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