On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the elimination of the Cadastro system for the registration of Class II Medical Devices and IVDs, while for Class III and IV devices the registration process remains unchanged.

Brazil Cadastro eliminated also for Class II Medical Devices
Cadastro eliminated also for Class II Medical Devices

For Class I and Class II devices a notification is sufficient

Anvisa has decided to extend this Resolution to Class II devices to further concentrate regulatory resources on the supervision of high-risk Medical Devices and IVDs, also allowing faster access to the Brazilian market for more device Manufacturers.

Before the elimination of the Cadastro system, Manufacturers of Class I and Class II devices have to provide complete technical files and materials for labelling and instructions for use (IFU) to their Brazilian Registration Holder (BRH), that is Local Authorized Representatives responsible for submitting the documents necessary for the registration procedure at ANVISA.

Now, according to the Resolution that eliminated the Cadastro system, Manufacturers of these devices are not required to submit a technical file, but this documentation must be available in case of audit by ANVISA. In addition, only a notification is required for these devices (Notificação) and they are not subject to approval by ANVISA before being marketed in Brazil.

Previously registered Class II products will automatically be considered as notified and they will not require re-validation except where Manufacturers submit requests for changes to registrations.

The Notificação system was established in 2019 and initially it had replaced the Cadastro only for Class I devices, that is low-risk devices. Now, this system has also been extended to Class II devices.

Do you need more information about the Brazilian regulation?

Consult our Country Profile Medical Device registration in Brasil.

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ANVISA RDC n. 423/2020