BRAZIL: new ANVISA notification pathway for Class I medical devices

To streamline the market access for low-risk medical devices, on March 1, 2019, the Brazilian Regulatory Authority ANVISA (Agencia Nacional de Vigilância Sanitária) issued RDC 270/2019, establishing a product notification-based pathway for Class I medical devices and IVD, which consists in a simple communication, replacing the so-called “Cadastro“.

New ANVISA notification pathway for Class I medical devices in Brazil

With the entry into force of RDC 270/2019 in May 2019, the existing device registrations included in the “Cadastro” will be automatically converted into notifications and their notification number will be identical to the (old) registration number.

Once the new pathway comes into effect, ANVISA will issue a notification number to the applicant within 30 days, publishing it on the Agency’s website instead of in the Official Journal. Once issued, the notification number must be added to the product labeling to allow the Manufacturer to market their devices in Brazil.