Published in December 2019, RDC 327/2019 sets out the procedures for granting Sanitary Authorization for the manufacturing and importation of Cannabis-based products, as well as regulating aspects such as commercialization, prescription, dispensing, monitoring, and oversight of these products in Brazil .  Key Points of RDC 327/2019:  RDC 660/2022: Importation of Cannabis-Derived Products for Personal Use  RDC 660/2022, published in March 2022, focuses specifically on the importation of Cannabis-derived products by individuals for personal use, based on a medical prescription. This regulation is particularly relevant for patients needing products not available in the Brazilian market, allowing them to import directly .  Key Points of RDC 660/2022:  Correlation Between the Two RDCs  While both resolutions address the medicinal use of Cannabis, their focuses are different yet complementary:  pharmaceutical-grade quality and are accessible but under controlled and safe conditions.  Together, these resolutions create a solid and comprehensive regulatory environment that seeks to balance patient access to Cannabis treatments with control that the subject requires. the rigorous health   How the Authorization and Importation Processes Work  For companies seeking to enter the medicinal Cannabis market in Brazil, the journey begins with obtaining the AFE and AE, along with the specific Sanitary Authorization for each product. Companies must ensure that their products meet ANVISA’s defined quality and safety requirements. These rules include submitting technical documentation, conducting stability studies, and continuously monitoring the products post-commercialization .  Patients who need Cannabis products unavailable in Brazil can directly import them based on a medical prescription, following the registration and authorization process outlined in RDC 660/2022. This process allows patients to receive the treatments they need, provided the products come from regulated suppliers abroad .  Conclusion  The regulations established by RDC 327/2019 and RDC 660/2022 represent important milestones for access and control of medicinal Cannabis in Brazil. While RDC 327/2019 focuses on structuring the domestic market for Cannabis-based products, RDC 660/2022 allows patients access to international treatments, ensuring the continuity of medical care.  These regulations allow Brazil to advance in the field of medicinal Cannabis in a safe and controlled manner, promoting both industry development and patient well-being.  📝 Access the Resolutions RDC 327/2019 and RDC 660/2022:  EN Version – RDC 327/2019 and RDC 660/2022     The text in the original language of this announcement is the officially authorized version. The translations are provided solely for convenience and should refer to the original language text, which is the only version that has legal effect.  In case of doubts, please contact Brisa Advisors for specialized regulatory support.  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 September 2024, the Resolution of the Collegiate Board (RDC) No. 848, published by ANVISA, will come into effect, bringing new requirements for the registration, monitoring, and safety and performance evaluation of medical devices in Brazil. This new regulation aims to ensure that these products comply with safety and efficacy standards, protecting the health of patients and healthcare professionals. In today’s article, we will explore the implications of this resolution and how it affects the evaluation of medical devices.  RDC 848/2024: A New Regulatory Approach  The primary objective of RDC 848/2024 is to establish stricter and more detailed criteria to ensure that medical devices marketed in Brazil are safe and effective. The resolution aligns Brazil with international regulatory standards, such as those established by the European Union and the United States (FDA), ensuring that medical devices used within the national territory undergo rigorous evaluation processes. Among the changes brought by the RDC, the following points stand out:  Strengthening Safety Evaluation: The resolution reinforces the obligation of a thorough risk analysis, following the parameters of the ISO 14971 standard. Manufacturers must identify, assess, and mitigate all potential risks associated with the use of the medical device, with an emphasis on minimizing hazards for patients, healthcare professionals, and third parties.  Detailed Documentation: The new regulation requires the development of more robust technical reports, documenting all tests performed, results, and risk mitigation measures implemented. These reports will be essential for registration with ANVISA, as well as for future audits.  Clinical Validation and Performance Testing: In addition to the safety evaluation, the resolution focuses on proving the performance of medical devices. Functional tests, biocompatibility (ISO 10993), and clinical validations become mandatory for devices to meet regulatory requirements. This clinical validation must be conducted in controlled environments, with data demonstrating the device’s efficacy and safety in real-world use.  Medical Device Safety Evaluation  Safety is one of the central pillars of this resolution. The safety evaluation process involves several stages, including:  Risk Analysis: Using the ISO 14971 standard as a reference, the risk analysis is conducted to identify potential failures and hazards associated with the medical device. Each risk is assessed in terms of severity and likelihood of occurrence. Once identified, control measures must be implemented to mitigate these risks, with the effectiveness of these measures rigorously tested.  