The commercialization of medical devices (MD) in Brazil is regulated by ANVISA (National Health Surveillance Agency), which requires different levels of authorization depending on the type of product. Many companies and healthcare professionals often ask: what’s the difference between notification and registration? And how do risk classifications affect the regulatory process? Let’s explore these questions.  What are Notifications and Registrations with ANVISA?  Notification  Notification of medical devices is a simplified process aimed at low-risk products that pose minimal threat to user health. This is a faster regulatory path, requiring less documentation and a simpler regulatory review by ANVISA. However, this doesn’t mean notified products are exempt from safety and quality criteria.  Criteria for Notification: Notification applies mainly to Class I (low risk) products, and in some cases, Class II (low-medium risk) devices. For notification, devices must demonstrate that they are safe for their intended use and effective within acceptable safety and performance parameters. ANVISA requires basic data such as technical specifications, manufacturer identification, and compliance with national and international technical standards.  Required Documentation: When opting for notification, companies must submit a simplified dossier that includes:  Advantages: Notification is beneficial for lower-risk products, as the process is faster, with significantly shorter approval times compared to registration. Additionally, ANVISA’s review is less stringent, allowing notified products to enter the market more quickly.  Examples of Notified Products: Low-risk devices such as surgical gloves, syringes, digital thermometers, and bandages are usually subject to the notification process.  Registration  Registration, on the other hand, is mandatory for medium- to high-risk medical devices, requiring a deeper and more detailed review. Products that require registration must undergo a thorough evaluation of safety, efficacy, and technical compliance.  Criteria for Registration: Registration is required for Class III (medium-high risk) and Class IV (high risk) devices. These products have a more significant impact on patient health and life, demanding careful review of clinical evidence, manufacturing data, biocompatibility tests, performance studies, and clinical trials when applicable.  Required Documentation: The registration process is more rigorous and requires extensive technical documentation, including:  Approval Time and Evaluation: Registered products undergo a much more detailed review involving ANVISA’s specialized technical team, who evaluate safety, efficacy, and quality control. The approval time for registrations is significantly longer, often taking months depending on the complexity of the device and the dossier presented.  Examples of Registered Products: High-risk products such as pacemakers, defibrillators, orthopedic prostheses, dental implants, cardiovascular surgery devices, and life-support equipment (like ventilators) are required to go through the registration process.  Fundamental Differences Between Notification and Registration  Criterion  Notification  Registration  Risk Level  Low (Class I) and low-medium (some Class II)  Medium (Class III) and High (Class IV)  Process Complexity  Simple, fast, and with less documentation  Complex, demanding, and with more documentation  Required Documentation  Basic, including a declaration of conformity and basic technical data  Complete, including clinical studies, biocompatibility reports, and manufacturing certificates  Approval Time  Short, due to the lower complexity of the process  Long, as it involves a detailed ANVISA analysis  Product Examples  Surgical gloves, syringes, bandages  Pacemakers, stents, orthopedic prostheses  Medical Device Classification  ANVISA uses a risk classification system to determine the level of regulation required for each medical device. This system is based on the potential risk that the product may pose to the user.  Types of Medical Devices  Medical devices can be classified into several categories depending on their function and application. Key types include:  The Importance of Regulatory Compliance  Maintaining compliance with ANVISA regulations is essential for companies to safely and legally market medical devices in Brazil. Non-compliance can result in severe penalties, such as fines, product recalls, and damage to the company’s reputation. Additionally, regulatory compliance ensures that products offered to the end consumer meet international quality and safety standards, strengthening the confidence of patients, doctors, and other healthcare professionals.  For companies, correctly following notification or registration processes ensures the swift and efficient introduction of new products into the market while avoiding future bureaucratic obstacles. Compliance is also a competitive advantage in the healthcare sector, where the quality and safety of devices are crucial aspects.  Conclusion  Understanding the differences between notification and registration, as well as the risk classifications of medical devices, is fundamental to ensuring regulatory compliance and successful market entry in Brazil. ANVISA plays an essential role in evaluating the safety and efficacy of products, protecting public health, and ensuring the quality of medical devices available in the country.  Staying updated on regulatory requirements and adapting processes to current standards is an indispensable task for manufacturers and distributors of medical devices. For a more detailed comparison between ANVISA, FDA, and MDR classifications, you can read the article “Comparative Classification of ANVISA, FDA, and MDR: Understanding the Key Differences.”  Learn More  If you have any questions about the notification and registration process for medical devices or need assistance in ensuring regulatory compliance, contact Brisa Advisors. We are ready to assist your company at every step of the process.  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 No. 902, dated September 6, 2024, published by ANVISA, establishes that products subject to health surveillance that undergo changes in their composition must display the statement “NEW FORMULA” on their packaging. The labeling must be clear and prominent to consumers and can be applied using stickers. The resolution aims to ensure transparency regarding changes in products and imposes penalties for non-compliance with the regulations.  The products covered include:  Final Considerations  Resolution No. 902/2024 reinforces the importance of transparency in the composition of products subject to health surveillance, ensuring that consumers are properly informed about any changes. Implementing the “NEW FORMULA” expression in labeling is an important measure to ensure that consumers are aware of any modifications in the products they consume. The use of stickers is a viable alternative while labels are not yet updated, if conditions of integrity and legibility are respected. Non-compliance with the established requirements may result in penalties, emphasizing the need for attention to the new rules that will define implementation deadlines and specific guidelines.  📝 Access the RDC 902/24 :  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.  If you have 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 

