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