Hospitals directed to report serious medical device incidents within 15 days
Healthcare authorities have issued a directive requiring hospitals to report serious medical device incidents and adverse events to regulators within 15 days of occurrence. The mandate aims to strengthen oversight of medical equipment safety and ensure faster identification of potential risks.
The reporting requirement covers critical device failures, malfunction-related patient injuries, and other significant adverse events. This accelerated timeline is intended to enable quicker regulatory response and prevent recurrence of similar incidents across healthcare facilities.
