Methods for determining expiration date of in vitro diagnostic medical device and significance for signing expiration date / 医疗卫生装备

ABSTRACT

Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.