Overview of Medical Device Anvisa Regulations in Brazil

Overview of Medical Device Anvisa Regulations in Brazil

The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices.

Anvisa: How can I get a CADIFA anyways?

Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports"

Blog explains the process and How can CADIFA’s are issued and approved by Brazil’s Anvisa. A CADIFA is the Term used by Anvisa to describe an approved DMF for an API in Brazil.

Transfer of Ownership of Registrations at ANVISA

Transfer of Ownership of Registrations at ANVISA

Understanding the Transfer of Ownership of Registrations at ANVISA. The Resolution No 233/2018, began to allow the transfer of registration ownership of products subject to Health Surveillance through commercial operations.

Brazil’s Anvisa Medical Device Single Audit Program

GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.