Sep 20, 2020

On September 18, Brazil’s National Health Surveillance Agency (ANVISA), published RDC No. 423/2020 (link in Portuguese), a new Resolution of the Collegiate Board of Directors (RDC) declaring the elimination of the Cadastro pathway for the registration of Class II medical devices and IVDs.

Notificação pathway now covers both Class I and Class II products

According to the Resolution, Class I and II devices henceforth only require a Notification (Notificação) and are not subject to approval by ANVISA prior to commercialization in Brazil.

Under the Cadastro system, manufacturers of Class II as well as some Class I devices were required to provide comprehensive technical dossiers, labeling materials and proposed indications for use (IFU) documents to their Brazilian Registration Holder (BRH) in-country representatives. Now, manufacturers will not be required to submit a technical dossier, but they are expected to have such documentation available upon request in the event of audits by ANVISA. The Notificação pathway was put into place in 2019 and initially replaced the Cadastro for low-risk Class I devices only.

Previously registered Class II products will automatically be considered to be notified and will not require re-validation except in instances where manufacturers submit requested changes to their registrations. RDC 423/2020 also contains updated documentation requirements for the Notification of Class I and II medical devices and IVDs, effective immediately. 

The extension of RDC 423/2020 to Class II devices enables ANVISA to further concentrate regulatory resources on oversight of higher-risk medical devices and IVDs, while also enabling more streamlined Brazilian market access for a greater number of device manufacturers.

Learn more about Brazilian medical device regulations at Emergo by UL:

 

Author

  • Timothy Herr

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