Hosting, Registry Maintenance & Regulatory Compliance Hosting │ BRH The Brazilian Registration Holder (BRH , also known as Host or Hosting service provider ) – in Portuguese “detentor do registro ” – is the company that “owns” the registration and responds directly to ANVISA as the entity legally liable for the medical device in Brazil. The BRH possesses the right to sell and distribute your devices in the Country and is responsible for ensuring the quality and safety of your products in the Brazilian territory. The BRH’s responsibility doesn’t end when the registration is granted . The BRH is also responsible for continuously monitoring the product use, answering to complaints, issuing warning and field actions, keeping the document repository updated, acting as a link between the manufacturer, ANVISA and the users, emitting import and distribution authorizations, etc. So, you need to truly trust your BRH and count on them for sustainable growth. Document Repository In 2020, ANVISA created an online repository for publicly storing and accessing digital documentation of medical devices. With Resolution RDC 751/2022, registration holders are required to add their medical device’s Instructions for Use (IFU) to the repository and ensure that this information is kept updated. The BRHs of newly registered medical products or of previously registered products that undergo changes must ensure that the product’s IFUs are added to Anvisa’s online repository within 30 days of these being published in the Official Federal Gazette (DOU). It is important to note that any public advertising or communication regarding medical devices must be consistent with the information submitted to ANVISA by the BRH. Registry Maintenance & Regulatory Compliance Product Registration Certificates are valid for 10 years and the renewal application must be submitted in a timely manner. Any post-approval changes made to the medical devices must be sent to Anvisa, with relevant documents according to the current requirements. As part of our daily routine, QualiThings follow all official publications, keeping updated with the latest news and regulatory changes. How we can help How we can help How we can help How we can help More Than Just a BRH Where most Brazilian Registration Holders focus only on the registration processes and others only on sales, we work with Regulatory Affairs, Quality Assurance and all aspects related to nationalization, distribution, and commercialization of medical devices. Boutique Services We work as a boutique office with modular services - our clients are free to make their own decisions and pick-and-choose which services they want to hire. Network of Partners We can connect you with our network of partners, distributors, and clients, to expedite market growth. Flexibility to Transfer or Change Distributors Brazilian legislation allows the BRH to give import permits authorizing the distributor(s) of your choice to import your devices, which means you will have full control over your registration, your technical documents, and your products. Keep your Company and Product Compliant We can timely alert the foreign companies in case any prompt action is required to maintain the product registration valid and avoid penalties. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

Additional Certification INMETRO Certification The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) mandates accredited Certification Bodies (OCP/CB) to conduct certification. In February 2022, INMETRO launched its new regulatory framework which is more aligned with international best practices. The framework reduces the number of products under regulation, so that only products with a safety or environmental concern remain covered, allows for a greater use of self-declaration of suppliers and producers, when appropriate, as well as on the acceptance of international tests. INMETRO certification is mandatory for all electro medical devices subject to IEC 60601, PPEs, needles, syringes, breast implants, condoms, and some other products. Minimum documentation required for initial INMETRO certification: Quality Manual Packaging and Labelling Risk Management Software Validation, when applicable Usability Test Report Electric Schematics, when applicable List of Critical Components Diagram of Isolation, when applicable Customer Complaints Tests performed overseas are usually accepted. So, instead of sending the medical device to Brazil, this option can help foreign companies save cost and time. After certification and approval by Anvisa, the medical device must bear an INMETRO label. The INMETRO certificate doesn’t expire, but the manufacturer must undergo an annual maintenance inspection by the certification body. ANATEL Certification The Agência Nacional de Telecomunicações (ANATEL) certificate applies to medical devices that use radiofrequency (RF) spectrum or wireless communication, e.g. Bluetooth, Wi-Fi, etc. For this certification, the device must be sent to Brazil for tests. Steps for ANATEL Certification and Homologation: How we can help How we can help How we can help How we can help Evaluate if Additional Certification is Required We will determine whether any local certification requirements apply to your device, such as ANATEL or INMETRO certification. Bridge the Gap We will review the required documents and help you bridge any gaps for rapid and successful certification. Network of Partners We can connect you with our network of partners and specialists to expedite the certification processes. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

