Medical devices play a fundamental role in the practice of modern medicine, offering a variety of essential tools for diagnosis, treatment, and monitoring of health conditions. These devices range from simple equipment such as thermometers and glucose monitors to advanced technologies like magnetic resonance imaging and medical implants. By enabling early disease detection, enabling less invasive procedures, and ensuring more efficient monitoring, medical devices contribute significantly to the advancement of health and well-being of the population.  Among the various types of medical devices – as defined by RDC nº 751/2022 – in vitro diagnostic medical devices stand out due to their multiple applications in the healthcare field. Because it is a complex and specialized regulatory subject, in vitro diagnostic products (IVDs) are governed by a specific resolution: RDC nº 830/2023.  By definition, an IVD is a reagent, software, sample collector, or other article used for the in vitro analysis of samples derived from the human body, exclusively or primarily, with the purpose of providing information for diagnostic, monitoring, compatibility, screening, or determination of physiological status.  The classification is carried out following the guidelines of RDC nº 830/2023, according to the most applicable rule for the product. Following this analysis and determination of the class, the process of petitioning for notification or registration with ANVISA begins.  The classification establishes the type of process that will be submitted: IVD products of Class I and II are subject to notification, while those of Class III and IV are subject to registration. In the case of notifications, the technical analysis of documents by ANVISA constitutes a more simplified process. Specifically for Class I, it is not   necessary to prepare a technical dossier, only to submit certain information. For products targeted for registration, it is necessary to submit, in addition to the technical dossier, a Good Manufacturing Practice (GMP) Certificate process to ANVISA as a prerequisite.  According to Regulatory Instruction nº 320, dated September 2024, in vitro diagnostic medical devices that are included in a grouping list for IVD families can be registered or grouped as a family, provided that a series of requirements are met. These include the stipulation that they must be products of the same composition, technology, legal manufacturer, and intended for interdependent and exclusive use.  Furthermore, besides the mentioned documents, an IVD product may also require a Conformity Certificate or a pre-analysis report deemed satisfactory by a unit of the National Network of Public Health Laboratories (INCQS). This applicability should be evaluated on a case-by-case basis, according to the specificities of the product.  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 

As of June 2025, ANVISA has implemented a strategic change that demonstrates its commitment to optimizing regulatory processes in the pharmaceutical and medical device sectors. What changed in practice? BEFORE: The renewed Good Manufacturing Practice Certificate (CBP) validity started from the publication date, creating temporal discontinuity. NOW: The renewal validity starts exactly on the last day of the current certification, ensuring perfect continuity. Practical example: Key benefits: For companies: For the regulatory system: Impact on the Consultation Portal An important change: renewals published before the current certification expires will not appear on the Portal until they are effectively in force, avoiding confusion and ensuring clarity in consultations. Industry reflection This change reflects Brazilian regulatory maturity, prioritizing operational efficiency and legal certainty. For regulatory affairs professionals, it represents further evidence of the importance of continuously monitoring ANVISA updates. How is your company preparing for these regulatory changes? 💬 Share your experience in the comments about how these changes impact your processes Need regulatory affairs consulting? Contact me to discuss how I can help your company navigate these changes. 📎 Reference:ANVISA. Anvisa altera forma de contagem da validade do Certificado de Boas Práticas. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-altera-forma-de-contagem-da-validade-do-certificado-de-boas-praticas. Accessed: Aug. 2025. #ANVISA #RegulatoryAffairs #GoodPractices #Pharmaceutical #RegulatoryQuality #CBP #BrazilianRegulation

IntroductionThe concept of family in medical device regulation represents a sophisticated approach to optimize regulatory processes while maintaining safety and efficacy standards. Under Brazil’s RDC 751/2022, the family classification system provides significant advantages for manufacturers seeking efficient pathways for medical device registration in the national market. Regulatory Definition According to RDC 751/2022, a family consists of a group of medical devices intended for notification or registration, as defined by specific regulation. Each product in the family must share similar technical characteristics across five key dimensions: Strategic Advantages Regulatory Efficiency Family registration under RDC 751/2022 enables manufacturers to leverage documentation across multiple related products, significantly reducing the documentation burden and accelerating market access. This approach facilitates the entry and maintenance of multiple products in the market. Cost Optimization · Lower regulatory fees· Simplified documentation requirements· Shared technical evaluations· Economies of scale in regulatory processes Faster Product Development · Accelerated product line extensions· Shorter time-to-market for variants· Improved competitive positioning· Optimized allocation of resources Technical Requirements Standardized Documentation Family submissions must demonstrate technical equivalence through standardized documentation, covering:· Comparative risk analysis· Shared manufacturing processes· Common components· Harmonized regulatory requirements Regulatory Pathways Notification vs. Registration Under RDC 751/2022, family classification affects regulatory routes:· Class I–II Devices: Subject to notification procedures· Class III–IV Devices: Require full registration processes Classification Considerations All products within a family must demonstrate consistent risk profiles and a justified classification. ANVISA’s requirements dictate that risk assessment methodologies must be aligned across all family members. Practical Implementation Aspects Required Documentation To submit a family registration, manufacturers must provide, among others:· ANVISA forms· Technical dossier· Evidence of technical equivalence· Safety and performance analysis· Demonstration of GMP compliance (if applicable) Market Access Strategy Strategic planning based on families enables:· Accelerated product line extensions· Reduced time-to-market· Improved competitive positioning· Optimized use of regulatory resources Sustainable Competitive Advantage Family registration offers long-term regulatory and market benefits:· Simplified regulatory maintenance· Lower registration costs· Faster innovation cycles· Greater responsiveness to market demands Challenges and Considerations Technical Complexity · Need for strict demonstration of technical equivalence· Maintaining consistency across multiple products· Managing technical changes over time Conclusion The family classification system under RDC 751/2022 is a sophisticated regulatory tool that balances operational efficiency with high safety standards. For manufacturers navigating Brazil’s complex regulatory landscape, family strategies provide competitive advantages in cost, speed, and market access. Implementing family concepts strategically requires a thorough understanding of technical requirements, regulatory pathways, and quality system implications. Organizations aiming to optimize their market strategy in Brazil should consider family approaches as integral components of their regulatory planning. Successful implementation of medical device families depends on careful planning, rigorous documentation, and consistent quality standards across all grouped products. With the right approach, family strategies represent a significant opportunity for regulatory optimization and sustainable competitive advantage. For expert guidance on family registration strategies and RDC 751/2022 compliance, contact our specialists to discuss your specific needs and develop a customized strategy for registering your medical device in Brazil. 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 w