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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!

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.

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!

Market Authorization: Registering a Medical Device Document Compilation - The Technical Dossier After defining the product’s grouping, risk class and type of registration (Notificação or Registro ), it is necessary to gather the mandatory technical documents and submit them to Anvisa for evaluation. The Technical File, also known as Technical Dossier or “Dossiê Técnico ”, is the regulatory bundle that presents the medical device characteristics, intended use, mechanism of action, potential risks, manufacturing processes and additional information. It shall include IFUs, labeling, packaging, clinical information, and the List of Essential Safety and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho ). This is in alignment with the International Medical Device Regulators Forum (IMDRF) guidance. The technical dossier must be structured and organized as described in RDC 751/2022 (Annex II) and according to the product's risk class . For those RA experts who are familiar with compilation of European MDR Technical Documentation Files or IMDRF-compliant documents, this should be a similar experience; however, knowledge on device grouping and other Brazilian legal requirements is paramount. Notification (“Notificação”) Anvisa’s authorization for risk class I and II devices is achieved through a simplified process. The product's technical dossier, proposed labeling, and instructions for use in Portuguese, must be submitted to Anvisa for analysis. Class I and II notifications do not expire but must be reviewed periodically, as they might be canceled upon request in case of reassessment, irregularities, or when fraud is observed. Registration (“Registro”) Risk class III and IV medical devices must take a regulatory route which requires BGMP certification prior to product’s authorization. This includes submitting to Anvisa a complete technical dossier containing clinical data, biocompatibility studies, performance tests, etc. Class III and IV registrations are valid for 10 years and may be renewed for equal and successive periods. After compilation of documents, the dossier (in Portuguese) must be submitted to Anvisa for approval . The submission of documents to Anvisa must be made in electronic format through Anvisa‘s Electronic Petitioning System. Our company has the knowledge and expertise to prepare the product’s technical dossier and to assist you with every step of the preparation and submission of your application – for all risk classes ! From the “easy” class I devices to the “more difficult” class IV high-risk electronic devices. We will also accompany the progress of the petition and act proactively for fast and reliable solutions. Responding to ANVISA's Requirements After document submission, Anvisa will evaluate if the product’s dossier is complete and if the medical device is proven to be effective and safe. If the Anvisa’s officers find the dossier incomplete or if any questions arise, they will issue a request called “exigencia ” (requirement upon incompleteness). The next obstacle is replying to Anvisa’s requests in a timely manner, which relies majorly on the legal manufacturer’s ability to provide the documents and answers as quickly as possible. With organized and strategic product registration, there is no doubt of successful approval in the end. Market Authorization When ANVISA is satisfied with the contents presented, they will approve the request and issue the market authorization (notification or registration) number for the device. This approval is published in the Official Federal Gazette (DOU). The market authorizations for class I and II medical devices don’t expire. The product certificate for class III and IV medical devices is valid for 10 years. How we can help How we can help How we can help How we can help Prepare Technical Dossier We will review the technical information, intended use, and claims for your device, ensuring proper classification and grouping before beginning the registration process. Direct Contact with Anvisa We will communicate with Anvisa on your behalf during and after the registration process as needed. Regulatory Strategy Our in-depth knowledge of the Brazilian medical device market allows us to provide the most efficient and cost-effective regulatory strategy for your devices. Monitor the Petition Our team will closely monitor the progress of your petition and take proactive steps to ensure fast and reliable solutions. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Import & Product Nationalization Brazilian importers are required to register with the Foreign Trade Secretariat (SECEX), a division of the Ministry of Development, Industry, Trade and Services (MDIC) through its Integrated System for Foreign Trade (Siscomex). The need for extra paperwork varies according to the item being imported. For instance, the Ministry of Health oversees all products that could impact human health, such as drugs, dietary supplements, beauty products, and medical devices. These products must be registered with the National Health Regulatory Agency (ANVISA), the Brazilian counterpart to the FDA. NCM In 1995, Brazil implemented the Mercosur Common Nomenclature (NCM ; “Nomenclatura Comum do Mercosul ”, in Portuguese), for tariff classification. The NCM code is an eight-digit number based on the Harmonized System (HS) used to identify the nature of goods for import/export. In order to import products into Brazil, businesses must comply with the customs system and inform the product’s NCM code on their legal documentation. Since the tariffs are charged according to the NCM , assigning the proper code to imported products is an essential part of doing business in Brazil, and it can directly impact the product’s final cost and marketability . Remember that your business can face non-compliance penalties , shipment delays , and seizure of products by authorities if your products are classified incorrectly. Import Tariffs Imports are subject to several taxes and fees in Brazil, which are usually paid during the customs clearance process. There are three taxes that account for the bulk of import costs: • Import Duty (II) II is a federally mandated product-specific tax charged on a Cost, Insurance, and Freight (CIF) basis for imported goods, and is assessed during the customs clearance process. • Industrialized Product Tax (IPI) IPI is a federal tax charged on most manufactured products. It is assessed at the point of customs clearance in the case of imports. As part of the federal government’s efforts to support local producers, IPI rates between imported and domestically produced goods within the same product category may differ. The IPI tax is a pass-along tax, assessed at each sale point, and thus not considered a cost for the importer, since the value is credited back to the importer, when sold to the end-user. The Government of Brazil levies the IPI rate by determining how essential the product may be for the Brazilian end-user. Generally, the IPI tax rate ranges from 0-15%. In the case of imports, the tax is charged on the product’s CIF value plus import duty. A product’s IPI rate is directly proportional to its import tariff rate. • Merchandise and Service Circulation Tax (ICMS) ICMS is a state government value-added tax applicable to both imports and domestic products. The