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.

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.

US FDA Extends Deadline for MoCRA Complaince

The FDA publishes tools to facilitate the registration of cosmetic product facilities and the listing of cosmetic products.

On November 8, 2023, the U.S. Food and Drug Administration (FDA) announced its intention to extend the enforcement deadline for cosmetic product facility registration and listing requirements as established by the Cosmetic Modernization Regulation Act of 2022 (MoCRA). The six-month extension is intended to provide industry with additional time to comply with the required facility registration procedures and provide detailed information on cosmetic products, thereby ensuring a smooth transition to the new regulations.

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.