Compliance Testing: RDC 848/2024 mandates compliance with international safety standards, such as IEC 60601-1 for electromedical devices. These tests ensure that the device is safe in terms of electrical, thermal, and other exposures.  Biocompatibility Studies: RDC 848/2024 also reinforces the need for studies that prove the biocompatibility of materials used in medical devices. Following the guidelines of ISO 10993, these tests ensure that the device does not cause adverse reactions, such as toxicity or sensitization.  Medical Device Performance Evaluation  In addition to safety, performance evaluation also gains importance with RDC 848/2024. This evaluation aims to ensure that the medical device functions as expected throughout its lifecycle and meets clinical efficacy requirements. The performance evaluation involves:  Functional Testing: These tests verify whether the device performs the functions for which it was designed, even under different operating conditions. These tests also assess whether the device’s performance is maintained over time, ensuring consistency in its functionality.  Clinical Validation: Clinical validation involves studies in controlled environments, with the use of the device on patients. This process is crucial to provide direct evidence that the device is effective and safe in real-world use conditions.  Software Verification and Validation: In cases where the device includes software, the RDC requires the software to be tested according to IEC 62304 guidelines. This ensures that the software operates reliably, without compromising the safety and performance of the medical device.  Safety and Performance Evaluation Report  After completing all evaluation stages, the manufacturer must prepare an evaluation report that documents all findings, conclusions, and evidence of compliance. This report is essential for the device’s registration process with ANVISA and for meeting the regulatory requirements of RDC 848/2024.  Conclusion  RDC 848/2024 represents an important step in modernizing the control of medical devices in Brazil, requiring rigorous evaluations and complete documentation to ensure the safety and efficacy of these products. Compliance with international standards such as ISO 14971, ISO 10993, and IEC 60601-1 will be crucial to achieving and demonstrating this safety and performance.  If you work in the development or commercialization of medical devices, it is crucial to prepare for the new regulatory requirements, ensuring that your products comply with RDC 848/2024. For more details on the RDC and how it impacts the department, it is crucial that companies and professionals in the department are aware of these updates and adapt to the new requirements. Compliance with technical standards is essential to ensure approval of registration, notification, revalidation, or modification requests for equipment.  📝 Access the RDC 848/24 Normative Instruction:  The text in the original language of this announcement is the official authorized version. The translations are provided for convenience only and should refer to the text in the original language, which is the only version of the text that has legal effect.  In case of doubts, please contact Brisa Advisors for specialized regulatory support.  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

INMETRO certification is fundamental to ensuring that products and services comply with quality and safety standards in Brazil. This process is especially crucial for medical devices, which must meet strict standards to ensure user safety.  Before delving into the certification workflow, we recommend you check out the article “Compliance in Focus: How to Identify the Need for INMETRO Certification for Medical Devices“. This article provides valuable insights on how to identify the need for INMETRO certification for medical devices, highlighting regulatory requirements and the benefits of ensuring compliance.Below is a step-by-step guide to the process, including possible feedback in case of issues:  Objective: Identify which products or services need certification.  Action: Assess whether the product/service impacts consumer safety or health.  Objective: Select the best certification bodies accredited by INMETRO. Here at Brisa Advisors, we have partnerships and excellent relationships with certifiers who serve us faster and provide better support.  Action: Choose an organization with experience in the specific type of product or service.  Objective: Assist in organizing all the necessary documents for certification.  Action: Gather technical specifications, test reports, and other relevant information.  Objective: Formalize the certification request.  Action: Fill out forms and pay fees associated with the process.  Objective: Verify the compliance of the product or service with INMETRO requirements.  Action: Conduct laboratory tests and performance checks.  If non-compliance: Return to the Documentation Preparation stage for necessary adjustments.  Objective: Ensure that manufacturing processes meet quality standards.  Action: Conduct an audit at the factory or production site.  If issues in the audit: Return to the Initial Evaluation and Compliance Testing stage for correction.  Objective: Review the results of tests and audits.  Action: Issue a final report with the certification decision.  Objective: Formalize that the product or service meets the required standards.  Action: Issue the official INMETRO certificate.  Objective: Ensure that the certification remains valid over time.  