ICMS tax on imports is assessed ad valorem on the CIF value, plus II, plus IPI. Although importers must pay the ICMS tax to clear the imported product through customs, it is not necessarily a cost item for the importer because the paid value represents a credit to the importer. When the product is sold to the end user, the importer debits the ICMS tax, which is included in the final price of the product and is paid by the end user. Effectively, the tax is paid only on the value-added; the tax is generally passed on to the buyer since it is included in the price charged for the merchandise. ICMS is charged on both intrastate and interstate transactions and is assessed on every transfer or movement of merchandise. The rate varies among states but in most cases is between 17-19 percent. On interstate movements, the tax will be assessed at the rate applicable to the destination state. Brazil’s customs regime allows for tariff-exempt imports of foreign manufactured goods under some circumstances. When there is no similar equipment being manufactured locally, an importer can seek an import duty waiver to reduce import costs. This tax reduction is called “ex-tariff” or “ex tarifário”. The ex-tariff regulation consists of a temporary reduction on import duties when there is no domestic equivalent production. To qualify, the manufacturers or their legal representatives must submit a technical application for review. It is advised to work with a local Brazilian company with experience in the program to determine if your product could be eligible. In addition to these taxes, several smaller taxes and fees apply to imports. Note that most taxes are calculated on a cumulative basis. Customs Regulations It's crucial to ensure all necessary customs paperwork is accurately and thoroughly completed. It's also important to work with a reliable and successful customs broker for the Brazilian market. Products frequently experience delays due to small mistakes or missing details in their paperwork. Items that are held can face significant charges, and Brazilian Customs often confiscate shipments that seem to have incorrect documents. Customs has the authority to impose fines and penalties as it sees fit. The Brazilian government has set up a digital system for tracking imports and streamlining customs clearance, called the Foreign Trade Integrated System (SISCOMEX ), which has lessened the paperwork needed for bringing goods into Brazil. Importers in Brazil are required to be listed in the SECEX Export and Import Registry and are given a password by Customs to access the SISCOMEX system. This system generates digital import documents and sends data to a central database. The system has been enhanced by the Foreign Trade Single Window (SW) Program, which is designed to centralize and enable the electronic submission of import and export documents. The Single Window program has cut down the time it takes to clear customs for maritime shipments to less than ten days, helping over 40,000 importers. How we can help How we can help How we can help How we can help NCM Evaluation We will determine the proper NCM tariff classification, keeping in mind the NCM code during the entire registration process, to get the most out of it. Stay Compliant We will check for updates to the NCM codes and legislation to avoid penalties, shipment delays, and seizure of products by authorities. Market Research We will provide feedback according to our market research to adapt and/or improve your product to fit the needs of the Brazilian users. Evaluate Product’s Marketability We have partnerships with hospitals to evaluate if the product’s characteristics are acceptable by the Brazilian market. Economic Feasibility Studies We can suggest selling price, comparing with other suppliers; run economic evaluation studies to check if the target price for the product is feasible and acceptable by the market Import & Customs Clearance We can provide support for import processes, from start to finish, in addition to defining strategies for tax and duty exemptions. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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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Hosting, Registry Maintenance & Regulatory Compliance Hosting │ BRH The Brazilian Registration Holder (BRH , also known as Host or Hosting service provider ) – in Portuguese “detentor do registro ” – is the company that “owns” the registration and responds directly to ANVISA as the entity legally liable for the medical device in Brazil. The BRH possesses the right to sell and distribute your devices in the Country and is responsible for ensuring the quality and safety of your products in the Brazilian territory. The BRH’s responsibility doesn’t end when the registration is granted . The BRH is also responsible for continuously monitoring the product use, answering to complaints, issuing warning and field actions, keeping the document repository updated, acting as a link between the manufacturer, ANVISA and the users, emitting import and distribution authorizations, etc. So, you need to truly trust your BRH and count on them for sustainable growth. Document Repository In 2020, ANVISA created an online repository for publicly storing and accessing digital documentation of medical devices. With Resolution RDC 751/2022, registration holders are required to add their medical device’s Instructions for Use (IFU) to the repository and ensure that this information is kept updated. The BRHs of newly registered medical products or of previously registered products that undergo changes must ensure that the product’s IFUs are added to Anvisa’s online repository within 30 days of these being published in the Official Federal Gazette (DOU). It is important to note that any public advertising or communication regarding medical devices must be consistent with the information submitted to ANVISA by the BRH. Registry Maintenance & Regulatory Compliance Product Registration Certificates are valid for 10 years and the renewal application must be submitted in a timely manner. Any post-approval changes made to the medical devices must be sent to Anvisa, with relevant documents according to the current requirements. As part of our daily routine, QualiThings follow all official publications, keeping updated with the latest news and regulatory changes. How we can help How we can help How we can help How we can help More Than Just a BRH Where most Brazilian Registration Holders focus only on the registration processes and others only on sales, we work with Regulatory Affairs, Quality Assurance and all aspects related to nationalization, distribution, and commercialization of medical devices. Boutique Services We work as a boutique office with modular services - our clients are free to make their own decisions and pick-and-choose which services they want to hire. Network of Partners We can connect you with our network of partners, distributors, and clients, to expedite market growth. Flexibility to Transfer or Change Distributors Brazilian legislation allows the BRH to give import permits authorizing the distributor(s) of your choice to import your devices, which means you will have full control over your registration, your technical documents, and your products. Keep your Company and Product Compliant We can timely alert the foreign companies in case any prompt action is required to maintain the product registration valid and avoid penalties. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

