The Collegiate Board of the Brazilian Health Regulatory Agency (ANVISA) has announced an important update to the rules for the registration and importation of medications and vaccines aimed at combating Mpox, formerly known as monkeypox. The measure aims to streamline the regulatory process, facilitating access to treatments and vaccines, especially during outbreaks and public health emergencies.  This regulatory update represents a significant advancement as it seeks to eliminate bureaucratic obstacles without compromising the safety and efficacy of products. With this, ANVISA aims to ensure that the necessary products for combating Mpox reach the population more quickly, strengthening Brazil’s response to this global threat.  Among the key changes is the expansion of the applicability of the flexible rules, which were previously intended for medications and vaccines in specific situations. Now, this simplification will apply to a broader range of products, allowing innovative treatments and emergency solutions to be approved in record time.  Additionally, the regulation includes guidelines that facilitate the importation of products already authorized by other renowned international regulatory agencies. This means that medications and vaccines already approved in international markets can be more quickly accessible in Brazil, provided they meet the quality criteria established by ANVISA. This decision reflects the agency’s commitment to ensuring public health in Brazil, while adopting a swift and efficient approach to responding to new global health demands.  For more details on this regulatory update and its impact on the healthcare market, visit ANVISA ‘s website and stay informed about the latest regulatory news. For further information, 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 

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