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 info@qualithings.com Falar com a equipe Falar pelo WhatsApp

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.

Why Brazil? Here's why you should consider selling your medical devices in Brazil Brazil in Numbers Population : Approximately 212 million people , making Brazil the 7th most populous country in the world. Economy : The largest economy in Latin America and among the world's 10 largest economies by GDP. Healthcare Market : The largest healthcare market in Latin America and one of the largest globally, with healthcare expenditure representing around 10% of GDP . Universal Healthcare : 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, while over 50 million people also have private health insurance. Healthcare Infrastructure : More than 420,000 healthcare establishments , including over 7,000 hospitals , supported by approximately 575,000 physicians nationwide. Medical Device Market : Brazil is the largest medical device market in Latin America, with continued growth expected through 2030 , driven by increasing healthcare investments, an aging population, and expanding access to medical technologies. The projected revenue for this market is expected to continue growing at a strong annual rate through 2030, maintaining its position as the largest market in Latin America , driven by an aging population, increasing healthcare investments, and rising demand for advanced medical technologies. 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 Falar com a equipe Falar pelo WhatsApp

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 Falar com a equipe Falar pelo WhatsApp

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.

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 Falar com a equipe Falar pelo WhatsApp

Tax Planning & Accounts Receivable Management Operating in Brazil offers an additional challenge related to tax planning for foreigner companies. The laws and regulations are complex and difficult to understand. QualiThings have professionals trained to analyze, plan, and develop strategies considering what is beneficial for its partners and in compliance with the Brazilian legislations. Moreover, we can manage the manufacturers’ accounts receivable by creating specific procedures according to the size and needs of each client. Our company will exchange files with banks, and register, reconcile, and write off paid bills, as well as solve operational and logistical problems that may affect foreign partner in Brazil. How we can help How we can help How we can help How we can help Tax Planning We will analyze, plan, and develop strategies considering what is beneficial for your company and in compliance with the Brazilian legislation. Accounts Receivable Management We can manage the manufacturers’ accounts receivable by creating specific procedures according toyour needs. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

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 Falar com a equipe Falar pelo WhatsApp

FALE COM NOSSOS ESPECIALISTAS Agende uma conversa gratuita sobre sua estratégia regulatória e de entrada no mercado. Nome Sobrenome E-mail Empresa Mensagem Enviar Agradecemos sua mensagem! Um de nossos especialistas entrará em contato em breve. Vamos levar seus dispositivos médicos ao Brasil. Endereço R. Luiz Voelcker, n. 835, sala 5, Bairro Três Figueiras, Porto Alegre / RS - Brazil Telefone +55 (51) 3937-8827 +55 (11) 2050-2252 E-mail patricia.huber@qualithings.com Conecte-se HORÁRIO DE ATENDIMENTO Segunda a Sexta-Feira: 9h00 - 18h00 Sábado/Domingo: FECHADO

CONHEÇA NOSSOS CLIENTES Presente e passado O(A) Qualithings tem orgulho de servir clientes da região de São Paulo . Temos a necessidade de estrutura para fornecer as soluções que você precisa e o suporte para tornar seus objetivos realidade. Vamos sempre além para encontrar formas inovadoras de resolver desafios existentes e futuros. Entre em contato se quiser fazer parte da nossa lista de clientes satisfeitos. HERA Desde um pequeno negócio Depois de muitos anos no mercado, este cliente pediu nossa ajuda no processo de transição para um novo segmento. Desde nossas primeiras conversas até hoje, nossa parceria fez sucesso em um novo mercado. MACHADOS Um novo começo O(A) Qualithings trabalhou com este cliente desde o início e estamos muito felizes com a parceria criada durante esta jornada. Juntos alcançamos resultados notáveis e temos sido um prazer com o crescimento de seus negócios. VOLVA Dados do Parceiro(a) de longa Este cliente nos contatou para consultar como fazer a transição de uma pequena empresa local para um negócio regional maior. Nossa colaboração tem sido realmente notável e estamos felizes por ver esse negócio prosperar como líder em seu ramo. NOSSAS AVALIAÇÕES Acreditamos que ações valem mais do que palavras Este é um espaço para depoimentos. Use este espaço para compartilhar avaliações sobre você, seus serviços ou o seu negócio. Faça seus visitantes tomarem a iniciativa de falar com você! S. Bonifácio Este é um espaço para depoimentos. Use este espaço para compartilhar avaliações sobre você, seus serviços ou o seu negócio. Faça seus visitantes tomarem a iniciativa de falar com você! C.Davi Este é um espaço para depoimentos. Use este espaço para compartilhar avaliações sobre você, seus serviços ou o seu negócio. Faça seus visitantes tomarem a iniciativa de falar com você! R.Torres

