Search Results

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 Nome Sobrenome Email Mensagem Obrigada pela mensagem! Enviar Subscription Form Join Thanks for subscribing!

Address R. Luiz Voelcker, n. 835, sala 5, Bairro Três Figueiras, Porto Alegre / RS - Brazil Phone +55 (11) 2050-2252 +55 (51) 3937-8827 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 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

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.

Why Brazil? Here's why you should consider selling your medical devices in Brazil Brazil in Numbers Brazil is the 7th largest populated country in the world, with an estimated population of 215 million inhabitants and a total area of 8.515.767 km². The country has the 9th largest GDP in the world and is considered an advanced emerging economy . It has the largest healthcare market in Latin America and the 2nd largest in the Americas. According to the World Bank, in 2021 private and public healthcare expenses in Brazil comprised over 9% of its GDP, which represents US$ 161 billion . Brazil has a Unified Healthcare System (Sistema Único de Saúde, SUS ), which provides free access to medical services to all Brazilian citizens. The public health system is the sole provider of health services to approximately 72% of the population, and it is estimated that over 50 million Brazilians have access to the private healthcare system as well. There are over 420,000 registered health establishments in the country, including over 7,300 hospitals, 62% of which are privately-owned, according to the Brazilian Federation of Hospitals and the National Health Confederation. As of 2022, there were 427,097 hospital beds, 710 health insurance providers, and 546,000 physicians. From January to December 2023, there was a total of over 13 million hospitalizations (about 5.6% higher than in the same period of 2022) and over 5 million surgeries (10.2% higher). The volume of purchases by SUS – which had decreased during the pandemic – reached its highest levels ever in 2023. There was a 13% increase in total spending on medical devices in comparison with the previous year. The projected revenue for this market is expected to reach US$ 10.42 billion in 2024 with an annual growth rate of 7% , resulting in a market volume of US$ 14.65 billion by 2029 . The Scenario for Medical Devices There are over 100,000 medical devices with valid market authorizations (“registro ” or “notificação ”) issued by Anvisa, of which approximately 75% are manufactured abroad . This means that a significant portion of health products are imported , due to various characteristics of the Brazilian market and the products themselves. Therefore, importers play an important role by offering more options to patients and health service providers. Most of the medical devices produced in Brazil are not manufactured by national companies, but by large multinationals that have set up a manufacturing plant in the country. However, these companies will usually sell their products at a higher price, in order to compensate for their investment. In this scenario, imported products are a reasonable, affordable option – and sometimes the only option available. Despite the recent economic downturn, private and public hospitals still have great purchasing power, and with continued expansion of Brazil’s private health care sector, the market is expected to grow. The nods in the direction of the revision of SUS reimbursement tables, the reactivation of some health programs, and structural measures such as the Tax Reform, represent a positive counterpoint to the challenging scenario. 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. I want to learn more about the Brazilian market, Help me! First Name Last Name Email Message Submit Thank you for your message! Our specialists will contact you shorlty.

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.

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 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 Sign up to receive additional details. First Name Last Name Email Subscribe Thanks for submitting!

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.

Packages We at QualiThings offer highly specialized, high-quality, customized solutions, tailored to each client’s needs. Since we work with customized solutions, our services are modulable : you can pick and choose the services you are interested in, and we will prepare a package (or “bundle”) that suits you the most. You pay only for what you really need! Get a Free Quote ... or ... Choose a Package No strings attached! Learn the benefits Get a Free Quote Fill in the information and pick which services you are looking for. You will receive a free quotation soon - No strings attached! First Name Last Name Email Send Thanks for submitting! One of our specialists will contact you shortly.

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.

Our Services When it comes to doing business in or with Brazil, we offer integrated solutions that are tailored to meet your specific needs . From product regularization to tax planning, from accounting to trading services, our team and partners can handle every step required to turn your ideas into reality. Hosting services Run economic evaluation studies to check if the target price for the product is feasible and acceptable by the market Product registration and regularization Remote and on-site audits Review products labeling and adjust them to Anvisa’s requirements Technovigilance and adverse event reporting Develop strategies for customs and tax exemptions Strategically handle Anvisa’s queries and prepare responses Remote consultancy Work as an Authorized Representative for foreign companies Interact with Anvisa on your company’s behalf Gap analysis Issue audit report with suggested corrective and preventive actions (CAPA) Post-market surveillance Nationalization of medical devices Warehousing and inventory management Prospect and qualify new distributors and clients Technical consultancy Act as the Brazilian Registration Holder (BRH) Interpreting regulations and developing regulatory documentation Review of the QMS to ensure compliance with Anvisa’s requirements Accompany the Anvisa audit Update product registration files Support for import processes Optimize product distribution and merchandising Bring your products closer to the best national distributors Regularization of companies Evaluate product’s marketability through partnerships with hospitals Evaluate medical device classification and grouping Prepare the manufacturer for Anvisa inspection (pre-inspection or mock audit) Translate technical documents Renew product certificates and market authorizations Customs clearance Technical and legal assistance to stakeholders Assist with registration transfer requests Training Through our network of partners, we offer a range of additional services, such as market research, quality certifications, consularization of documents, headhunting, among others. Contact us Book a meeting Learn more 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.

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.