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Marketing & Sales After the medical device is approved for commercialization by Anvisa, selling the product might pose another challenge . In Brazil, the healthcare market is price-driven, with products that are manufactured in-country having a distinct price advantage. The Government of Brazil, which is the sponsor of several hospitals, is the main buyer of healthcare products to supply the Brazilian public healthcare system (SUS ), which is the largest of its kind in the world. Foreign companies can participate in bids, as long as they have a Local Representative . QualiThings has an active database containing the main medical device suppliers, importers, distributors, and clients in Brazil, including over 6,000 public and private hospitals. This system keeps market information updated in real-time. Moreover, our sales services are connected to the public procurement systems in Brazil, allowing foreign companies to access bids throughout the Brazilian territory. Our company also has access to private procurement systems that include opportunities in large hospitals with high demand for health products. Post-Market Surveillance & Customer Satisfaction Assurance Whether you are a small or a large-scale manufacturer, your business expansion , continual improvements , and customer satisfaction rests mainly on the quality standards of your business. Our post-registration services involve evaluating your requirements and suggesting inputs to the business processes that are designed to assure customer satisfaction as well as compliance. How we can help How we can help How we can help How we can help Connect with Clients We offer access to our active database of potential clients, so your company can enter the Brazilian medical device market more quickly. Marketing & Sales Our sales team will focus on lead generation, brand building, and customer engagement, as well as closing deals and generating revenue for your company. Participate in Bids We can work as an Authorized Representative for foreign companies wishing to participate in bids. Customer Satisfaction We will evaluate customer feedback and suggest inputs to the business processes to assure customer satisfaction and compliance. ...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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Technovigilance & Adverse Event Reporting Technovigilance Complying with Brazil's medical device adverse event reporting requirements is of outmost importance if you want to maintain your product in the market . Brazil’s National Health Surveillance Agency (ANVISA) requires medical device manufacturers selling in the country to comply with a technovigilance system for post-market monitoring and field safety corrective actions . Resolutions RDC No. 67/2009 and RDC No. 551/2021 provide critical information on terminology, timelines, and other technovigilance reporting requirements in Brazil. Companies that fail to accurately report incidents could face severe penalties . Unawareness is not an acceptable excuse for not reporting incidents, so manufacturers must be proactive. As the device manufacturer, you and your Brazilian Registration Holder (BRH) are equally responsible for reporting adverse events to ANVISA. An adverse event report (also known as "Notivisa ") must be submitted if a device malfunction or misuse results in death or serious injury , could lead to death or to serious injury if it were to recur, or in other applicable circumstances, as described in the regulation. A technical complaint must also be reported under certain circumstances if a reoccurrence could lead to a severe adverse event. Manufacturers must notify ANVISA if a field safety action or recall is necessary to reduce the risk of death or serious injury. An alert must also be reported to ANVISA and distributed to consumers detailing the necessary corrective action. To report an adverse event to ANVISA, you must first inform your BRH that a reportable adverse event has occurred and if a field action is necessary, obeying the applicable timeline depending on the nature of the event. How we can help How we can help How we can help How we can help Submit Adverse Event Reports and Recalls If we act as your Registration Holder, our team in Brazil can submit adverse event reports and recall information to ANVISA on your behalf. Receive and Evaluate Incident Reports Our experienced consultants can help determine when incidents are reportable and ensure that final incident reports are submitted to ANVISA on time. Post-Market Surveillance We have experience assisting numerous manufacturers with post-market surveillance and notifying ANVISA in compliance with the applicable timeline depending on the nature of the event. Organize Recalls and Other Field Actions We can issue an alert message to consumers when a field safety action is needed, submit monitoring reports and final adverse event reports to ANVISA, coordinate product withdrawal, reverse logistics and rework, when necessary. ...