Over the past two years, Brazil's regulatory landscape for medical devices has undergone substantial changes. In 2022 and 2023, Brazil’s National Health Surveillance Agency (ANVISA) introduced a series of resolutions that have reshaped the regulation of medical devices, including In Vitro Diagnostic Devices (IVDs), Software as a Medical Device (SaMD), and how their clinical studies are carried out. These updates are part of a broader movement towards modernizing and harmonizing regulatory practices to ensure safety, effectiveness, and global consistency.
In this evolving context, RDC 830/2023 stands out as a crucial regulation that significantly alters the oversight of IVDs in Brazil. This blog delves into RDC 830/2023, examining its key provisions, implications for stakeholders, and its integration into the broader regulatory framework.
ANVISA Regulation of IVDs in Brazil : RDC 830/2023
On December 11, 2023, ANVISA released Collegiate Board Resolution (RDC) 830/2023, marking a major shift in IVD regulation. This comprehensive regulation introduces new procedures for risk classification, registration, and labeling of IVDs. Effective from June 1, 2024, RDC 830/2023 will replace RDC 36/2015 and consolidate various regulations into a unified framework. It will also revoke RDCs 340/2020 and 431/2020, as well as IN 4/2012.
Alignment with Resolution RDC 751/2022
RDC 830/2023 is aligned with RDC 751/2022, ensuring consistency in regulatory processes for IVDs and other medical devices. This alignment promotes a unified approach to risk classification and registration.
What Does RDC 830/2023 Cover?
RDC 830/2023 provides a streamlined and consolidated approach to IVD regulation in Brazil. Key elements include:
Consolidated ANVISA Regulations for IVDs in Brazil: The resolution merges various regulations into a single framework, covering Notification, Registro, modifications, and revalidation. However, RDC 848/2024 on Essential Safety and Performance must also be consulted for IVDs entering the Brazilian market.
Table of Contents Structure: Adoption of the Table of Contents structure (IVD MA ToC) from IMDRF for Technical Dossiers reflects a commitment to international alignment.
Stock Depletion: Guidelines for stock depletion of products, packaging, labels, and instructions for use are established in the event of changes to IVDs.
Procedural Reassessment of IVDs: Formalization of the reassessment process for IVDs, where previously approved Notifications and Registros may be reviewed by ANVISA’s technical area.
Risk Classification and Registration of IVDs under RDC 830/2023
The resolution aligns risk classification rules more closely with EU MDR standards, ensuring global regulatory coherence. It introduces specific classification rules for IVD instruments that do not use reagents, those for detecting transmissible agents, companion diagnostics, and neonatal screening products.
Control devices without assigned qualitative or quantitate values are now classified as IVDs and must be registered within one year of the resolution’s effective date. The differentiation between risk classifications for products like blood gases or glucose is also removed irrespective of whether they are Point of Care Testing (PoCT) or not.
Changes in Risk Classification of IVDs under RDC 830/2023
The RDC 830/2023 presents IVDs who risk classification have changes in comparison with the older regulations. The change categories are included in the lists –
Class III to Class II
Class II to Class III
Class IV to III
Class II to IV
Class III to IV
Of all the categories, most of the IVDs have been a change in Class II to Class III
Examples of Classification Changes
The resolution introduces notable changes in IVD risk classifications:
VEB (Epstein-Barr): Previously Class II, now Class IV.
Hemoglobin Subtype: From Class II to Class III.
Neisseria, Zika, Chlamydia, Parvovirus, Plasmodium: From Class III to Class IV.
Control Devices: Previously unclassified, now classified as Class II.
Guidance on Multi-Class IVDs under RDC 830/2023
ANVISA has published guidance for IVDs with multiple risk classifications. For instance, products like 17-Hydroxyprogesterone, amino acids, and Anti-TSH receptor antibodies are Class II IVDs, but are classified as Class III if used for neonatal screening. The resolution includes the technical name, risk classes and whether the IVD should follow Notification or Registro pathway.
Regulatory Requirements for IVDs under RDC 830/2023
Products transitioning between Notification and Registro due to updated classification rules must be reclassified within one year of RDC 830/2023’s effective date. Manufacturers have 120 days to update labels to reflect new terminology. The resolution also establishes a 120-day period for depleting stock of packaging, labels, and instructions.
Class I and Class II IVDs – Notification
Class III and Class IV IVDs – Sanitary Registration
Updated Terminology and Definitions in RDC 830/2023
RDC 830/2023 incorporates new definitions and updated terminology, reflecting modern practices and enhancing clarity in regulatory requirements.
Essential Regulations under RDC 830/2023
The resolution incorporates key regulations from previously revoked RDCs 340/2020 and 431/2020, such as:
Modification Procedures: Outlining the types of alterations and requirements for modification petitions.(earlier covered under RDC 340/2020)
Document Repository: Mandating the provision of product instructions for use on ANVISA’s website, improving accessibility and transparency. (earlier covered under RDC 431/2020)
Non-Printed Format Guidelines: Regulating instructions for use in non-printed formats and their pre-requisites for calibrators and controls. (earlier covered under IN 4/2012)
New Labeling Requirements for IVDs under RDC 830/2023
Under the new regulations aligned with RDC 751/2022, the term “importer (importador)” will be replaced with “regularized by (regularizado por)” on IVD labels. Companies have 120 days from June 1, 2024, to update their labels accordingly.
IVDs Exempted from RDC 830/2023 Registration Requirements
Certain IVDs are exempt from notification or registration, including:
IVDs intended solely for clinical investigations, with restrictions on commercialization and use.
Multi-device presentations with packaging that includes information for each device, including notification or registration numbers.
Transition and Compliance with RDC. 830/2023
For products whose classification has changed, manufacturers must review and adjust their regulatory status accordingly. Products transitioning from Notification to Registro due to updated classification rules have a one-year (365 days) period to submit sanitary reclassification applications. The resolution also sets a 120-day period for adapting labels and packaging to the new terminology and requirements and to deplete the stock of existing labels and IFUs.
Manufacturers are encouraged to conduct a gap assessment comparing RDC 36/2015 with RDC 830/2023 to ensure compliance. It is crucial to review the classification of IVDs and make necessary adjustments to align with the new regulations. One may refer to Annex I of the RDC 830/2023 which details the rules for risk classification of IVD medical devices in Brazil. For assistance with navigating these changes and ensuring compliance, contact our team at Artixio.
For personalized guidance on RDC 830/2023 and to ensure a smooth transition to the new regulatory framework, reach out to Artixio at info@artixio.com. Stay informed and prepared as Brazil’s regulatory landscape evolves. We are here to support you through these changes!
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