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New guidelines for the regulation of medical devices in Brazil will become effective in 2023

Incorporating Mercosur Resolution GMC no. 25/2021, Anvisa has recently published the Resolution of the Board of Directors – RBD no. 751/2022, which will come into force on March 1, 2023.

The Resolution defines the risk classifications, labeling requirements, and instructions for use, in addition to the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices.

In this sense, the new RBD no. 751/2022 fulfills the function of consolidating a series of other regulations issued by Anvisa that deal with the regularization of medical devices.

In addition, the Resolution also establishes mandatory labeling requirements and instructions for use of medical devices, especially related to information about risks, use, and conservation, as well as procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices.

The RBD no. 751/2022 also determines that medical devices must be classified according to the risks to human health that they may present, following the definitions made by Anvisa itself.

According to the new RDC, the devices can be classified into the following categories:

(a) Class I: low risk;

1. b) Class II: medium risk;
2. c) Class III: high risk;
3. d) Class IV: maximum risk.

Moreover, the Resolution establishes that Anvisa may require laboratory verification for evaluation and certification of medical devices, as well as other analysis procedures and technological surveillance, depending on the risk associated with the device.

The new RBD also requires medical device manufacturers to participate in safety monitoring programs to ensure that the devices are safe for clinical use.

Bearing that in mind, it can be said that RBD No. 751/2022 is an important step towards more effective regulation in the area of medical devices, making the regulatory process safer and more streamlined.

These are the main changes foreseen in Anvisa’s new RBD and it is important to highlight that the guidelines must be followed by manufacturers of medical devices to ensure the proper functioning of the machines and the safety of users.

Thus, starting in March 2023, Anvisa will accept medical device registration petitions with the technical report structure provided for in the old RBD, No. 185/2001, if they are filed until February 28, 2023.

Aiming to support companies’ compliance with this new Resolution, ClarkeModet Brazil has collaborators skilled in the matter, which, from an understanding of the client’s specific situation, draw strategies that aim to keep the client in accordance with the regulatory provisions and avoid future impasses.

The Resolution of the Board of Directors – RBD nº 751/2022 can be found at the following link: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-751-de-15-de-setembro-de-2022-430797145

Patrícia Corrêa