ANVISA establishes optimized procedure applications for registration of medical devices

by | Apr 9, 2024 | Client Alert, Life Sciences, Regulatory

On April 8th, the Brazilian health regulatory agency ANVISA published a Normative Instruction (290/2024), establishing the optimized procedure on the analysis and decision of applications for the registration of medical devices.

As already mentioned in our earlier communication on March 25th, ANVISA has just authorized the use of evaluations conducted by Equivalent Foreign Regulatory Authorities (EFRAs). Now, this new Normative Instruction defines the criteria for carrying out the optimized procedure for registration of medical devices.

This measure is a major step forward in the adoption of regulatory reliance mechanisms in Brazil and will allow ANVISA to analyze the process of evaluating products already approved before EFRAs more quickly. The adoption of these mechanisms is highly recommended and encouraged by the World Health Organization (WHO) since it allows faster access to health services and technologies for the population.

To apply the new measure, documents must be submitted showing that the products intended for the Brazilian market have the same production characteristics, indications, and intended use approved by the recognized regulatory authority.

Importantly, applications for regularization or post-regularization changes submitted to ANVISA via the ordinary analysis procedure can be resubmitted to the optimized one, if applicable.

Thus, as of June 3, 2024, medical devices authorized for markets regulated by the four following EFRAs may have their analysis shortened, based on the requesting companies’ manifestation.

List of Equivalent Foreign Regulatory Authorities (EFRAs) covered by the Normative Instruction (290/2024):

I – Canadian Health Agency – Health Canada.

II – US Food and Drug Administration (FDA).

III – Australian Therapeutic Goods Administration (TGA).

IV – Japan Ministry of Health, Labour, and Welfare (MHLW) – Pre-market approval (Shonin).

Please do not hesitate to contact us in case you have any questions or if you want us to analyze a particular case. We will be glad to assist you.


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