For initial requests of CBPF that are still awaiting or with analysis not yet completed, itwill not be possible to update the registration data. The succeeded company mustpromote the addition of the petition to update the documentation, with a view toinstructing and continuing the analysis of the petition in progress.The AFE may be updated through a petition for amendment, cancellation, or concession,whenever there is a corporate transaction that will result in a new person legal entity,or when there is already a legal entity not regularized with the surveillance health,regularization will always be through an initial grant request for AFE.It is important to point out that the Certificate of Good Manufacturing Practices aregranted for each establishment, by production line. When the succeeded company’soriginal certificate must be maintained, the successor company must request on itsbehalf a new certificate for the line involved. This situation may lead to a new sanitaryinspection.6 – Which are the deadlines that must be watched?BRISA ADVISORS:a) 180 days: For requests for transfer of ownership and cancellation of registration ofhealth products, which must be concurrently filed with ANVISA, respectively by thesuccessor and succeeded company, the period is up to 180 (one hundred and eighty)days from the date of filing of the corporate act registered with the board of trade or ofthe celebration of the contractual instrument of the commercial operation, or, in thecase of a representative Mercosur, will be counted from the date on which theinterruption of the contractual relationship between the parties contained in theDeclaration (Annex I of the RDC 102/2016) is formalized.b) 180 days: Companies will have a maximum of one-hundred and eighty (180) days tosell out the remaining stock of finished products after the entry into force of Resolutionsof cancellation and transfer of registration.c) 90 days: Resolutions of cancellation and transfer of ownership registration of productssubject to health surveillance addressed in this resolution shall come into force ninety(90) days after its publication and

In the current context of Brazilian public health, the effective detection and monitoring of notifiable diseases such as Dengue, HIV, COVID-19, Chikungunya, Zika Virus, monkeypox, and Leptospirosis represent a significant challenge and a unique opportunity.  The introduction of advanced in vitro diagnostic (IVD) devices into the Brazilian market is not only an urgent need but also an opening for commercial expansion. This text aims to demystify the regulatory landscape and highlight the strategic importance of deploying these devices in Brazil, pointing out to the CEOs of manufacturing companies the latent potential for development and leadership in the sector.  Overview of Notifiable Diseases and Their Impact on the Health System:  Brazil faces a complex dynamic of infectious diseases, with significant seasonal and geographical variations. The effectiveness of controlling these diseases necessarily passes through early and accurate diagnosis, which places IVD devices as crucial tools in public health management. The rapid identification of pathogens allows for targeted interventions and the implementation of control measures, reducing transmission and the impact on health resources.  IVD devices encompass a wide range of technologies, including rapid diagnostic kits, reagents, and automated platforms, capable of specifically detecting infection markers of various natures (viral, bacterial, parasitic). The introduction of molecular diagnostic platforms, for example, offers unprecedented sensitivity and specificity, essential for the diagnosis of infections like COVID-19 and Zika Virus, where the viral load and the presence of antibodies are critical indicators of the disease phase and the individual’s immune response.  ANVISA imposes strict criteria for the approval of IVD devices, ensuring their safety, efficacy, and quality. The risk classification of these devices indicates the degree of regulatory control needed. Although the regulatory process may seem intricate, it presents an opportunity for companies aiming to establish benchmarks of excellence and safety in innovative products. Navigating the regulation requires in-depth knowledge of the norms and constant dialogue with ANVISA, facilitating approval and market introduction. It is important to highlight Ordinance 204 of 2016, which establishes notifiable diseases, and according to RDC 830/2023, diagnostic products for these diseases are generally classified in classes III or IV, requiring Good Manufacturing Practice Certification for product registration.  The IVD device market in Brazil is vast, offering significant opportunities for innovative companies. With a population of over 210 million, the demand for advanced diagnostic solutions is growing, especially for notifiable diseases. Moreover, the ability to offer products adapted to Brazil’s epidemiological and infrastructural specificities can differentiate companies in the market, establishing them as leaders in innovation and strategic partnerships with the public and private sectors.  The integration of innovative IVD devices into the Brazilian health system is more than a necessity; it is a strategic opportunity for companies looking to lead the next wave of innovation in public health. Through a collaborative approach with regulators and continuous investment in technology and research, we can transform the landscape of diagnosis and control of notifiable diseases in Brazil, paving the way for a healthier and more resilient future.  We invite industry leaders to join us on this journey of innovation and impact.  Explore how your company can contribute to the transformation of disease diagnosis in Brazil and position itself at the forefront of global public health. Together, we can make a difference.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #IVD #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 

