The Brazilian Health Regulatory Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices in Brazil through RDC 608/2022. This regulation marks a significant step forward in enabling access to innovative medical technologies for patients with serious conditions and no satisfactory therapeutic alternatives. What is Compassionate Use? The Compassionate Use Program allows access to innovative medical devices not yet registered with ANVISA for patients with serious, debilitating illnesses. This program is especially valuable when no satisfactory therapeutic options are available in the country. Eligibility Criteria For a patient to qualify for the Compassionate Use Program, three conditions must be simultaneously met: Responsibilities of the Sponsor The program sponsor holds several key responsibilities: Role of the Attending Physician The attending physician plays a crucial role in the program, being responsible for: Patient Protection The regulation includes various safeguards to protect patients: Timeline and Monitoring The program has a maximum duration of 5 years for patient inclusion, beginning with the enrollment of the first participant. The sponsor must submit annual reports to ANVISA on the program’s progress and a final report within 90 days of program completion. Final Considerations The Compassionate Use Program represents a vital pathway for accessing innovative medical technologies for patients in critical situations. This regulation strikes a balance between the need for new treatments and patient safety, with clear responsibilities for all parties involved. For further information on the Compassionate Use Program for medical devices, consult RDC 608/2022 in full or contact ANVISA. 📝 Access RDC 608/22  RDC Nº 608/2022        The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.  Click the link to access the Original Version  For any questions, contact Brisa Advisors for specialized regulatory support.  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

ANVISA (National Health Surveillance Agency) is the regulatory body responsible for ensuring the safety of products that impact public health in Brazil.  To be a registration holder, it is necessary to have a company that is legally established in Brazil, inspected by State or Municipal Health Surveillance, and authorized by ANVISA through the issuance of a Company Operating Authorization (AFE) to manufacture and/or import products such as food, cosmetics, sanitizing products, medical devices, and medicines. Learn how to choose a hosting service for your company: How to choose a Hosting Service for your company .  In this article, we will discuss the main responsibilities of a registration holder with ANVISA and the regulations governing these activities.  1. Application and Maintenance of Registration  It all begins when the company holding the AFE (Company Operating Authorization) submits a product registration application to ANVISA. This process requires the submission of complete documentation, including safety and efficacy data, in accordance with current regulations and the risk classification of each product. Learn more about risk classification in the following articles: How to Regulate Medical Devices with ANVISA and Notification and Registration of Medical Devices: Differences, Classifications, and the Importance of Regulatory Compliance     The main regulation governing product registration is Law No. 6.360/1976, regulated by Decree No. 8.077/2013. These regulations form the foundation for the registration and commercialization of health products in Brazil.  Key Responsibilities:  2. Post-Market Monitoring of Non-Medicinal Products  After approval and commercialization, the registration holder is responsible for continuously monitoring the safety and quality of the product. This is particularly important for products such as medical devices, food, and cosmetics.  Main regulations:  Key responsibilities:  3. Compliance with Labeling and Advertising Standards  The registration holder must ensure that products are properly labeled and that all advertising complies with ANVISA’s standards. This is essential to prevent misleading consumers about the product’s characteristics or benefits.  Applicable regulations:  Key responsibilities:  4. Good Manufacturing and Distribution Practices  The registration holder must ensure that both the manufacturing and distribution processes follow Good Manufacturing Practices (GMP) and Good Distribution and Storage Practices (GDSP). This ensures that products reach the end consumer with the same quality and safety established during registration.  Applicable regulations:  Key responsibilities:  5. Technical Responsibility  The registration holder must appoint a technical responsible person with specific qualifications to oversee the product’s quality. This person communicates directly with ANVISA on behalf of the company and ensures compliance with all regulations, as required by Law No. 6.360/1976 and Decree No. 8.077/2013.  Key responsibilities:  Conclusion  Being a registration holder with ANVISA involves a series of fundamental responsibilities to ensure that products are safe for consumers. From registration application and maintenance to labeling and ensuring good manufacturing practices, the holder must strictly follow the established regulations.  Staying compliant with these obligations is essential to avoid regulatory issues and ensure that your product remains available on the market.  Want to learn more about the product registration process and the relevant legislation? Contact our specialists!  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Expanding your operations into the Brazilian market is an excellent opportunity for companies in the health, cosmetics, food, and pharmaceutical sectors. However, obtaining ANVISA (Brazilian Health Regulatory Agency) registration to market products in Brazil can be a complex and bureaucratic process. The good news is that there are different approaches to becoming an ANVISA registration holder, each with its own advantages and challenges.  In this article, we will explore the four main options and highlight the pros and cons of each model.  