Market Authorization: Registering a Medical Device Document Compilation - The Technical Dossier After defining the product’s grouping, risk class and type of registration (Notificação or Registro ), it is necessary to gather the mandatory technical documents and submit them to Anvisa for evaluation. The Technical File, also known as Technical Dossier or “Dossiê Técnico ”, is the regulatory bundle that presents the medical device characteristics, intended use, mechanism of action, potential risks, manufacturing processes and additional information. It shall include IFUs, labeling, packaging, clinical information, and the List of Essential Safety and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho ). This is in alignment with the International Medical Device Regulators Forum (IMDRF) guidance. The technical dossier must be structured and organized as described in RDC 751/2022 (Annex II) and according to the product's risk class . For those RA experts who are familiar with compilation of European MDR Technical Documentation Files or IMDRF-compliant documents, this should be a similar experience; however, knowledge on device grouping and other Brazilian legal requirements is paramount. Notification (“Notificação”) Anvisa’s authorization for risk class I and II devices is achieved through a simplified process. The product's technical dossier, proposed labeling, and instructions for use in Portuguese, must be submitted to Anvisa for analysis. Class I and II notifications do not expire but must be reviewed periodically, as they might be canceled upon request in case of reassessment, irregularities, or when fraud is observed. Registration (“Registro”) Risk class III and IV medical devices must take a regulatory route which requires BGMP certification prior to product’s authorization. This includes submitting to Anvisa a complete technical dossier containing clinical data, biocompatibility studies, performance tests, etc. Class III and IV registrations are valid for 10 years and may be renewed for equal and successive periods. After compilation of documents, the dossier (in Portuguese) must be submitted to Anvisa for approval . The submission of documents to Anvisa must be made in electronic format through Anvisa‘s Electronic Petitioning System. Our company has the knowledge and expertise to prepare the product’s technical dossier and to assist you with every step of the preparation and submission of your application – for all risk classes ! From the “easy” class I devices to the “more difficult” class IV high-risk electronic devices. We will also accompany the progress of the petition and act proactively for fast and reliable solutions. Responding to ANVISA's Requirements After document submission, Anvisa will evaluate if the product’s dossier is complete and if the medical device is proven to be effective and safe. If the Anvisa’s officers find the dossier incomplete or if any questions arise, they will issue a request called “exigencia ” (requirement upon incompleteness). The next obstacle is replying to Anvisa’s requests in a timely manner, which relies majorly on the legal manufacturer’s ability to provide the documents and answers as quickly as possible. With organized and strategic product registration, there is no doubt of successful approval in the end. Market Authorization When ANVISA is satisfied with the contents presented, they will approve the request and issue the market authorization (notification or registration) number for the device. This approval is published in the Official Federal Gazette (DOU). The market authorizations for class I and II medical devices don’t expire. The product certificate for class III and IV medical devices is valid for 10 years. How we can help How we can help How we can help How we can help Prepare Technical Dossier We will review the technical information, intended use, and claims for your device, ensuring proper classification and grouping before beginning the registration process. Direct Contact with Anvisa We will communicate with Anvisa on your behalf during and after the registration process as needed. Regulatory Strategy Our in-depth knowledge of the Brazilian medical device market allows us to provide the most efficient and cost-effective regulatory strategy for your devices. Monitor the Petition Our team will closely monitor the progress of your petition and take proactive steps to ensure fast and reliable solutions. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

Regulation of Medical Devices in Brazil Brazil is the largest medical device market in Latin America and has a well-established but complex regulatory system. The Brazilian medical device market has an attractive potential – currently, it is worth approximately US$10.5 billion, and imported medical devices account for 80 percent of the market. ANVISA, the Brazilian Health Regulatory Agency, is responsible for monitoring medical devices, as well as drugs, pesticides, food, cosmetics, sanitizing agents, pharmaceutical supplies, blood, tissues and organs, pharmacies and drugstores, ports, airports and borders, and tabaco. ANVISA keeps the Brazilian regulatory framework up-to-date at international level. In 2012 it co-founded the International Medical Device Regulators Forum (IMDRF). The most important regulations (laws, decrees, and others) can be accessed below: Access Access ANVISA’s online compilation of regulations Request Request the English version