Marketing & Sales After the medical device is approved for commercialization by Anvisa, selling the product might pose another challenge . In Brazil, the healthcare market is price-driven, with products that are manufactured in-country having a distinct price advantage. The Government of Brazil, which is the sponsor of several hospitals, is the main buyer of healthcare products to supply the Brazilian public healthcare system (SUS ), which is the largest of its kind in the world. Foreign companies can participate in bids, as long as they have a Local Representative . QualiThings has an active database containing the main medical device suppliers, importers, distributors, and clients in Brazil, including over 6,000 public and private hospitals. This system keeps market information updated in real-time. Moreover, our sales services are connected to the public procurement systems in Brazil, allowing foreign companies to access bids throughout the Brazilian territory. Our company also has access to private procurement systems that include opportunities in large hospitals with high demand for health products. Post-Market Surveillance & Customer Satisfaction Assurance Whether you are a small or a large-scale manufacturer, your business expansion , continual improvements , and customer satisfaction rests mainly on the quality standards of your business. Our post-registration services involve evaluating your requirements and suggesting inputs to the business processes that are designed to assure customer satisfaction as well as compliance. How we can help How we can help How we can help How we can help Connect with Clients We offer access to our active database of potential clients, so your company can enter the Brazilian medical device market more quickly. Marketing & Sales Our sales team will focus on lead generation, brand building, and customer engagement, as well as closing deals and generating revenue for your company. Participate in Bids We can work as an Authorized Representative for foreign companies wishing to participate in bids. Customer Satisfaction We will evaluate customer feedback and suggest inputs to the business processes to assure customer satisfaction and compliance. ...and much more! Check out our full business scope Get in touch Send us a message, we will be glad to help you through the pathway into the Brazilian market. +55 (51) 3937-8726 contato@qualithings.com Book a meeting First Name Last Name Email Message Send Thanks for your message! Our specialists will contact you shortly.

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.

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

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