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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Regulatory Strategies The Brazilian legislation establishes that only national companies can register medical devices in Brazil , and these companies must have local and federal sanitary licenses. Foreign companies that wish to sell their products in Brazil must establish a local Brazilian manufacturing unit or a local office. Another option is to appoint a partner company legally constituted in Brazil , such as Qualithings , that will be the holder of the authorization issued by Anvisa (the Brazilian Registration Holder, or BRH) and legally responsible for the products imported to and distributed in the Brazilian territory. In other words, foreign manufacturers must have a Brazilian agent who has a business license in Brazil and will communicate with Anvisa in Portuguese on your behalf. The BRH will be responsible for maintaining the registration during its lifetime. Product Registration Options If you choose an Authorized Representative or Hosting Services to be your BRH: Authorized Representative To simplify sales activities of medical devices in Brazil, an excellent solution is appointing an authorized representative. An authorized representative is usually an importer that has solid knowledge of its area of expertise and extensive market share. In most cases, they are large companies with a complete structure dedicated to international business. These companies will usually bear all the expenses from product registration to customs fees, with a counterpart: have exclusive rights over the product in Brazil. The main advantage is having sound experience and rapidly enter the market, without the need to establish a subsidiary in Brazil and get all the licenses required by Anvisa. Hosting Services To simplify the registration process, an option is to hire hosting services. With hosting services, product registration will be issued on behalf of a third consulting party that owns and hosts the registration and provides an import authorization for any distributors designated by the manufacturer. In this case, the consulting party will only act as the BRH and will not perform any marketing, distribution, or sales activities. This option gives more flexibility and control of the manufacturer over the product than appointing an importer for that role. And there’s no need to choose an importer or distributor beforehand. It also reduces time and costs without binding to one agent. The "QualiThings" Advantage: We take the best out of both options and bring them to your company! QualiThings is licensed to act as your BRH – and more! Where most Brazilian Registration Holders focus only on the registration processes and others only on sales, QualiThings works with Regulatory Affairs , Quality Assurance and all aspects related to nationalization , distribution , and commercialization of medical devices. We are a consulting company and work as a boutique office with modular services , which means that we leave our clients free to make their own decisions and pick-and-choose which services they want to hire. This way, our clients know exactly what they are paying for and, overall, it turns out cheaper for them. Learn More The 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 and technical documents. Once your product is registered in Brazil, you can choose if you want to work with your own distributors or if you want to use our network. If you decide to use your own distributors and they cannot import products into Brazil, you can choose to hire your own importation partner or you can hire QualiThings . Learn More Choosing a... Representative ... as your BRH: Pros: L arge companies with solid knowledge and extensive market share Minimal short-term investment required Customer service Sound market experience Cons: Exclusive rights (the manufacture can sell the products only to the authorized representative) The BRH “owns” the product registration Choosing... Hosting Services ... as your BRH: Pros: More flexibility and control over the product and the registration No binding to one agent – the manufacturer can choose the distributor(s) Sound Regulatory Affairs experience Cons: More investment Lesser control of the market Distributors are usually small companies with little knowledge of the market The BRH is a third-party with no knowledge of the market Services provided are limited to regulatory affairs Choosing... QUALITHINGS ... as your BRH: Pros: Sound experience in Regulatory Affairs, Quality Assurance, import, distribution, and related areas of the Brazilian market for medical devices Overall reduced costs Flexibility No binding to one agent Extensive network of specialized experts Modular services (you pay only for what you really need), no hidden costs Customer service Less bureaucracy - There's no need to establish a subsidiary or get all the licenses required to sell in Brazil Cons: We can't think of any! 