Quem Somos A resposta para seu sucesso A QualiThings é uma empresa especializada e com profundo conhecimento do intrincado mercado de produtos médicos no Brasil. Nossos especialistas se destacam em fornecer soluções personalizadas. Estamos aqui para compartilhar nossa expertise com empresas estrangeiras e auxiliá-las em sua trajetória no mercado brasileiro. Entrar num novo mercado traz múltiplos desafios, especialmente para fabricantes de produtos altamente regulamentados, como dispositivos médicos. Mas com um planejamento cuidadoso e assistência adequada, empresas de todos os portes podem ter oportunidades de negócios frutíferas e sucesso no mercado brasileiro. Na verdade, as potenciais recompensas superam quaisquer desafios. Nosso time Patricia Huber Chief Quality Officer & Founder Mrs. Huber’s exceptional skills and true passion have driven remarkable growth within the company. With over 20 years of experience in the healthcare sector, she brings deep expertise as a Clinical Pharmacist and in RA/QA, supported by a Master’s degree in Pharmaceutical Sciences and an MBA in Quality and Process Management. Working with strong motivation and a results-oriented mindset, our Regulatory Affairs Specialist and Chief Quality Officer has been instrumental in strengthening compliance, optimizing processes, and guiding the company to where it is today.

Packaging, Labeling & Marking Requirements The Brazilian Customer Protection Code requires that product labeling provides the consumer with precise and easily readable information about the product’s quality and quantity, composition, shelf life, origin, and risks to the consumer’s health and safety. All imported products must bear labels containing this information in Portuguese and indicate the brand or name of the manufacturer. Labels should include metric units or a metric equivalent. In addition, ANVISA and INMETRO have their own set of rules concerning product labeling and marking. Labeling rules and IFUs provide important information about the product, such as its contents, indications, warmings, and storage conditions. Most cases of imported products that suffer market restrictions by ANVISA, such as recall, withdrawal, suspension of sales and use etc. are due to labeling discrepancies, mislabeling, or irregular labeling . Therefore, ensuring compliance with labeling requirements is of upmost importance . ANVISA Regulations on Packaging and Labeling As per Resolution RDC 751/2022, medical devices must include on their labels several important information in Portuguese , such as: In addition, all medical devices must include Instructions for Use (IFU) in their packaging. The IFU may not be included, exceptionally, in the packaging of class I and II products, as long as the safe use of these products can be secured without such instructions. If a medical device is reusable , it is required to display information on appropriate reuse procedures, including cleaning, disinfection, packaging and the sterilization method, when applicable, and any restrictions on number of reuses. Resolution RDC 156/2006 establishes additional labeling provisions regarding the inclusion of statements such as “reprocessing is forbidden ” or “single use recommended by the manufacturer ”, and the rules for when these sentences must or mustn’t be included. Manufacturing and expiration dates; When applicable, the indication that the medical device is for single-use only; The specific storage, conservation, and handling conditions; Notification or registration number; ... Among others. Name and address of the legal manufacturer and of the notification or registration holder; The necessary information for the user to identify the medical device and the contents; When applicable, the word "Estéril" (“Sterile”) and the sterilization method; Lot, batch, or serial number, as appropriate; Traceability Labels Resolution RDC 556/2021 establishes the addition of traceability labels or tags for implantable medical devices. The manufacturer or importer must provide at least 3 traceability labels to identify each implantable material or component. The traceability labels must include at least the following information: product name, identification of the manufacturer or importer, product code, batch number, the ANVISA registration number, and in some cases, the UDI support. UDI The provision for the identification of medical devices through the Unique Medical Devices Identification (UDI) system is set by Resolution RDC 591/2021. This system is being adopted by ANVISA for the identification of medical devices in the Country and applies to all devices regulated by Anvisa, except custom-made medical devices and medical devices under clinical investigation. UDI is a numeric or alphanumeric character string created through worldwide accepted device identification and coding standards, that allows for the unambiguous identification of a specific device on the market. The UDI system is designed to provide a unique identification, globally harmonized, for the identification of medical devices during their distribution and use, which requires labels to carry a unique device identifier linked to a public UDI database. The UDI database is an electronic system that contains information and other identification elements associated with a particular medical device through its UDI number. Examples of UDI supports