US FDA Publication on Integrating Artificial Intelligence into Healthcare Product

On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.

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?

How does Product Regulation Work at ANVISA?

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.