Saudi FDA Issues Guidance on Medical Device Bundling
Saudi FDA medical device bundling MDS-G28 explains when device groupings may share one MDMA application and when separate submissions are needed.
Category Regulatory Insights
Malaysia and Thailand Implement Medical Device Regulatory Reliance Programme
Malaysia–Thailand medical device reliance supports Class B, C, and D registrations through streamlined pathways between MDA and Thai FDA.
Chile Expands Sanitary Control for Medical Devices and IVDs
Chile medical device registration expands to 39 higher-risk devices and IVDs under Decree No. 25, with phased compliance through the ISP.
FDA Signals 510(k) Relief for Additional Unclassified Devices
FDA 510(k) exemption guidance adds five unclassified device codes to enforcement discretion while formal exemptions remain pending.
UK MHRA Publishes Draft Pre-Market Requirements for Medical Devices and IVDs
UK MHRA pre-market requirements propose changes to international reliance, UDI, implant cards, IVD classification, documentation, and device claims.