are: linear barcode, matrix/two-dimensional (2D) barcode, QR code, RFID. The manufacturer's quality management system shall implement control mechanisms to ensure the correct assignment of the UDI to all devices manufactured by it or on its behalf; hence, it is the manufacturer’s responsibility to assign the UDI to the product. The notification or registration holder is responsible for submitting and transferring the data to the UDI database and for ensuring the consistency and validity of this information. Before placing a device on the market, the manufacturer shall assign to the device and, where applicable, to all upper packaging levels, an UDI created in compliance with the rules of the issuing entity designated by Anvisa. The UDI supports shall be placed on the label or on the device itself , and on all upper packaging levels. Resolution RDC 591/2021 came into force in January 2022 and was amended by RDC 884/2024 in June 2024. The deadline for manufacturers to attribute and affix UDI to their medical devices are escalated based on the risk class and calculated from the effective date of RDC 591/2021, as follows: Compliance with the provisions of Resolution RDC 591/2021 is optional for the medical devices manufactured prior to the deadline; and will be mandatory afterwards. How we can help How we can help How we can help How we can help Compliance Confirmation We will ensure that packaging, labeling and markings are in accordance with the specifications established by Anvisa, INMETRO, and the Brazilian laws. Avoid Penalties To avoid any unforeseen penalties, we will elaborate the labeling and IFUs according to the Brazilian standards and translate the contents to Portuguese. Maximize Your Product's Potential We will evaluate the feasibility of reusing the device in Brazil and guarantee that classification during the registration process is executed accurately. Stay Updated We shall inform you regarding any changes in the legislation and upcoming deadlines in a timely manner, thereby ensuring that you have sufficient time to prepare adequately. Strategies for Reusable Medical Devices Devices that can be reprocessed are welcome in Brazil and have high demand. Our knowledge of the Brazilian medical device market and our experience in registering reusable products give us the advantage of identifying and recognizing these devices, registering them in the right manner, and distributing them widely. Best Market Opportunities We can identify the best market opportunities and registration strategies for single-use and reuse medical devices. Reuse and Reprocessing Techniques We can assist you in the preparation of booklets and technical materials about reuse and reprocessing practices. Compliance with UDI requirements We will help your company through the steps to correctly assign unique codes to your devices and ensure compliance with UDI requirements. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

4PL Solutions & Product Distribution What is 4PL? Fourth-Party Logistics (4PL) services have a role of integrating , collaborating , and overseeing the supply chain by managing the transportation , storage , and distribution of the products from the manufacturers to the end users. 4PL works in a neutral way, taking over the management of the logistics process regardless of the suppliers, transports, and warehouses used. Advantages of Using 4PL Considering that traditional outsourcing partnerships tend to focus solely and exclusively on cost reduction and resource transfer, the 4PL agent assumes a fundamental role in the supply chain , working as a link between the supplier and the customer , promoting integration in the supply chain by increasing benefits for both, and reducing costs through the search for greater efficiency and effectiveness in processes. Moreover, 4PL can add value in the communication and coordination relationships between the various service providers, allowing the manufacturers to pay full attention to their core business . It is in the context of health products that 4PL brings the most impact, as the provision of high-quality care and patient safety heavily rely on the availability of essential medical devices in the healthcare setting. Main Features We at QualiThings have the intellectual capital , technological capacity , and management tools that enable us to manage the entire logistics process . 1 Reduction of operational logistics costs 2 Knowledge of the supply chain 3 Strategic relationships 4 Adaptability, collaboration and flexibility 5 Neutral approach in the selection of service providers 6 Technological capacity QualiThings can assist foreign manufacturers by creating distribution strategies in the Brazilian market through distributors or distribution centers specialized in health products. The company has numerous partners throughout Brazil, which allows us to ensure that products are delivered to their locations in adequate condition in a timely manner. We have the ability to reduce delivery times while benefiting customers. How we can help How we can help How we can help How we can help Connect with Distributors We can connect you with our network of distributors scattered across the country, or with the distributors of your choice. Timely & Secure Delivery We provide efficient logistics, securing that your product is properly delivered to the intended recipients, through the concept of Fourth-Party Logistics (4PL). Transportation We make sure that your MD is