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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! 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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.

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.

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.

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.

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

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.

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.

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 contato@qualithings.com First Name Last Name Email Message Send Thanks for your message!

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.

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We Are Coming SOON Who We Are This is your About section. This space is a great opportunity to give a full background on who you are, what you do and what your site has to offer. Your users are genuinely interested in learning more about you, so don’t be afraid to share personal anecdotes to create a more friendly quality. Double click on the text box to start editing your content and make sure to add all the relevant details you want site visitors to know. If you’re a business, talk about how you started and share your professional journey. Explain your core values, your commitment to customers and how you stand out from the crowd. Add a photo, gallery or video for even more engagement. Get on the List Sign up to receive the first word when we go live. First Name Last Name Email Subscribe Thanks for submitting!

We Are Coming SOON Who We Are This is your About section. This space is a great opportunity to give a full background on who you are, what you do and what your site has to offer. Your users are genuinely interested in learning more about you, so don’t be afraid to share personal anecdotes to create a more friendly quality. Double click on the text box to start editing your content and make sure to add all the relevant details you want site visitors to know. If you’re a business, talk about how you started and share your professional journey. Explain your core values, your commitment to customers and how you stand out from the crowd. Add a photo, gallery or video for even more engagement. Get on the List Sign up to receive the first word when we go live. First Name Last Name Email Subscribe Thanks for submitting!

We Are Coming SOON Who We Are This is your About section. This space is a great opportunity to give a full background on who you are, what you do and what your site has to offer. Your users are genuinely interested in learning more about you, so don’t be afraid to share personal anecdotes to create a more friendly quality. Double click on the text box to start editing your content and make sure to add all the relevant details you want site visitors to know. If you’re a business, talk about how you started and share your professional journey. Explain your core values, your commitment to customers and how you stand out from the crowd. Add a photo, gallery or video for even more engagement. Get on the List Sign up to receive the first word when we go live. First Name Last Name Email Subscribe Thanks for submitting!

We Are Coming SOON Who We Are This is your About section. This space is a great opportunity to give a full background on who you are, what you do and what your site has to offer. Your users are genuinely interested in learning more about you, so don’t be afraid to share personal anecdotes to create a more friendly quality. Double click on the text box to start editing your content and make sure to add all the relevant details you want site visitors to know. If you’re a business, talk about how you started and share your professional journey. Explain your core values, your commitment to customers and how you stand out from the crowd. Add a photo, gallery or video for even more engagement. Get on the List Sign up to receive the first word when we go live. First Name Last Name Email Subscribe Thanks for submitting!