The RDC 938/2024 resolution, published by Anvisa, introduces significant updates to the Good Storage Practices (GSP) for goods and products subject to health surveillance in bonded warehouses. Effective from March 3, 2025, this regulation replaces RDC 346/2002, aiming to enhance safety, quality, and efficiency in the country’s logistics operations.  Below, we explore the resolution’s key points, its impacts on the industry, and the necessary steps for compliance.  What Does RDC 938/2024 Establish?  RDC 938/2024 sets out clear and comprehensive guidelines for the storage of goods and products under health surveillance. It addresses aspects such as Quality Management System (QMS) implementation, infrastructure requirements, documentation, and training.  Scope:  Objectives:  Key Requirements of RDC 938/2024  The resolution introduces significant changes that will require operational adjustments from companies. Below are the highlights:  1. Quality Management System (QMS)  Companies must implement a robust QMS to monitor all stages of the storage process. This system should include:  2. Infrastructure and Facilities  Warehouses must meet the following specifications:  3. Temperature-Sensitive Products  Products sensitive to temperature require special attention. The resolution demands:  4. Qualification and Validation  All equipment and computerized systems impacting quality must be qualified or validated. This includes:  5. Documentation and Records  The resolution emphasizes strong document management practices:  Impacts on Companies  Compliance with RDC 938/2024 requires a comprehensive review of operations and investments in infrastructure, technology, and training. Key challenges and opportunities include:  Deadlines and Penalties  Anvisa has set specific deadlines for company compliance:  Non-compliance may result in:  How to Prepare?  To ensure compliance with RDC 938/2024, companies should:  Conclusion  RDC 938/2024 represents a significant advancement in the safety and efficiency of Brazil’s logistics sector. While the requirements are demanding, they also present opportunities for companies to enhance their operations and stand out in the market.  Adopting Good Storage Practices is not just about compliance—it’s about competitiveness and a commitment to quality.  📝 Access the translated version of RDC 938/22  RDC Nº 938/2024     The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.  Click the link to access the Original Version    For any questions, 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 

Brisa Advisors made its mark at MEDICA 2024, the world’s largest medical industry event, held from November 11 to 14 in Düsseldorf, Germany. This event showcased the latest advancements in medical devices and innovative technologies, offering an inspiring glimpse into the future of healthcare.  More than just exploring the vast exhibition space, we leveraged MEDICA 2024 as a strategic platform to strengthen connections and expand our horizons:  These interactions reaffirmed our commitment to excellence and innovation. Armed with the knowledge and connections gained, we are ready to transform these insights into even more impactful solutions for our clients and partners worldwide.  Click here to learn more about the event: https://brisa.com.br/brisa-advisors-at-medica-2024-connecting-innovations-to-the-brazilian-medical-device-market/  For any questions, 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 

1. What is RDC 488/2021 and its Purpose?  RDC 488/2021 was established to regulate the importation of health products subject to sanitary surveillance by healthcare units, aiming to address specific needs in patient care, diagnosis, treatment, and rehabilitation.  Key aspects of the resolution include:  2. Who Can Import and Under What Conditions?  The importation governed by RDC 488/2021 can be performed by:  Important conditions:  Permitted Modalities:  3. Required Documents for the Importation Process  To proceed with importation, the following documents are essential:  Electronic document submissions require a digital signature with an ICP-Brasil certificate to ensure security and authenticity.  4. Exceptions: Non-Registered Products in ANVISA  RDC 488/2021 allows for the exceptional importation of non-registered products, provided the following conditions are met:  If the product has been previously authorized by ANVISA, the request analysis may be expedited based on prior decisions.  5. Impacts and Benefits of RDC 488/2021  This resolution offers significant benefits, such as:  However, strict adherence to the rules by all parties involved is crucial to avoid sanitary violations and ensure compliance.  Conclusion  RDC 488/2021 represents a major advancement for the healthcare sector, balancing speed and safety in product importation. For healthcare units and regulatory professionals, understanding and correctly applying the guidelines of this resolution is essential to providing quality medical care while adhering to legal requirements.  If you wish to learn more about implementing RDC 488/2021 in your professional context, consult experts or access the full text of the resolution here.  📝 Access RDC No. 488/2021  RDC Nº 488/2021    The text in the original language of this announcement is the only official and authorized version. Translations are provided solely for convenience and should refer to the original language text, which is the only version with legal effect.  For any questions, 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 