transported safely, efficiently, and timely to the end user, wherever they are. This may involve various transportation modes, including ground, air, and sea, depending on the distance and urgency of delivery. Warehousing & Inventory Management We ensure that your product is stored under your specific storage conditions in warehouses with controlled environments, such as temperature and humidity control, and manage inventory effectively, including tracking expiration dates and lot numbers. Packaging & Labeling We ensure that your medical devices are packaged securely to prevent damage during transport and labeled accurately with essential information, which are crucial to maintain their safety and regulatory compliance. Regulatory Compliance We ensure that all operations are in compliance with transportation regulations, customs clearance procedures, documentation, and quality standards set by the regulatory bodies. Track & Trace We use technologies to track and monitor the movement of medical devices throughout the supply chain, from origin to destination, which is vital for transparency, accountability, and to ensure timely delivery. Reverse Logistics In case of product recalls, withdrawals, returns, or expired devices, we can manage the reverse logistics process, which involves collecting the devices from healthcare facilities, coordinating returns, and ensuring proper disposal according to environmental and sanitary guidelines. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

BEM-VINDO À QUALITHINGS Garantia da Qualidade e Assuntos Regulatórios t para Empresas de Dispositivos Médicos Sobre nós A QualiThings é uma empresa especializada e com profundo conhecimento do intricado mercado brasileiro de dispositivos médicos. Nossos especialistas se destacam na entrega de soluções personalizadas . Estamos aqui para compartilhar nossa expertise com empresas de todos os portes e auxiliá-las em sua trajetória no mercado brasileiro. Saiba mais Podemos atuar como um elo entre sua empresa e a Anvisa A legislação brasileira estabelece que apenas empresas nacionais podem registrar dispositivos médicos, e essas empresas devem possuir licenças sanitárias locais e federais. As empresas estrangeiras que desejarem registrar seus produtos no Brasil deverão ter uma empresa parceira legalmente constituída no Brasil, como a QualiThings, que será detentora da autorização emitida pela Anvisa e legalmente responsável pelos produtos importados e distribuídos no território brasileiro. Podemos atuar como um elo entre sua empresa e seus clientes Nomear um representante junto à Anvisa dá mais flexibilidade e controle sobre seus produtos do que nomear um distribuidor para essa função. Isso significa que não há necessidade de escolher um distribuidor previamente: você pode iniciar seu processo de cadastro enquanto conhece o mercado brasileiro e conhece os distribuidores. A legislação brasileira permite que o detentor do registro conceda licenças de importação autorizando o(s) distribuidor(es) de sua escolha a importar seus dispositivos. Como podemos ajudar Âncora 1 Entrar num novo mercado traz múltiplos desafios, especialmente para fabricantes de produtos altamente regulamentados, como dispositivos médicos. Mas com planejamento cuidadoso e assistência adequada, empresas de todos os portes podem ter oportunidades de negócios frutíferas e ter sucesso no mercado brasileiro. Na verdade, as recompensas potenciais superam quaisquer desafios . Registo de Produto & Autorização de Mercado Nossos especialistas podem elaborar o dossiê técnico do produto, que inclui uma ficha técnica completa contendo dados clínicos, estudos de biocompatibilidade, testes de desempenho, instruções de uso e demais documentos exigidos pela Anvisa. Armazenamento, Distribuição e Logística 4PL A QualiThings pode auxiliar empresas brasileiras e estrangeiras criando estratégias de distribuição por meio de centros logísticos especializados em produtos para saúde. Boas Práticas (BPF e BPDA) As Boas Práticas de Fabricação (BPF) e as Boas Práticas de Distribuição e/ou Armazenagem (BPDA) são procedimentos exigidos pela Anvisa para garantir padrões mínimos de qualidade dos produtos para a saúde e se aplicam a todas as empresas de dispositivos médicos. Planejamento Tributário & Contas a Receber Nossos profissionais são treinados para analisar, planejar e desenvolver estratégias considerando o que é benéfico para seus parceiros e em conformidade com a legislação. Vigilância Pós-Mercado & Estratégias Nossos serviços pós-registro envolvem a avaliação de requisitos e a sugestão de informações para os processos de negócios, projetados para garantir a satisfação do cliente e a conformidade do produto. Regularização de Empresas e de Produtos Podemos auxiliar na obtenção de AFE e de licenças sanitárias, na elaboração de respostas a notificações e a não conformidades, e nas ações de tecnovigilância. Saiba mais Why Brazil? A continuously expanding healthcare sector with great purchasing power - Brazil represents a significant market opportunity for medical device manufacturers. Find out why you should consider selling your medical devices in Brazil and how. Learn More Contato BRASIL - RS - PORTO ALEGRE Rua Luiz Voelcker, 835, Porto Alegre, RS 91330-190 +55 (51) 3937-8827 patricia.huber@qualithings.com EUA - FL - MIAMI 1150 NW 72nd Ave #455, Miami, FL 33126, EUA +1 (689) 233-9730 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp Subscription Form Join Thanks for subscribing!

