IMDRF Releases Key Guidance Documents for Medical Device Software

IMDRF Releases Key Guidance Documents for Medical Device Software

The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.

Mexican Ministry of Health Advances with SaMD

Mexican Ministry of Health Advances with SaMD

The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).

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?

Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports"

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.