Brazil – ANVISA eliminates Cadastro pathway for Class II medical devices

According to the Resolution, Class I and II devices henceforth only require a Notification (Notificação) and are not subject to approval prior to commercialization. Manufacturers will also not be required to submit a technical dossier, but they are expected to have it available upon request. The Notificação pathway was put into place last year and initially replaced the Cadastro for Class I devices only…