Marking a significant advancement in regulatory reliance mechanisms, the National Health Surveillance Agency (ANVISA) published Normative Instruction (IN) 290/2024, on April 8, 2024. This normative introduces an optimized procedure for evaluating and deciding on registration petitions for medical devices previously regulated in recognized jurisdictions, aiming to enhance the efficiency of the evaluation process for these products.

According to the IN, effective on June 3, 2024, medical devices classified as risk III and IV, and previously authorized by at least one of the four Recognized Equivalent Foreign Regulatory Authorities (EFRAs) – Australia, Canada, the USA, and Japan – are eligible to undergo optimized dossier analyses upon request from interested companies.

To qualify for review by regulatory reliance, the medical device intended for the Brazilian market must mirror the one already approved by the recognized foreign regulatory authority. Evidence of the registration or authorization issued by the EFRA must be provided, demonstrating that the device to be regulated in Brazil shares identical production characteristics, indications, and uses as approved by the equivalent regulatory authority.

The request for streamlined analysis, including the documents specified by IN 290/2024, must be submitted as a secondary petition along with the registration request. It should be noted that the registration request must still contain documents required by other pertinent Brazilian regulatory standards for medical devices and IVDs, which remain necessary.

ANVISA’s retains decision-making autonomy, allowing independent decisions regardless of EFRA approvals, and may request a standard registration process if necessary.

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