Medical device distributors already established in Brazil have the required health licenses and ANVISA Authorization to apply for registrations. This is a simple and more cost-effective approach to legalizing products in Brazil.  Advantages:  Disadvantages:  Opening your own company in Brazil to directly handle the ANVISA registration process offers full control but requires significant time and investment.  Advantages:  Disadvantages:  Using a BRHS allows foreign manufacturers smoother access to the country, with calculated risks and providing time to learn and adapt to this new market.  Advantages:  Disadvantages:  Acquiring a Shelf Company — a company already registered in Brazil but not yet operational — can be an ideal solution for companies seeking a quick and efficient market entry. This option is becoming increasingly popular among companies looking to avoid the complications of starting a new company from scratch. It’s more recommended for companies with prior experience in the Brazilian market, either through a distributor or a BRHS. We recommend this step as a second phase when your business has matured in the market.  Advantages:  Disadvantages:  Accelerate Your Entry into the Brazilian Market with Brisa Advisors  Now that you understand the main options for becoming an ANVISA registration holder, let’s focus on the most efficient, fast, and secure solutions: the BRHS service or acquiring a shelf company with Brisa Advisors.  At Brisa Advisors, we offer both BRHS services and Shelf Companies for sale, ready to operate, allowing your company to enter the Brazilian market quickly with the security of an already registered structure in full compliance with legal requirements. Here’s why our solution might be ideal for you:  A) For companies unfamiliar with the Brazilian market, we recommend registering through our BRHS, Brazil Import Healthcare Solutions (BIHS). The registration application starts immediately, ensuring safety and reliability for your products.  B) Using the Shelf Company acquisition model, you can request registrations immediately after completing the acquisition process. This is crucial for companies seeking agility and speed in launching their products and is highly recommended for those with prior market experience via distributors or BRHS.  We understand that registration with ANVISA is one of the biggest hurdles for foreign companies. Whether using our BRHS service or acquiring one of our Shelf Companies, it will be possible to immediately start the registration process with ANVISA.  By choosing Brisa Advisors’ services, you eliminate much of the bureaucracy associated with creating a new company. This allows foreign medical device manufacturers to focus on the strategic and commercial aspects of their business.  Unlike options with distributors or starting a company from scratch, by using Brisa Advisors’ services, foreign manufacturers maintain full control over their operation, allowing direct management of sales, marketing, and pricing strategy.  At Brisa Advisors, you will find comprehensive consulting to ensure that your company makes the right choice and maximizes the benefits of this strategy. Our specialists will support you throughout the process, from acquisition to the start of operations.  Comparative Table of Approaches to Becoming an ANVISA Registration Holder  Discretion  Distributor  Start from Scratch  BRHS  Shelf Company  Time to Market Entry  Fast (via licensed distributor)  Slow (until company setup and licenses obtained)  Fast (BRHS has the necessary licenses)  Fast (company already set up)  Control over Operations  Limited (depends on the distributor)  Full control  Partial (BRHS holds regulatory control)  Full control  Initial Investment  Low  High (setup and structure costs)  Medium (BRHS costs)  High (acquisition costs)  Conclusion  If you are looking for a faster and more efficient way to enter the Brazilian market and obtain ANVISA registration, contact Brisa Advisors. With years of experience and expertise in the market, we offer consulting services, BRHS, and ready-to-operate companies, simplifying bureaucracy and speeding up your entry into Brazil.  Get in touch with Brisa Advisors today to discover how we can help your company conquer the Brazilian market with security, speed, and efficiency!  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Introduction  Registering medical devices with ANVISA is a fundamental requirement to ensure the technical compliance and safety of products available in Brazil. Companies that manufacture or import these products need to understand how to navigate ANVISA’s requirements to obtain approval. This detailed guide explores all stages of the registration process, using flowcharts to aid understanding.  Step 1: Company Regularization  Before starting the registration process, the company must ensure it is properly registered with the health authorities.  1.1 Company Operation Authorization (AFE)  Issued by ANVISA, the AFE is the first document the company must obtain. Only companies established in Brazil can apply for this authorization, and in the case of imported products, the importing company assumes this responsibility.  1.2 Local Operating License (LF)  Issued by local (state or municipal) Health Surveillance, the LF is a mandatory requirement for the company to operate. This document ensures that the company meets the necessary sanitary conditions for manufacturing, importing, or distributing medical products.  1.3 Good Manufacturing Practices Certification (BPF)  This certificate is mandatory for manufacturers and ensures that the company follows strict quality standards in the manufacturing process. Certification may involve local inspections by ANVISA or the municipal Health Surveillance.  1.4 Good Distribution and/or Storage Practices Certification (CBPDA)  The Good Distribution and/or Storage Practices Certification (CBPDA) is issued by ANVISA to certify that an establishment complies with the Good Distribution and Storage Practices or Good Storage Practices as provided for in current legislation. It applies to companies storing, distributing, and importing Medicines, Health Products, and Pharmaceutical Inputs located in the national territory, as defined in specific regulations.  