TGA Updates Guidance on Medical Device Application Audit Selection Criteria
The TGA has updated its guidance on how medical device and IVD applications are selected for audit before inclusion in the ARTG.
IMDRF Presents Playbook for Evaluating Medical Devices Based on Artificial Intelligence
The IMDRF has published a Playbook for the evaluation of Artificial Intelligence and Machine Learning (AI/ML) medical devices, addressing safety, efficacy and regulatory requirements. Global harmonization of these medical devices is essential to ensure transparency, reliability and compliance.