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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Nossos Serviços Autorização de Mercado: Registro de Dispositivos Médicos O primeiro passo é determinar a classificação do dispositivo médico. No Brasil, os dispositivos são divididos em quatro classes, com base no seu risco (Classes I a IV, de risco muito baixo a muito alto) e as autorizações de comercialização são emitidas pela Anvisa dependendo da classe de risco. A QualiThings realizará as análises para garantir a correta classificação dos produtos com base nas normas brasileiras. Após, nossa equipe se dedicará a adequar a documentação do produto, conforme exigência da Anvisa. elaborar o dossiê técnico do produto, que deverá incluir ficha técnica completa contendo dados clínicos, estudos de biocompatibilidade, testes de desempenho, etc. Agende uma reunião Book a meeting Boas Práticas de Fabricação, Armazenamento e Distribuição As Boas Práticas são um conjunto de procedimentos obrigatórios criados pela Anvisa para garantir padrões mínimos de qualidade na fabricação, armazenamento, transporte e distribuição de produtos para a saúde. O principal objetivo é garantir que todos os produtos sejam seguros, eficazes e de alta qualidade. As Boas Práticas aplicam-se a todas as empresas de dispositivos médicos localizadas em território nacional ou no estrangeiro. Os fabricantes de dispositivos médicos Classe III e IV devem ser certificados em conformidade com os requisitos das BPFs antes de poderem registrar seus produtos no Brasil. A QualiThings pode ajudar as empresas a aderir às Boas Práticas brasileiras por meio de seus serviços de consultoria. Agende uma reunião Book a meeting Marketing & Vendas Depois que o dispositivo médico for aprovado para comercialização pela Anvisa, a venda do produto pode representar outro desafio. No Brasil, o mercado de saúde é orientado pelos preços. O Governo brasileiro, patrocinador de vários hospitais, é o principal comprador de produtos de saúde para abastecer o Sistema Público de Saúde brasileiro (SUS), o maior do gênero no mundo, através de licitações. A QualiThings possui um banco de dados ativo contendo os principais stakeholders de dispositivos médicos no Brasil, incluindo mais de 6.000 hospitais públicos e privados. Nossos serviços de vendas estão conectados aos sistemas de compras públicas e privadas do Brasil, abrangendo licitações em todo o território brasileiro, inclusive em grandes hospitais com alta demanda por produtos para saúde. Marque uma reunião Book a meeting Âncora 1 Âncora 2 Âncora 3 Vigilância Pós-Mercado & Estratégias Quer você seja um fabricante de pequeno ou de grande porte, a expansão de seus negócios, as melhorias contínuas e a satisfação do cliente dependem principalmente dos padrões de qualidade de seu negócio. 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 dos produtos. Agende uma reunião Book a meeting Âncora 4 Distribuição, Armazenamento e Logística 4PL A QualiThings pode auxiliar empresas nacionais e estrangeiras criando estratégias de distribuição por meio de centros de distribuição especializados em produtos para saúde. Nossa empresa possui inúmeros parceiros em todo o Brasil, o que nos permite garantir que os produtos sejam entregues em suas localidades em condições adequadas e no prazo. Temos a capacidade de reduzir os prazos de entrega e, ao mesmo tempo, beneficiar os clientes. Marque uma reunião Book a meeting Âncora 5 Planejamento Tributário e Gestão de Contas a Receber Operar no Brasil oferece um desafio adicional relacionado ao planejamento tributário. As leis e regulamentos são complexos e difíceis de entender. A QualiThings conta com profissionais capacitados para analisar, planejar e desenvolver estratégias considerando o que é benéfico para seus parceiros e em conformidade com as legislações brasileiras. Além disso, podemos gerenciar o contas a receber criando procedimentos específicos de acordo com o porte e necessidade de cada cliente. Nossa empresa irá trocar arquivos com bancos, registrar, conciliar e dar baixa de contas pagas, bem como resolver problemas operacionais e logísticos que possam afetar nossos parceiros. Agende uma reunião Book a meeting Âncora 7 Hospedagem de Registros e da Conformidade dos Produtos Os certificados de registro de produto são válidos por 10 anos e o pedido de renovação deve ser apresentado em tempo hábil. Quaisquer alterações pós-aprovação realizadas nos dispositivos médicos deverão ser encaminhadas à Anvisa, com os documentos pertinentes de acordo com as exigências vigentes. Como parte de nossa rotina diária, a QualiThings acompanha todas as publicações oficiais, mantendo-se atualizada com as últimas novidades e alterações regulatórias. Podemos alertar oportunamente as empresas parceiras caso seja necessária alguma ação imediata para manter o registro do produto válido e evitar penalidades. Agende uma reunião Book a meeting Âncora 6 ... and much more! Check out our full business scope here Contact us Book a meeting Get a free quote 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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Market Analysis & Product Marketability Through market analysis , QualiThings can do a comprehensive study