Changes to Class I Medical Device Requirements in Brazil
Agência Nacional de Vigilância Sanitária (ANVISA) is the regulatory body responsible for the regulation and approval of pharmaceuticals and medical devices in Brazil. On March 3, 2019, ANVISA published a regulation, RDC 270/2019, which establishes a notification pathway for Class I medical devices and IVDs. This new regulation exempts low-risk medical devices from the requirement of undergoing a full Cadastro registration process and in effect allows manufacturers to access the Brazilian market much quicker. This notification pathway will go into effect in May, 2019.
As of now, ANVISA provides two separate pathways for medical device approval. The first pathway, Cadastro, is meant for low-risk medical devices, while the second registration pathway, Registro, has been established specifically for high-risk medical devices.
The implementation of this notification pathway will not change the required documentation (technical dossiers, ANVISA application forms) for Class I medical devices who are on the Cadastro registration route. However, these low-risk medical devices will no longer have to undergo technical reviews and instead they will be notified to ANVISA to be issued notification numbers. Manufacturers may begin marketing their devices in Brazil after receiving notification numbers and including them on the label of the device. The issuance of notification numbers is not expected to take more than 30 days after the submission date.
Manufacturers should also be aware of the fact that ANVISA can cancel granted notifications at any time. The reasons vary from incorrect classification to lack of proper documentation or complaints.
Class I medical device notifications will not expire. Also the 180-day limited stock depletion period for Class I devices will no longer apply as of May, 2019.