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 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.

US FDA Publish Additional Condition for Nonprescription Use (ACNU)

FDA Publish Additional Condition for Nonprescription Use (ACNU).

On June 2022, the FDA introduced a new regulation aimed at establishing criteria for over-the-counter drugs that carry an Additional Condition for Nonprescription Use (ACNU). This initiative seeks to expand the range of drugs that the FDA could authorize for over-the-counter use.

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.