ANVISA: New Registration Regime for Class II Medical Devices

Brazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação). The main goal of this new resolution is to further concentrate on high-risk medical devices and IVDs.

The new notification registration pathway (Notificação) outlines the following rules and requirements applicable for Class II medical devices and IVDs:

  • Unlike the Cadastro pathway, where the manufacturers are obliged to submit comprehensive technical dossiers, labeling materials and proposed Indications for Use (IFU) documents, Notificação  does not require any submissions. However, manufacturers are expected to have all the documentation available and shall make them accessible upon request (in case of an inspection by the ANVISA).
  • A re-validation is not required for Class II devices that are already registered with the ANVISA, except if the changes are requested. However, manufacturers must be compliant with Good Manufacturing Practice (GMP) requirements and any other applicable technical standards and regulations. The initial registration number could be used as a notification number and the additional notification is not required, except for the cases, when certain changes have been made to the devices.
  • For entities responsible for the device changes, it should be sufficient to submit the appropriate notification containing the description of the changes. The sponsor should duly prepare and keep a record of any additional information and must provide it on request. Related notification form for the same could be downloaded from the official ANVISA`s website
  • The device’s labeling information and IFU should meet the general requirements applicable for the appropriate type of device class, under the risk-based classification of medical devices. Labeling of a medical device under the notification procedure should contain the ANVISA’s notification number, which should be in Portuguese and in the form of appropriate symbols.
  • In case if the ANVISA identifies non-compliances or irregularities during the audit or inspection, the Agency is entitled to cancel the notification. If the change notification contains incorrect data, the same rule of cancellation will be applied. The notification can also be canceled upon the request submitted by the sponsors themselves, in case, if they no longer intend to market the medical device in Brazil.

Medical devices and IVD manufacturers aiming for a Brazilian market-entry are obliged to adapt to the  ANIVSA’s new Regulatory framework as mentioned above for streamlined device registration. What is your adaptation approach for the new notification pathway? Chalk it out with a regional Regulatory expert to forgo last-minute challenges. Stay informed. Stay compliant. 

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