BGPM Certification BGMP (Brazilian Good Manufacturing Practices ) is a set of mandatory procedures created by Anvisa to ensure minimum quality standards in the manufacturing, storage, transportation, and distribution processes of health products. The main objective is to ensure that all products are safe, effective, and of high quality. BGMP apply to all companies that manufacture medical devices, located either on national territory or abroad. Manufacturers of Class III and IV medical devices must be certified in compliance with BGMP requirements before they can register their products in Brazil. How to Obtain On-site Audit Review of the QMS MDSAP Note BGMP Certification can be obtained t hrough: Anvisa’s on-site audit Review of the QMS documentation Analysis of the MDSAP (Medical Device Single Audit Program) audit report Please note that MDSAP certificate can facilitate obtaining BGMP Certification, but it doesn’t mean that a MDSAP certificate will automatically grant a BGMP Certification! MDSAP certification is only a good reference to accelerate BGMP certification, however it does not replace it. MDSAP is based on ISO 13485 and is a way that medical device manufacturers can be audited once for compliance with the standards and regulatory requirements of up to five different markets: Brazil, Australia, Canada, Japan, and United States. Undergoing an MDSAP audit may accelerate the process for BGMP certification, since Anvisa may use the MDSAP report in lieu of a premarket audit. Anvisa's on-site audit is very similar to ISO 13485 audits Slowest route Least expensive option Certificate is valid for 2 year Anvisa may choose to perform a remote audit instead If the Quality Management System documentation is sufficient, Anvisa may grant BGMP certification without the need of an audit. Faster route Least expensive option Certificate is valid for 2 year The BGMP certificate is valid for 2 to 4 years , depending on the route. After the first years of GMP Certification, the manufacturer should provide a self-inspection report. After an assessment based on documental analysis (audit report within the scope of ISO 13485 or MDSAP), ANVISA usually renews the GMP certification without the need of a re-inspection. How we can help How we can help How we can help How we can help Adherence to GMP We can help manufacturers adhere to the Brazilian Good Manufacturing Practices through our consulting services. Evaluation of the QMS Our Quality Assurance experts will analyze your company’s QMS documentation to ensure compliance with Anvisa’s requirements, according to ISO 13485 and RDC 665. Mock Inspection We can perform a remote or on-site “mock inspection” (pre-audit), which is recommended for proper gap analysis and to ensure the manufacturer complies with BGMP requirements – so you have time to correct any points before the actual Anvisa inspection. Inspection Report We will issue an audit report outlining any nonconformities found and suggest corrective and preventive actions (CAPA) to avoid potential audit findings and penalties. Accompany the Inspection Our team of experts and trained auditors are available to accompany the Anvisa inspection and help bridge the language barrier to overcome any misunderstandings. File BGMP Petition to Anvisa We will fill out all necessary forms, gather the proper documents, adjust them to fit the required norms, and submit the file for Anvisa’s approval. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Falar com a equipe Falar pelo WhatsApp

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

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 Falar com a equipe Falar pelo WhatsApp

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 Falar com a equipe Falar pelo WhatsApp

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 info@qualithings.com Falar com a equipe Falar pelo WhatsApp