PERGUNTAS FREQUENTES Estamos aqui para ajudar. O que devo saber antes de exportar para o Brasil? Brazil represents one of the most popular destinations for medical device manufacturers, being the largest healthcare market in Latin America. But Brazil has a complex set of regulations that challenge foreign manufacturers. Anvisa (the Brazilian Health Regulatory Agency) carries out all registration and inspection processes, meaning that only companies based in Brazil can apply for registration. Companies based elsewhere that do not have subsidiaries in Brazil must instead rely on third-party companies legally constituted in the country, such as QualiThings, who will be legally responsible for the products commercialized in the Brazilian territory. It is recommended that foreign companies have local technical staff for customer support. Moreover, exporting regulated medical devices to Brazil might include the need for specific pre-market authorizations issued by Anvisa and other regulatory bodies. So, the commercialization of health products in Brazil relies on Anvisa’s approval. Most medical devices must be registered by Anvisa and the manufacturer might have to be certified by this Agency for Good Manufacturing Practices, a process which might include audits at the place of origin. Additionally, products regulated by Anvisa are subjected to approval at borders when entering Brazil and might be subjected to physical inspection. Como posso saber se preciso de uma autorização de pré-comercialização para vender meu produto no Brasil? Brazil is the largest medical device market in Latin America and has a well-established but complex regulatory system. Before the medical devices can be marketed in Brazil, they must comply with Anvisa’s requirements, which vary significantly depending on the product’s risk class. As such, the correct classification of the medical device is crucial. Our company has the knowledge and expertise to work out the proper classification for your medical device and to assist with every step of the preparation and submission of your application. Qual é a diferença entre "notificação" e "registro"? Notification (“Notificação”): Anvisa’s authorization for risk class I and II devices is achieved through a simplified process. A technical dossier of the product, and the proposed label and instructions for use in Portuguese, must be submitted to Anvisa. Class I and II notifications do not expire but must be reviewed periodically. Registration (“Registro”): Risk class III and IV medical devices must take a regulatory route which requires BGMP certification prior to product’s authorization. This includes submitting to Anvisa a complete technical file containing clinical data, biocompatibility studies, performance tests, etc. Class III and IV registrations are valid for ten years. *Please note that additional certifications issued by other regulatory bodies (INMETRO, ANATEL) might be needed depending on the device’s features. Qual é a diferença entre "notificação" e "registro"? Yes! You can! Brazilian Resolution RDC 102/2016 allows great flexibility for registration transfers. However, transfers will require the cooperation of the previous BRH: they must sign the transfer contract and ask Anvisa to cancel the registration under their name. Anvisa will issue a new registration number once the transfer is approved, but the registration will carry the original expiry date.

