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 

Patient safety is one of the cornerstones of healthcare. The National Health Surveillance Agency (ANVISA), as the regulatory body responsible for public health, plays a key role in ensuring the quality and safety of health products. RDC No. 924/2024, by establishing new labeling rules for medical devices that contain latex, demonstrates ANVISA’s commitment to protecting the health of Brazilians. The new regulation contributes to the prevention of severe allergic reactions and promotes safer healthcare practices.  This article provides an in-depth analysis of the implications of these resolutions for healthcare professionals.  RDC No. 924, September 19, 2024  RDC No. 924, dated September 19, 2024, establishes standardized phrases for labeling medical devices containing natural rubber latex.  The regulation mandates that the labels of such products must prominently display the standard phrase: “CONTAINS NATURAL LATEX. MAY CAUSE ALLERGY,” and prohibits the use of the term “hypoallergenic.”  It is optional to use the phrase provided in Section V, Article 8 of RDC No. 825/2023 for surgical gloves and non-surgical procedure gloves made of natural rubber, synthetic rubber, mixtures of both, and polyvinyl chloride, under sanitary surveillance. Additionally, a symbol identifying the presence of latex is allowed, according to ABNT NBR ISO 15223-1:2022, and must be accompanied by the phrase “MAY CAUSE ALLERGY.”  It is important to note that this resolution applies to a wide range of medical devices, including those for in vitro diagnostics, and establishes that non-compliance with these rules constitutes a sanitary infraction, subjecting the responsible party to penalties. The regulation revokes RDC No. 37/2015 and is already in effect.  📝 Access RDC 924/24  RDC Nº 924/24     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 

The regulation of medical products and devices is essential to ensure safety and efficacy in healthcare. In this context, the National Health Surveillance Agency (ANVISA) published Collegiate Board Resolution (RDC) No. 923 on September 19, 2024, which introduces important guidelines for the commercialization and labeling of dental whitening agents. The new resolution reflects ANVISA’s commitment to health safety, revoking previous regulations and establishing specific penalties for non-compliance with the new guidelines. This article analyzes the implications of this resolution for healthcare professionals in detail.  RDC No. 923, September 19, 2024  RDC No. 923, dated September 19, 2024, defines the criteria for the packaging, labeling, and commercialization of dental whitening agents classified as medical devices.  Medical devices intended for dental whitening containing more than 3% hydrogen peroxide, either present or released, require a prescription from a qualified professional in the form of a simple prescription. The commercialization of these products must be directed to qualified professionals and dental service companies, with the presentation of the Professional Council registration, including the registration number on the transaction’s fiscal document.  Dental whitening agents, on their packaging and labeling, must prominently display, in a red stripe, the expression “Sale by Prescription Only.”  In addition, the labeling must include the concentration of hydrogen peroxide, whether present or released from other components or mixtures thereof.  Failure to comply with these provisions of the Resolution may result in sanitary penalties, as per Law No. 6,437/1977, without prejudice to applicable civil, administrative, or criminal penalties. The regulation revokes RDC No. 6/2015 and is already in effect.  📝 Access RDC 923/24  RDC Nº 923/24     The original language version of this announcement is the authorized official version. Translations are provided as a convenience and should refer to the original language text, which is the only version with legal effect.  Click the link to access the Original Version  For 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 

The National Health Surveillance Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices through Resolution RDC 608/2022, published on March 2, 2022. This resolution outlines the requirements for submission and approval of compassionate use programs for medical devices not yet registered in Brazil. The rule is the result of ANVISA’s Public Consultation No. 1,049/2021, which received over 120 contributions from the regulated sector.  Key points of the resolution include:  This resolution demonstrates Brazil’s commitment to balancing patient access to innovative treatments with necessary safeguards. It provides a structured path for patients with severe conditions to access potentially life-saving devices while ensuring proper monitoring and regulatory oversight.  For medical device companies and healthcare professionals, understanding these requirements is crucial to successfully implementing compassionate use programs in Brazil. It is worth noting that custom-made, patient-specific, or adaptable medical devices continue to be regulated by RDC No. 305/2019.  📝 Access the RDC 608/22 :  The text in the original language of this announcement is the official authorized version. The translations are provided for convenience only and should refer to the text in the original language, which is the only version of the text that has legal effect.  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