Step 2: Product Sanitary Classification  At this stage, the medical device is classified according to the level of risk it poses to health, ranging from Class I (low risk) to Class IV (maximum risk). The classification defines the technical requirements that need to be met.  (For more information about risk classification, access our article Notification and Registration of Medical Devices: Differences, Classifications, and the Importance of Regulatory Compliance)    2.1 Identification of Petition Type  Based on the risk classification, the company must determine whether the device is subject to registration or notification:  Step 3: Electronic Submission  The submission process is done through ANVISA’s electronic system. This service allows the company to formalize its request with ANVISA and obtain information through specific forms. It also enables the generation of the Federal Collection Document (GRU) for paying the Health Surveillance Inspection Fee (TFVS). The company must access the portal and fill in the required information according to the petition type (registration or notification).  3.1 Generate Federal Collection Document (GRU)  At the end of the electronic submission, the company must generate the GRU, which will serve as proof of payment of the inspection fee. The submission will only be considered valid after payment.  Electronic Access Page for Company Registration and Petition Submission:  https://www.gov.br/anvisa/pt-br/setorregulado/administrativo https://www9.anvisa.gov.br/peticionamento/sat/Consultas/ConsultaAssunto.asp Step 4: Submission and Process Review  4.1 Submission  The documentation must be submitted according to the current procedure established by ANVISA’s Documentation Management. In-person service can be performed at ANVISA’s facilities for clarifications regarding the submission procedures. More information on in-person service and submission procedures is available on ANVISA’s website.  It is essential that the petition documents, when submitted, are duly signed by the Legal Representative and the company’s Technical Officer, as required by Article 6 of Law No. 9,784, of January 29, 1999. All documents related to the product (instructions for use, technical report, petition form, label models, etc.) must bear these signatures.  The submitted petition receives a unique number, consisting of 11 digits, followed by the year of submission and ending with a check digit; the full number is called the “protocol number” (example of a protocol number for a petition submitted in 2021: 25352.XXXXXX/2021-YY), which will be converted into a process number + case number (primary process or primary petition) or case number (secondary petition). The company   should monitor the process through the protocol number, process number, or case number on the website.  https://consultas.anvisa.gov.br/#/documentos Be aware that the protocol number does not correspond to the process or case number, as these are generated only after the petition is entered into ANVISA’s computerized system.  It is suggested to check the status the day after the submission. When the company needs information about the process or a specific petition, it should always refer to the process number or case number.  4.2 Technical Review  The process review will be conducted by the Medical Equipment Technology Management – GQUIP. During the review, it is checked whether the documents presented in the registration or notification petition comply with the current health legislation. After review, ANVISA may:  Conclusion  After review and publication in the Federal Official Gazette, the medical device will be authorized for commercialization in Brazil. The registration process may seem challenging, but with an understanding of the steps and good document organization, it is possible to expedite approval.  📑 Learn More – Do you want to understand in detail how the process of registering medical devices with ANVISA can benefit your company and ensure consumer safety? For more information about medical device certification, get in touch with Brisa’s experts. Our team is ready to answer your questions and guide you through all stages of the certification process, ensuring compliance and efficiency. Access now and stay informed! Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

In today’s business environment, many companies are seeking more efficient ways to manage their regulatory compliance functions. The growing complexity and constant evolution of regulatory standards demand a more strategic approach to maintaining compliance and ensuring business success. In this context, BPO in RA (Business Process Outsourcing) stands out as an efficient solution.  BPO in RA involves outsourcing regulatory and compliance activities to a specialized external provider. By transferring these functions to experts, companies can focus on their core activities, reduce costs, and ensure that all legal and regulatory requirements are met effectively.  What is BPO in RA?  BPO (Business Process Outsourcing) in Regulatory Affairs (RA) refers to the outsourcing of business processes, and in the regulatory field, it is gaining prominence due to its ability to simplify compliance management. This model allows a company to partially or fully outsource its regulatory functions, which may include:  In highly regulated sectors, such as medical devices in Brazil, compliance with standards is a fundamental requirement for the entry of new MDs into the market. Additionally, constant regulatory changes make the regulatory process even more challenging.  Benefits of BPO RA for Companies  By adopting the BPO RA model, companies can benefit in several ways, such as:  BRISA Advisors’ BPO RA Services  We offer a complete BPO RA solution, which includes:  Conclusion  The BPO RA model is a strategic solution for companies that want to optimize compliance management, reduce costs, and ensure they stay up to date with current regulations. By relying on the specialized services of BRISA Advisors, your company can focus on what it does best, while we take care of your regulatory needs.  If you have any questions, contact Brisa Advisors for specialized regulatory support.    Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br