of a specific market, encompassing factors like market size, trends, and competitive landscape. Also, through product marketability studies, we can assess how well your products fit within the market, considering factors like consumer demand, pricing, and legal compliance. Market Analysis Market analysis involves a detailed assessment of a target market, including its size, trends, and competitive landscape. Purpose : We will help your business understand market dynamics, identify opportunities, and assess the viability of new products. Features : Market Size and Growth : Understand the overall size and potential for growth within the market. Customer Profile : Identify target customers, their needs, and preferences. Competitive Analysis : Analyze direct and indirect competitors, their strengths, and weaknesses. Market Analysis Product marketability refers to the extent to which a product is suitable for a particular market, considering factors like consumer demand, regulatory compliance, and competitive positioning. Purpose : We will help your business ensure that your products align with market needs and legal requirements, increasing the likelihood of success. Features : Consumer Demand : Assess whether there is sufficient demand for the product within the target market. Legal Compliance : Ensure the product meets all relevant legal and regulatory requirements in the target market. Competitive Differentiation : Identify unique selling points that will make the product stand out from competitors. Product Features : Determine whether the products’ features and benefits meet the needs and preferences of the target market. About These Services In essence, market analysis provides the broad context for a product, while product marketability focuses on how well that product fits within the market's specific landscape. Both analyses are pivotal if you want to be successful in the Brazilian market – regardless of experience – if you are just starting or expanding your business. QualiThings offers what no one else does : Our team of experts have decades of working knowledge as distributors, sellers, and end-users. Our combined experiences and expertise allow us to provide you with the most valuable insights into the Brazilian market. 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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Address R. Luiz Voelcker, n. 835, sala 5, Bairro Três Figueiras, Porto Alegre / RS - Brazil Phone +55 (11) 2050-2252 +55 (51) 3937-8726 Email contato@qualithings.com Connect ENTRE EM CONTATO COM NOSSOS ESPECIALISTAS Name Email Subject Message Enviar Agradecemos sua mensagem! Um de nossos especialistas entrará em contato em breve. HORÁRIO DE ATENDIMENTO Segunda a Sexta-Feira: 9h00 - 18h00 Sábado/Domingo: FECHADO

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 ROGÉRIO FILOMENA Especialista de Produto e Sócio-Fundador O Sr. Filomena é um dos nossos profissionais seniors e sabe bem o que faz um negócio ter sucesso. Com mais de 30 anos de experiência, a Sr. Filomena possui o conhecimento necessário para guiá-lo no caminho ao sucesso. PATRICIA HUBER Diretora de Qualidade e Sócia-Fundadora As habilidades excepcionais e a verdadeira paixão da Sra. Huber inspiraram um tremendo crescimento. Trabalhando com motivação e foco em resultados, nossa Especialista em Assuntos Regulatórios e Diretora de Qualidade ajudou a empresa a chegar onde está hoje. Agende uma reunião

Market Authorization: Registering a Medical Device Device Grouping Anvisa grants registration of individual products as well as of families , systems , and set/kits , based on the grouping of products, much like other major global markets. Differences in size, dimension, or shape, for example, generally do not matter. If you have multiple products that are similar, it is pivotal to determine the correct product family grouping , because this will determine the number of petitions (submissions) required to Anvisa. Grouping is crucial for regulatory strategy as it determines how devices can be authorized in a regulatory petition and can significantly reduce costs overall. The definition of family in RDC 751/2022 describes that products within a family must have similar technical characteristics in five areas: Indication and intended purposes Operation and mechanism of action Embedded technology Contents or composition Precautions, warnings, and special cautions Grouping is determined according to the following regulations, depending on the medical device category. In the case of materials, the initial step is to determine if the device is listed on the specific regulation (IN 101/2023). If not, grouping should be evaluated according to the general rules set by RDC 556/2021. Accessories in medical equipment require a separate registration only if one of the following conditions apply: the manufacturer is different; it is not an active accessory and is subject to authorization by Anvisa as a material, IVD, sanitizer, cosmetic, medical device etc; or it is a nonactive accessory with a higher risk class than the medical equipment itself. How we can help How we can help How we can help How we can help Device Grouping We will determine proper device grouping to simplify regulatory processes, using a wholesome approach – we also take into consideration the impacts that proper grouping will play on taxation, customs, importation, marketing etc. Grouping Evaluation We can evaluate and customize product grouping to reduce the overall costs. ...