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