Anvisa Publishes Guidance Manuals for Medical Device Regularization
Anvisa has published two guidance manuals for the regularization of IVD devices and notification of risk class I and II medical devices, aiming to improve dossier quality and reduce technical requirements and rejections.
Anvisa Publishes Manual on Notification of Risk Class I and II Medical Devices
Anvisa has published a manual on the notification process for risk class I and II medical devices in Brazil, covering company regularization, product classification, Solicita electronic submission, documentation requirements and secondary petitions.