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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Import & Product Nationalization Brazilian importers are required to register with the Foreign Trade Secretariat (SECEX), a division of the Ministry of Development, Industry, Trade and Services (MDIC) through its Integrated System for Foreign Trade (Siscomex). The need for extra paperwork varies according to the item being imported. For instance, the Ministry of Health oversees all products that could impact human health, such as drugs, dietary supplements, beauty products, and medical devices. These products must be registered with the National Health Regulatory Agency (ANVISA), the Brazilian counterpart to the FDA. NCM In 1995, Brazil implemented the Mercosur Common Nomenclature (NCM ; “Nomenclatura Comum do Mercosul ”, in Portuguese), for tariff classification. The NCM code is an eight-digit number based on the Harmonized System (HS) used to identify the nature of goods for import/export. In order to import products into Brazil, businesses must comply with the customs system and inform the product’s NCM code on their legal documentation. Since the tariffs are charged according to the NCM , assigning the proper code to imported products is an essential part of doing business in Brazil, and it can directly impact the product’s final cost and marketability . Remember that your business can face non-compliance penalties , shipment delays , and seizure of products by authorities if your products are classified incorrectly. Import Tariffs Imports are subject to several taxes and fees in Brazil, which are usually paid during the customs clearance process. There are three taxes that account for the bulk of import costs: • Import Duty (II) II is a federally mandated product-specific tax charged on a Cost, Insurance, and Freight (CIF) basis for imported goods, and is assessed during the customs clearance process. • Industrialized Product Tax (IPI) IPI is a federal tax charged on most manufactured products. It is assessed at the point of customs clearance in the case of imports. As part of the federal government’s efforts to support local producers, IPI rates between imported and domestically produced goods within the same product category may differ. The IPI tax is a pass-along tax, assessed at each sale point, and thus not considered a cost for the importer, since the value is credited back to the importer, when sold to the end-user. The Government of Brazil levies the IPI rate by determining how essential the product may be for the Brazilian end-user. Generally, the IPI tax rate ranges from 0-15%. In the case of imports, the tax is charged on the product’s CIF value plus import duty. A product’s IPI rate is directly proportional to its import tariff rate. • Merchandise and Service Circulation Tax (ICMS) ICMS is a state government value-added tax applicable to both imports and domestic products. The ICMS tax on imports is assessed ad valorem on the CIF value, plus II, plus IPI. Although importers must pay the ICMS tax to clear the imported product through customs, it is not necessarily a cost item for the importer because the paid value represents a credit to the importer. When the product is sold to the end user, the importer debits the ICMS tax, which is included in the final price of the product and is paid by the end user. Effectively, the tax is paid only on the value-added; the tax is generally passed on to the buyer since it is included in the price charged for the merchandise. ICMS is charged on both intrastate and interstate transactions and is assessed on every transfer or movement of merchandise. The rate varies among states but in most cases is between 17-19 percent. On interstate movements, the tax will be assessed at the rate applicable to the destination state. Brazil’s customs regime allows for tariff-exempt imports of foreign manufactured goods under some circumstances. When there is no similar equipment being manufactured locally, an importer can seek an import duty waiver to reduce import costs. This tax reduction is called “ex-tariff” or “ex tarifário”. The ex-tariff regulation consists of a temporary reduction on import duties when there is no domestic equivalent production. To qualify, the manufacturers or their legal representatives must submit a technical application for review. It is advised to work with a local Brazilian company with experience in the program to determine if your product could be eligible. In addition to these taxes, several smaller taxes and fees apply to imports. Note that most taxes are calculated on a cumulative basis. Customs Regulations It's crucial to ensure all necessary