Brazil’s Anvisa’s Medical Devices for In Vitro Diagnosis Regulation (RDC 830/2023) comes into force in June 2024
Anvisa’s RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024
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.
Annual Updates on Labeling Changes for NDAs and ANDAs Regarding Nonprescription Medications
On March 2024, the FDA is releasing a draft guidance for industry that, once finalized, will offer suggestions to holders of approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for nonprescription drug products on how to document minor labeling changes in their subsequent annual reports.
Ensuring the Thermal Integrity of Pharmaceutical Products in Brazil
Brazil’s Anvisa, legislation provides guidance on the qualification of the transportation of biological products in bulk in their primary and finished packaging.
Consultations Meetings with Anvisa – Health Products
Scheduling your Meeting Consultations with Anvisa: Brazilian System-Parlatory
The USFDA publishes tools to facilitate the registration of cosmetic product listing and facilities
In January 2024, the US FDA announced the availability of SPL Xforms, a structured product label (SPL) authoring tool intended for the registration of cosmetic product facilities and the listing of cosmetic products, as required by the Modernization of Cosmetics Regulation Act (MoCRA).
US FDA Extends Deadline for MoCRA Complaince
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)
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.
US FDA publishes Permanent Accreditation System Conformity Assessment Program
In September 2023, the US FDA issued regulatory updates, to the guidance on the Innovative Devices Program and preliminary guidance on medical devices associated with weight loss.
Registration holder for Medical Devices Imported from Mexico
Registration holder for Medical Devices Imported from Mexico.
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
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.