Xavier Bazin was at Père-Lachaise to pay a final tribute to Professor Luc Montagnier. In recent years, I have had the privilege of having regular conversations with this “great gentleman”. He may have been a Nobel Prize winner, but he was a simple man: our meetings took place in a small, unassuming bistro near the École Militaire, just down the street from his home. Until his last breath, he lit up the world with his intelligence and humanity. And so much the worse for all the ignorant people who criticized him, without having a hundredth of his talent. As Professor Raoult said so well: “In two centuries we will still be talking about Luc Montagnier and all the fools who spoke ill of him will have disappeared in the dust of history. He’s a great gentleman.” For Professor Raoult, it is first and foremost because of his discovery of the AIDS virus that he will remain in posterity. Personally, I think it is his last work on the “memory of water” and the medicine of the future that is the most revolutionary. Professor Montagnier himself said in 2014: “It is now that I find the most important phenomena. Finding a virus is good, but finding the mechanisms of life is even more important.” And indeed: what he was working on was the medicine of the future. In memory of this great man, today I make a point of talking about him in detail – this letter will therefore be a bit long, but I think it is worth it: After the heyday of antibiotics, the decline of chemical medicine Medicine in the 20th century is the result of the pharmacological revolution. After the exciting discovery of antibiotics in the 1930s, thousands of molecules that heal were discovered. In the 1950s and 1960s, it was the heyday of synthetic chemistry. But it didn’t last. By the 1980s, there were almost no new molecules of interest. And in the face of chronic disease, chemistry has generally remained powerless. Alzheimer’s, obesity, cardiovascular diseases, osteoarthritis… Medications do not cure any of these diseases; at best, they stabilize the symptoms… at the cost of serious adverse effects when taken over a long period of time. That is why enlightened doctors also rely on natural molecules that act in depth and without adverse effects: vitamin D, omega-3, probiotics, etc. But in both cases, the medical principle is the same: you depend on a molecule to treat. However, this fundamental principle is in the process of being superseded by a new drug. This is wave medicine, and this is what Professor Montagnier was working on. The origins of “energy” medicine First, let’s dispel a misunderstanding: there is nothing esoteric about wave medicine. As James Oschman explains very well in Energy Medicine, the scientific basis: “In just a few decades, scientists have gone from believing that energy fields in and around the body are pure science fiction to being absolutely sure that they exist.” Yes, there is no doubt that the human body is moved by “electromagnetic” phenomena – and not just by chemical reactions. It has long been known that the heart produces electricity, which is now measured with the electrocardiogram (and what a “pacemaker” is, if not an object that sends an electric current). And who says electricity, says magnetism! It’s a basic law of physics: every electric current produces a magnetic field. Faraday discovered this in the early 19th century, when he noticed that an electric current was turning the needle of his compass! Therefore, each heartbeat also produces an electromagnetic field… that propagates, at the speed of light, even outside the body – we can measure activity at 45 centimeters from the heart. Similarly, we now know that there is electrical activity in the brain, as measured by the electroencephalogram… and that by itself produces a very weak magnetic field. None of this is controversial. This is accepted by everyone. The only question that is being debated is the following: how important are these electromagnetic fields to our cells… for our health… And for living beings in general? For Prof. Montagnier, its importance is paramount: “The paradigm I propose, not only, of course, is that biological molecules do not interact only by contact, by complementarity of form, but also by means of waves. We are then dealing with specific electromagnetic signals, resonance phenomena, remote actions and interference.” What he proposes is a true revolution in biology. Most doctors and biologists believe only in the chemical effects  of biological molecules. But, like Professor Montagnier, I have been convinced for years that this dogma is outdated. In fact, it is very likely that electromagnetic fields are the body’s other means of internal communication. And that the cells of our body communicate with each other in the form of electromagnetic frequencies. Professor Montagnier has even detected very low-frequency waves in viruses and bacteria. According to him, “bacterial germs and viruses use the waves in their DNA to amplify their effect.” And for Professor Montagnier, this “information” would be transmitted by organized water, which memorizes the structures of the molecules, via electromagnetic signals. This is another revolutionary idea, one that is shaking up the scientific community. From this point of view, molecules and chemistry are only part of the functioning of living beings. Each cell, each organ would vibrate at a certain frequency, which would allow it to enter into communication and resonance with the others, like a symphony orchestra. From then on, health would correspond to a perfectly harmonious vibrational concert, with the right electromagnetic frequencies… … And the disease is partly caused by wrong notes, blockages that prevent communication, and our body’s self-repair and self-healing mechanisms. Is this far-fetched? Unscientific? Not at all! The “medicine of magnets” (magnetic) is beginning to be validated in the West! First of all, it is probably no accident that this view of the living is similar to that of the greatest traditional medicines. Thousands of years ago, the Chinese put invisible energy flows at the center of their medicine – and this traditional medicine (TCM),

