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