On 11 of December 2023, ANVISA published Collegiate Board Resolution – RDC 830/2023, addressing risk classification, registration procedures, as well as labeling requirements and instructions for use of in vitro diagnostic medical devices (IVDs) in Brazil.

The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates risk classifications and regularization procedures across all IVD risk classes, rendering the previous RDC 36/2015 obsolete. Furthermore, it encompasses procedures for modifications, the mandatory provision of instructions for use in ANVISA’s documentary repository and non-printed formats, leading to the revocation of RDCs 340/2020 and 431/2020, as well as IN 4/2012.

In light of the integration of previously scattered themes in various regulations, the implementation of RDC 830/2023 streamlines the oversight of regulatory processes necessary for upholding the regularization of in vitro diagnostic (IVD) devices with ANVISA.

The risk classification and registration procedures for other medical devices (materials and equipment) remain in line with the directives of RDC 751/2022. Both RDC 830/2023 and RDC 751/2022 share analogous structures and requirements, delineating technical specifics based on each product’s scope.

Key changes in the new resolution include:

• Comprehensive Regulations: RDC 830/2023 consolidates Notification, Registro, changes, and revalidation regulations for IVDs, streamlining compliance requirements;
• The numbering of classification rules closely aligns with EU MDR standards, fostering global regulatory coherence, including:
  • Specific risk classification rules for IVD instruments that do not use reagents; products for detecting transmissible agents, or for evaluating immunological compatibility in cell administration procedures;
  • Classification rules for companion diagnostics and products for neonatal screening;
  • Controls without assigned values are now considered in vitro diagnostic medical devices and must be registered before ANVISA within 1 year after the normative becomes effective;
  • Furthermore, there will no longer be differentiation regarding risk-classification for products aimed at blood gases or glucose, whether or not they are Point of Care Testing (PoCT).
• New definitions, concepts, and modernized text with updated terminology;
• Incorporation of Essential Regulations: The resolution incorporates crucial regulations, including:
  • Modification on registered IVDs: Describes the types of alterations and requirements for petition and implementation. Previously described in RDC 340/2020 (to be revoked);
  • Document Repository: ANVISA’s Documentary Repository for Medical Devices mandates the provision of product instructions for use on the ANVISA website, enhancing accessibility and transparency. Previously outlined in RDC 431/2020 (to be revoked);
  • Non-Printed Format Guidelines: Regulations regarding non-printed format instructions for use and their prerequisites are incorporated, aligning with contemporary documentation practices, applicable for calibrators and controls. Previously described in IN 4/2012 (to be revoked);
• Adoption of the Table of Contents structure (IVD MA ToC) from IMDRF for Technical Dossiers, signaling a commitment to regulatory convergence and international alignment;
• Provision for stock depletion of products, packaging, labels, and instructions for use in the event of changes to in vitro diagnostic medical devices;
• Formalization of the procedural reassessment for in vitro diagnostic devices, a process a process wherein previously approved Notifications and Registros may undergo scrutiny by ANVISA’s technical area;
• For cases of medical devices transitioning from a Notification to a Registro process due to the updated classification rules, the regulation establishes a one-year period from its effective date for the submission of sanitary reclassification petitions.

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By Ângela Soska