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

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.

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.

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 Book a meeting First Name Last Name Email Message Send Thanks for your message! 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.

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.

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

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!

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!

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

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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!