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.
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.