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 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.

The new version of Swissmedic's guidance on GMP compliance verification of foreign manufacturers applies to all marketing authorization (MA) holders and their Responsible Persons (RP) in Switzerland.