Malaysia’s Medical Device Authority issued new mandatory medical device adverse event reporting criteria. If a medical device fails, is found to be not as effective as it claims, or has inadequate labelling or instructions, a report must be submitted within 30 days from the discovery. If the device led to death or serious health defects, a report must be submitted within 10 days from the discovery. Lastly, if it is found that the medical device poses a serious public health threat, a report must be submitted within 48 hours from the discovery. These new medical device adverse event reporting criteria apply to both domestic and foreign manufacturers’ medtech products registered in Malaysia.