The validity of the conformity certificate is usually three years but may vary depending on the type of device and specific applicable regulations. After the validity period ends, a new certification process is required to renew the certificate.  Action: During the validity period of the certificate, it is common for the manufacturer or importer to undergo follow-up audits to ensure that the device continues to comply with regulatory requirements.  If not renewed: Return to the Issuance of the INMETRO Certificate stage to start a new cycle.  📑 Learn More  For a deeper understanding of how the certification process can benefit your company, ensure consumer safety, and for more information on the certification of medical devices, contact the specialists at Brisa. They are ready to help with your questions and guide you through the certification process.  Access now and stay informed about everything!  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 healthcare market faces constant challenges and opportunities. One of the most effective strategies for optimizing resources and improving efficiency is the use of Group Purchasing Organizations (GPOs). This concept has revolutionized purchasing management in the healthcare sector worldwide.  In this article, we will explore the differences and similarities between GPO models in Brazil and the United States.  What are GPOs?  A GPO is an entity that unites multiple institutions or purchasing entities to collectively negotiate purchase contracts with suppliers. The primary goal of GPOs is to achieve economies of scale, allowing participating institutions to purchase products and services at more competitive prices and with better contract terms than they could individually. These organizations are common in sectors such as healthcare, education, government, and industry, facilitating not only cost savings but also product and process standardization and promoting operational efficiency.  GPOs in Brazil  In Brazil, GPOs are in the early stages of development, with no significant noteworthy success stories yet. However, this practice has great potential to transform purchasing management in the healthcare sector.  Brazilian GPOs have everything they need to grow and consolidate in the coming years, and this is why we at Brisa Advisors are thoroughly studying the market and talking with suppliers and buyers to stimulate the growth of this business model.  GPOs in the USA  In the United States, Group Purchasing Organizations (GPOs) are highly developed and play a crucial role in cost management and improving efficiency in the healthcare sector. With a robust infrastructure and a constant focus on innovation and quality, American GPOs are extremely effective in reducing costs and optimizing resources. They serve as an exemplary model for other countries looking to implement or enhance their own group purchasing organizations.  Key Differences and Similarities between Brazil and the USA  Table 1 below offers a clear view of the differences and similarities between GPO models in Brazil and the United States, highlighting key aspects such as structure, benefits, challenges, and impact on the healthcare departament.  Aspect  Brazil  USA  Main Entities  Still nascent, but initiatives like NonStop Import exist  Premier Inc., Vizient, HealthTrust  Adoption and Participation  Growing, voluntary, varying levels of adoption  Widespread, common among private and public institutions  Structure and Operation  Growing, still consolidating  Highly developed and structured  Main Benefits  Cost reduction, quality improvement  Cost reduction, access to products and innovations, additional support  Sustainability of philanthropic and private institutions  Data analysis, benchmarking, supply chain management consulting  Challenges  Regulatory and infrastructure challenges  Contractual complexity, regulatory compliance  Developing collaboration culture  Strict regulatory pressures  Success Stories  Strategic partnerships, cost reduction, efficiency  Substantial savings, improved operational efficiency  Growing interest and participation from hospitals  Standardization of processes and products, knowledge sharing  Sector Impact  Potential to transform healthcare purchasing management  Established model, vital for financial sustainability  Conclusion  In conclusion, the comparison between GPOs in Brazil and the United States reveals significant differences in the development and structure of these organizations. While Brazil is beginning to explore the potential of GPOs through isolated initiatives, the United States has already established a robust and efficient model with well-consolidated GPOs like Premier Inc. and Vizient. Both countries face unique challenges but share the common goal of improving efficiency and reducing costs in the healthcare sector. As we move forward, learning from each country’s experiences can inspire new approaches and international collaborations that further benefit healthcare purchasing management globally.  📢 Let’s Discuss!  What are your experiences with GPOs in the healthcare sector? How do you see the future of group purchasing in Brazil? Share your thoughts and let’s enrich this discussion!  At Brisa Advisors, we are committed to monitoring and analyzing regulatory and market trends shaping the healthcare sector. The evolution of GPOs represents a unique opportunity to positively transform hospital management. Let’s explore together how these strategies can impact the future of healthcare in Brazil and beyond!  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 

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