With the advancement of digital technology, Software as Medical Devices (SaMD) has become an essential part of healthcare innovation. These allow diagnoses and therapies to be carried out through digital platforms, without being tied to specific hardware. To ensure the safety and effectiveness of these products, Anvisa’s RDC 657/2022 establishes regulatory requirements, and the agency also provides a Q&A document to clarify any questions.  In this article, we explore the details of the specifications and criteria for the regulation of SaMD, including topics like cybersecurity, interoperability, validation, and technical requirements, using charts and gap analysis tools to facilitate understanding.  According to RDC 657/2022, Software as a Medical Device (SaMD) is any software with a medical purpose, whether for diagnosis, monitoring, treatment, or other clinical applications, which is not physically integrated with medical hardware. These software programs can be used on various devices, such as smartphones and tablets, and include cloud-hosted systems like Software as a Service (SaaS).  Additionally, Anvisa’s Q&A document clarifies several specific situations, such as the exclusion of software designed solely for administrative management or well-being, which are not subject to regulation.  Practical example: Apps that help monitor well-being, such as tracking physical exercises, do not qualify as SaMD, as they do not have a direct medical function.  Cybersecurity is one of the pillars of regulation for SaMD, as highlighted in both RDC 657/2022 and the Q&A document. Anvisa requires that software be protected against unauthorized access and that processed data remain secure. Additionally, the SaMD must ensure interoperability, meaning the ability to operate with other medical devices or IT systems without compromising functionality. For instance, integration with hospital systems through standard protocols like HL7* is essential to ensure smooth information flow.  *HL7 (Health Level 7) is a set of international standards for exchanging, integrating, sharing, and retrieving electronic health information. These standards are widely used in hospital information systems, laboratories, and clinics, allowing interoperability between different healthcare systems such as hospital management software, medical devices, electronic medical records systems, and other clinical tools.  Key characteristics of HL7:  Practical example:  A hospital using HL7-based clinical management software can easily integrate exam information from different laboratories or patient monitoring with medical devices from various manufacturers. This allows all data to be aggregated into the patient’s electronic medical record transparently. HL7 is essential to ensure that SaMD (Software as a Medical Device) is compatible with other medical systems, enabling efficient communication between software, medical devices, and hospital networks.  The classification of software as medical devices follows Anvisa’s standards, particularly those described in RDC 657/2022 and RDC 185/2001. This classification is divided into four risk classes, based on the impact the software may have on human health:  The Q&A document complements RDC 657/2022 by providing examples of software that may be exempt from regulation, such as medical scheduling apps or symptom control apps without diagnostic purposes.  Document example: Software that only organizes elderly care information without medical or therapeutic functions does not qualify as SaMD and does not require registration.  Validation is a critical process to ensure that the SaMD is capable of fulfilling its function accurately and safely. This includes:  The Q&A document also highlights that even non-innovative software requires validation, although the scope may be smaller.  The Q&A document clarifies various points that may confuse software developers. Here are some frequently asked questions and their answers:  The validation of an SaMD includes both analytical and clinical validation, to ensure that the software is capable of performing its intended function accurately and safely. Anvisa requires robust evidence that the SaMD is effective and safe for clinical use.  Conclusion  The development of an SaMD requires companies to strictly follow the rules of Anvisa in RDC 657/2022. The Q&A document provides additional guidance on common questions, helping ensure that companies meet all regulatory requirements.  📝 Access RDC 657/22 and the Q&A document on SaMD:  The original text of this announcement is the official authorized version. Translations are provided solely for convenience and must refer to the original text, which is the only version that has legal effect.  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