Navigating regulatory complexities in Brazil is a challenge for many companies, especially those operating in the healthcare field. In this context, understanding the differences between the Operating Authorization for Companies (AFE) and the Special Authorization (AE), as well as their applicability in registering products and services with the National Health Surveillance Agency (ANVISA), is crucial. This article seeks to clarify these differences and provide guidance on the applicability of each in the regulatory process.  What is AFE?  AFE is a mandatory license for companies involved in the production, distribution, storage, and transportation of products subject to health surveillance, including medications, food, cosmetics, sanitizers, among others. This authorization is issued by ANVISA and ensures that the company complies with the necessary technical standards and regulations for its operation. Obtaining the AFE is the first step for a company to start its activities in the healthcare sector.  What is AE?  Special Authorization (AE), on the other hand, is an additional requirement for companies intending to handle, store, distribute, or transport controlled products, including psychotropic substances, chemical precursors, among others. AE is, therefore, a complementary authorization to AFE, intended for a specific group of activities involving products with a higher level of control due to their potential risk to public health and safety.  Key Differences and Applicability:  The main difference between AFE and AE lies in the type of activity and products each company deals with. While AFE is broad and covers a variety of products subject to health surveillance, AE is specific to controlled products. This means that a company may only need AFE to operate, but if it decides to expand its activities to include controlled products, it will also need to obtain AE.  In the context of product registration with ANVISA, possession of AFE is a prerequisite for most processes. The company needs to prove its compliance with sanitary regulations before applying for product registration or notification. For controlled products, in addition to AFE, AE becomes an additional requirement, reinforcing the safety and control over these products.  Final Considerations:  Obtaining AFE and, when applicable, AE, is just the beginning of the regulatory compliance process for companies operating in the healthcare sector in Brazil. In addition to these authorizations, it is essential to stay updated with changes in legislation and technical standards, ensuring the continuity of operations and the safety of products offered to the market.  Understanding the difference between AFE and AE and their applicability is crucial for the success of companies in the healthcare sector and for the protection of public health. ANVISA plays a fundamental role in regulating and overseeing these activities, ensuring that only safe and effective products reach Brazilian consumers.  In the dynamic Brazilian healthcare sector, regulatory clarity and compliance are not just good practices – they are business imperatives. We hope this article has shed light on the path for your company to achieve not only compliance but also operational and market excellence.  Let’s navigate regulations together and pave the way for success in the healthcare sector!  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #ANVISA #ANVISA #AFE #AE  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 

ANVISA’s Regulatory Agenda is a fundamental pillar for predictability and the evolution of the regulatory environment in Brazil. Its relevance goes beyond the normative aspect, directly impacting the strategic business planning in sectors such as health, food, cosmetics, and technology.  Analyzing the trends and changes proposed in this document is essential for companies and entrepreneurs. This agenda defines the directions of regulations, indicating updates, revisions, and new norms that can affect the manufacturing, marketing, and distribution of products.  Deeply understanding the nuances of the Regulatory Agenda offers competitive advantages. Anticipating these changes allows for the adjustment of strategies, investment in research and development aligned with future regulations, and consequently, being ahead in launching innovative and compliant products.  Moreover, close observation of these guidelines can boost strategic partnerships, targeted investments, and the development of solutions that are in line with regulatory expectations, reducing risks and streamlining processes.  For companies, whether in the adaptation of processes or in the launch of new products, understanding the Regulatory Agenda is a competitive differentiator. It will not only mitigate risks but will also serve as a compass to navigate a dynamic and complex regulatory environment..  ANVISA’s Board of Directors (Dicol) approved on December 15, 2023, through the Deliberative Circuit – CD No. 1.312, the Regulatory Agenda for the next two years. Published by Ordinance No. 1409, the 2024-2025 Agenda consists of 172 regulatory themes distributed across 16 macro themes.  Among the highlighted subjects, Medicines (45 themes), Food (34), and Cross-Cutting Issues (23) receive greater attention. It is interesting to note that 62% of the themes are related to the previous Agenda, while 66 are new regulatory themes. Exploring the nuances of the new regulatory agenda, we observe key points that are transforming the regulatory landscape:  Innovation in Medical Devices: ANVISA is paving the way for innovations that will transform patient care. With a keen eye on emerging technologies, the regulator is shaping an environment conducive to the rapid and safe advancement of new medical devices.  In Vitro Diagnostic Devices (IVD): Currently, the sector faces a significant gap: the absence of legislation and clear criteria for the prior analysis of IVD devices. This   situation generates uncertainties, as the regulated sector lacks guidelines on how and when such analyses should be performed before the registration stage.  Electronic Instructions for Lay User Products: In response to a growing demand from the regulated sector, which seeks to optimize material and logistical resources and address environmental concerns, ANVISA is moving to allow instructions for use in electronic format for lay user devices. This change aligns with existing practices for professional use devices and reflects a commitment to sustainability and regulatory modernization.  International Harmonization: ANVISA is adopting a strategic approach to integrating the assessments of recognized international regulatory authorities into its own analyses of medical devices. This alignment promises to accelerate the Brazilian market’s access to global innovations and optimize the review process, making it more agile and effective.  In the 2nd stage (completed) of the process, contributions were analyzed and regulatory themes were prioritized and selected. The analysis of the 258 contributions from society resulted in 123 prioritized groups to compose the 2024-2025 Agenda, totaling 172 themes after the inclusion of 91 and exclusion of 21 in relation to the preliminary list.  For more details on ANVISA’s 2024-2025 Regulatory Agenda and its developments, check out the links:  Being updated and engaged in the discussion about ANVISA’s Regulatory Agenda is more than a legal requirement; it is a smart strategy for business success in an increasingly dynamic and regulated market.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #ANVISA #Regulation #Business #Innovation #Strategy #RegulatoryAgenda  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