The National Institute for Quality Control in Health (INCQS) plays a key role in ensuring that health-related products, including medical devices, meet stringent quality and safety standards in Brazil. INCQS certification is an essential process to ensure that these products are safe for use and comply with current regulations.Before we delve into the certification flow, we recommend that you check out the article Raising Standards: Unveiling the Pre-Analysis Evaluation Report by INCQS for Medical Devices”. This article details the INCQS pre-analysis report, which is a critical preliminary step to identify and correct potential issues prior to final certification. It offers insights into how this pre-analysis can improve the quality of medical devices and prevent future complications. Now, let’s explore the INCQS certification process step by step: Steps of the Certification Process Certification Request Request Review Technical Evaluation Issuance of Evaluation Report Certification Decision Issuance of the Certificate Monitoring and Surveillance Conclusion The INCQS certification process is a rigorous procedure aimed at ensuring the quality and safety of health products and services. Following this workflow helps ensure that all steps are completed efficiently and transparently, promoting consumer trust and the integrity of the healthcare system. Learn More For a deeper understanding of how the INCQS certification process can benefit your company and ensure consumer safety, contact the specialists at Brisa. They are ready to assist with your questions and guide you through every step of the certification process. Get in touch now and stay informed! 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 importation of medical device samples is a process that involves several stages and regulatory requirements. This process can be carried out in two main ways: via express courier import (simplified regime) or through the traditional direct import method via SISCOMEX (normal regime). Each of these methods has its own characteristics, which can impact the speed, complexity, and costs involved.  In this article, we will explore the step-by-step process of importing samples, highlighting the differences between the two regimes and addressing the applicable taxes in each case.  Step by Step Process for Importing Medical Device Samples  This regime is ideal for samples of lower value or volume. Simplified importation by courier is carried out by international carriers (such as DHL, FedEx, or UPS), being a faster and less bureaucratic process.  For samples of higher value, volume, or requiring specific registrations, traditional importation via SISCOMEX is more suitable. This process is more complex, requiring the formalization of the Import Declaration (DI) and compliance with all customs clearance stages.  After the inspection and compliance with all requirements, the Federal Revenue releases the goods to the importer.  Comparison Between Express Importation (Courier) and Importation via SISCOMEX  Aspect  Express Importation (Courier)  Traditional Importation (SISCOMEX)  Release Time  Fast (5 to 10 business days)  Slow (10 to 12 business days or more)  Documentation  Simplified  Complex  SISCOMEX Registration  Not required  Mandatory  Operational Cost  Higher per volume  Lower per volume  Cargo Tracking  Limited  Detailed  Taxation  Simplified (taxes included)  Calculated according to DI  Suitable for  Small and urgent samples  Larger and higher value samples  Conclusion  Choosing the correct import flow for medical device samples depends on the specific needs of the process, whether due to urgency or the type of product. Express importation is ideal for emergency situations, while the SISCOMEX route offers greater control and is more suitable for complex and higher-value cargoes.  For more details and guidance on importing medical devices and samples, contact Brisa Advisors for specialized regulatory support.  Find out more about BPO in RA!  The above text was collaborated on and reviewed by Alexandre Souza Rego.  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

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 

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