The Brazilian Health Regulatory Agency (ANVISA) has published RDC No. 938/2024, establishing new provisions for Good Storage Practices (GSP) and regulating certification for bonded warehouses handling goods and products subject to health surveillance. The regulation will take effect on March 3, 2025, and has the potential to raise safety and quality standards in the logistics sector.  Key Points of RDC No. 938/2024  Scope and Applicability  Quality Management System (QMS)  Infrastructure and Storage  Staff Training  Documentation and Records  Good Storage Practices Certification  RDC No. 938/2024 introduces a voluntary certification for Good Storage Practices, valid for four years. This certification fosters:  Companies seeking certification must demonstrate full compliance with the technical requirements outlined in the regulation.  Deadlines and Adjustments  The regulation establishes critical deadlines for implementation:  Why Is This Resolution Important?  RDC No. 938/2024 aligns Brazil with international storage and health surveillance standards, promoting:  Conclusion  Compliance with RDC No. 938/2024 represents a milestone for Brazil’s logistics sector, requiring collective efforts from companies to implement structural and managerial changes. Pursuing voluntary certification, beyond merely meeting the requirements, can set organizations apart and ensure their relevance in the global market.  📝 Access RDC No. 938/2024  RDC Nº 938/2024    The text in the original language of this announcement is the only official and authorized version. Translations are provided solely for convenience and should refer to the original language text, which is the only version with legal effect.  📎 Click the link to access the Original Version  For any questions, 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 

We are thrilled to announce that Brisa Advisors will be attending MEDICA 2024, the world’s largest event in the medical sector, taking place from November 11 to 14 in Düsseldorf, Germany. With over 40 years of history, this fair is a milestone on the calendar of specialists and is the largest global gathering of healthcare professionals, researchers, and business and political leaders. MEDICA brings together thousands of exhibitors from more than 50 countries and offers an extensive range of product categories, including imaging/diagnostic technology, laboratory equipment, diagnostic tests, physiotherapy/orthopedic technology, disposables, IT systems and solutions, and medical services. The event also includes a series of forums and conferences addressing medical technology topics, such as the MEDICA CONNECTED HEALTHCARE FORUM with the MEDICA START-UP COMPETITION, MEDICA HEALTH IT FORUM, MEDICA ECON FORUM, and MEDICA TECH FORUM. Highlights also include the German Hospital Conference, the MEDICA MEDICINE + SPORTS CONFERENCE, and the International Conference on Disaster and Military Medicine (DiMiMED). Why is MEDICA so vital? 🌍 Global Insight: The event brings together health experts and professionals from around the world, providing a global perspective on best practices and innovations in medicine. 🔬 Innovation: Advances in medical technology, groundbreaking devices, and cutting-edge healthcare solutions are showcased. This is where the most revolutionary ideas come to life. 🤝 Powerful Networking: MEDICA fosters an environment to establish valuable connections with peers, form strategic partnerships, and collaborate on projects that can change how healthcare is delivered. 📚 Continuous Learning: The outstanding educational program covers topics that shape modern medicine. Knowledge gained here can inspire significant innovations and advancements. As a market access and regulatory compliance specialist with ANVISA, Brisa Advisors provides essential support for companies interested in expanding into Brazil, ensuring a safe and competitive market entry process. If you wish to bring your products to Brazil with a reliable and efficient structure, schedule a meeting with us at MEDICA to explore the strategies Brisa Advisors can offer for your success in the Brazilian market. During MEDICA, our team will be available to discuss how we can assist your company—from selecting optimal sales channels to obtaining regulatory approvals and achieving effective commercialization. Book a meeting with us and discover how to accelerate the entry of your medical devices into Brazil. We look forward to seeing you at MEDICA 2024! Click to schedule your meeting For any questions, 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 

The Brazilian Health Regulatory Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices in Brazil through RDC 608/2022. This regulation marks a significant step forward in enabling access to innovative medical technologies for patients with serious conditions and no satisfactory therapeutic alternatives. What is Compassionate Use? The Compassionate Use Program allows access to innovative medical devices not yet registered with ANVISA for patients with serious, debilitating illnesses. This program is especially valuable when no satisfactory therapeutic options are available in the country. Eligibility Criteria For a patient to qualify for the Compassionate Use Program, three conditions must be simultaneously met: Responsibilities of the Sponsor The program sponsor holds several key responsibilities: Role of the Attending Physician The attending physician plays a crucial role in the program, being responsible for: Patient Protection The regulation includes various safeguards to protect patients: Timeline and Monitoring The program has a maximum duration of 5 years for patient inclusion, beginning with the enrollment of the first participant. The sponsor must submit annual reports to ANVISA on the program’s progress and a final report within 90 days of program completion. Final Considerations The Compassionate Use Program represents a vital pathway for accessing innovative medical technologies for patients in critical situations. This regulation strikes a balance between the need for new treatments and patient safety, with clear responsibilities for all parties involved. For further information on the Compassionate Use Program for medical devices, consult RDC 608/2022 in full or contact ANVISA. 📝 Access RDC 608/22  RDC Nº 608/2022        The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.  Click the link to access the Original Version  For any questions, 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