customs paperwork is accurately and thoroughly completed. It's also important to work with a reliable and successful customs broker for the Brazilian market. Products frequently experience delays due to small mistakes or missing details in their paperwork. Items that are held can face significant charges, and Brazilian Customs often confiscate shipments that seem to have incorrect documents. Customs has the authority to impose fines and penalties as it sees fit. The Brazilian government has set up a digital system for tracking imports and streamlining customs clearance, called the Foreign Trade Integrated System (SISCOMEX ), which has lessened the paperwork needed for bringing goods into Brazil. Importers in Brazil are required to be listed in the SECEX Export and Import Registry and are given a password by Customs to access the SISCOMEX system. This system generates digital import documents and sends data to a central database. The system has been enhanced by the Foreign Trade Single Window (SW) Program, which is designed to centralize and enable the electronic submission of import and export documents. The Single Window program has cut down the time it takes to clear customs for maritime shipments to less than ten days, helping over 40,000 importers. How we can help How we can help How we can help How we can help NCM Evaluation We will determine the proper NCM tariff classification, keeping in mind the NCM code during the entire registration process, to get the most out of it. Stay Compliant We will check for updates to the NCM codes and legislation to avoid penalties, shipment delays, and seizure of products by authorities. Market Research We will provide feedback according to our market research to adapt and/or improve your product to fit the needs of the Brazilian users. Evaluate Product’s Marketability We have partnerships with hospitals to evaluate if the product’s characteristics are acceptable by the Brazilian market. Economic Feasibility Studies We can suggest selling price, comparing with other suppliers; run economic evaluation studies to check if the target price for the product is feasible and acceptable by the market Import & Customs Clearance We can provide support for import processes, from start to finish, in addition to defining strategies for tax and duty exemptions. ...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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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 Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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. Vantagens Os Diferenciais da QualiThings Soluções integradas : de serviços regulatórios e logísticos até assistência administrativa e jurídica, nossa rede de parceiros abrange tudo Serviços tipo boutique : soluções regulatórias personalizadas, altamente especializadas e de alta qualidade, exclusivas para as necessidades de sua empresa Tranquilidade : garantimos que todos os serviços prestados estão em total conformidade com as complexas regulamentações do mercado brasileiro Liberdade de escolha : sua empresa pode escolher entre utilizar nossa rede de parceiros ou escolher os seus próprios Menos burocracia : cuidamos da papelada para você Entrega pontual com o mais alto padrão de qualidade Equipe de especialistas com experiência prática Processos de negócios eficazes e compatíveis Reduza despesas , mitigue riscos e, o mais importante, concentre-se nas competências centrais do seu negócio Alcance mais clientes : Acesso rápido a potenciais fornecedores e clientes de longo prazo Obtenha insights sobre as especificidades do mercado brasileiro com custos operacionais reduzidos Obtenha insights sobre as especificidades do mercado brasileiro com custos operacionais reduzidos QualiThings is more than just a service provider; we are a strategic partner guiding businesses through the complexities of the Brazilian medical device market. With our knowledge , networks , and commitment , entering one of the globe's most dynamic markets is not only possible – it’s a smart way to growth. Nosso time Saiba mais sobre nossos especialistas A Qualithings tem orgulho de ter alguns dos melhores consultores em nossa equipe. Suas experiências, habilidades e paixão são essenciais para o sucesso do nosso negócio. ROGÉRIO FILOMENA Especialista de Produto e Sócio-Fundador O Sr. Filomena é um dos nossos profissionais seniors e sabe bem o que faz um negócio ter sucesso. Com mais de 30 anos de experiência, a Sr. Filomena possui o conhecimento necessário para guiá-lo no caminho ao sucesso. PATRICIA HUBER Diretora de Qualidade e Sócia-Fundadora As habilidades excepcionais e a verdadeira paixão da Sra. Huber inspiraram um tremendo crescimento. Trabalhando com motivação e foco em resultados, nossa Especialista em Assuntos Regulatórios e Diretora de Qualidade ajudou a empresa a chegar onde está hoje. Agende uma reunião

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 rodrigo@qualithings.com Nome Sobrenome Email Mensagem Obrigada pela mensagem! Enviar Subscription Form Join Thanks for subscribing!