Brasília – The National Health Surveillance Agency (Anvisa) has unified the subject-codes used in petitions related to the Good Manufacturing Practice Certificate (CBPF) of medical devices. This measure aims to reduce regulatory complexity and streamline the certification process for medical devices — including in vitro diagnostics — aligning with the framework set by RDC 665/2022.

Under the new rule, all petitions for medical-device manufacturers — whether domestic, international or from Mercosul — will use a standardised set of petition-subjects, facilitating consistency and integration with the Medical Device Single Audit Program (MDSAP).

The measure will not affect petitions already submitted or under review.

Source: Anvisa