Market Authorization: Registering a Medical Device Risk Classification Before the medical devices can be marketed in Brazil, they must comply with Anvisa’s requirements , which vary significantly depending on the product’s risk class. Therefore, the first step is to determine the medical device classification . In Brazil, in accordance with RDC 751/2022, chapter II, medical devices are divided into four classes, based on their risk (Classes I, II, III and IV, from very low to very high risk ). The market authorizations are issued by Anvisa depending on the product's risk class : Notificação (Notification) or Registro (Registration). Notificação is an abbreviated registration process and applies to class I and II medical devices. For class III to IV medical devices there is a more complex registration process, with more documents, GMP certification and often other certifications required. Very similar to Annex VIII Classification rules of MDR in Europe, there are 22 classification rules determined by RDC 751/2022. Brazilian risk classes I and IV can be equivalently seen as European classes I and III, and Brazilian risk classes II and III correspond to European classes IIa and IIb, roughly. How we can help How we can help How we can help How we can help Product Categorization We will confirm whether your product is categorized as a medical device, cosmetic, drug, food, or combination product. Product Risk Classification We will ensure proper risk classification in accordance with RDC 751/2022 and through comparison with similar products before beginning the registration process. ...and much more! Check out our full business scope Get more information Fale com a equipe para saber mais. Falar com a equipe Falar pelo WhatsApp

Barriers and Challenges How difficult is it to enter the Brazilian market? Brazil can be a challenging market for doing business, partly due to a complicated regulatory environment. There are many difficulties faced by those companies that want to export to Brazil and to Brazilian companies that want to import. Foreign companies often report duplicated, arbitrary, and sometimes discriminatory regulations as barriers in Brazil. Other major hurdles to doing business in Brazil include high tariffs, local content requirements, uncertain customs system, and high and unpredictable tax burdens. 01 Excessive bureaucracy Exporters in highly regulated industries such as medical devices have a particularly challenging time navigating Brazilian rules and regulations. The pharmaceutical and medical device sectors face a complex and difficult patent system, excessive bureaucracy, and strict price controls. Foreign companies can increase their chances of success by working with Brazilian partners and demonstrating their commitment to the Brazilian market. Moreover, it is mandatory to have a local importer or distributor for product liability. 02 Customs clearance The entry of imported medical devices to Brazil is another challenge, since it is subject to permission issued by the Brazilian authorities that regulate the entry and commercialization of these goods. Goods that require an import license need approval from up to 16 authorities. In certain cases, these licenses can be obtained after the shipment of goods, but always prior to customs clearance. 03 Complex regulatory system In Brazil, all health-related products – including medical devices – are regulated by the National Health Regulatory Agency (ANVISA), the Brazilian equivalent to the FDA. ANVISA issues the mandatory regulations to which medical device companies and products must comply to. All products must be registered or notified to obtain a sales license. For products with a higher-grade risk or considered strategic for the public system, it may be necessary to have additional local certifications and inspections in manufacturing plants. For example, electromedical devices must additionally be certified by the National Institute of Metrology Standardization and Industrial Quality (INMETRO) before obtaining ANVISA approval. For medical devices with radio frequency spectrum or wireless communication it is also necessary to be certified by the National Telecommunications Agency (ANATEL). 04 Complex import system Brazil’s import system is very complex and can add as much as 100% of the value of the product when factoring in freight, tariffs and taxes. Import tariffs for medical products vary from 0 to 18%. 05 Lenghty approvals The products that enter Brazil are subject to approval at the borders and can be subjected to physical inspection. However, since 2010, only ANVISA Officers can validate and approve the entry of health products in Brazil. The problem is that ANVISA has a very limited number of Officers, which can cause delays when the importation orders are higher than the number of Officers. 06 Local barriers Barriers exist for Brazilian companies, too. When importing medical devices into Brazil, certain documents are required. For example, one of the mandatory documents is the operating permit issued by ANVISA (also known as AFE, or Autorização de Funcionamento de Empresa), and to obtain this document the company and the technical manager need to be registered, pay fees, and be approved by ANVISA. Brazil in general is known as a difficult export market, with a lot of bureaucracy, lots of paperwork (especially for the importer) and high final prices. But opportunities are there . Do you see the potential and want to join the Brazilian market, but worry about the bureaucracy? Do you want to sell your products in Brazil but don’t know where to start? We are here to help! QualiThings is your one-stop shop for everything you need to enter the Brazilian market of medical devices. Get in Touch +55 (51) 3937-8827 info@qualithings.com Falar com a equipe Falar pelo WhatsApp

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