Mexico: New Rules of IVD Medical Devices Updated by ANVISA (1 June 2024)

ANVISA published a new Collegiate Board Resolution, RDC 830/2023 on the 11th of December 2023, updating the rules for in-vitro diagnosis medical devices (IVDs) and will be rolled out effectively on 1 June 2024.

The revision consists of risk classification consolidation, procedures for notification, registration, amendment, revalidation, cancellation of notification or registration, and labelling requirements for IVD medical devices. ANVISA intends to streamline the Brazilian regulatory pathway and align with international practices.

Significant revisions were decided based on the risk of the IVD medical devices that may affect public health and users:

• Provide specific risk classification rules for IVD medical devices that do not use reagents; for products aimed at detecting transmissible agents or for immunological compatibility evaluation in cell administration procedures

• Provide classification rules for companion diagnoses of IVD medical devices and neonatal screening medical devices

• Any medical devices that are controlled without assigned values now have been classified as IVD medical devices and the responsible person must notify Anvisa within 1 year period of the new RDC enforcement

• The health risk differentiation for the medical devices aimed for blood gases or glucose either under the Point of Care Testing type (PoCT) or not has been demolished.

• Addition of permission to use instructions for use in non-printed format for controls and calibrators together with the previous requirements stated in Normative Instruction (IN) 04/2012

The responsible person should stay apprised of the enforcement date of the RDC 830/2023 and take action on any IVD medical devices classification to be modified since Anvisa provides 1 year period to file for the reclassification.

Source: National Health Surveillance Agency (ANVISA)

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