Health Product Labelling Requirements for Imported Products into Brazil

The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.

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.