This guideline is intended to guide registration applicantstostandardize the medical device software life-cycle and registrationdossier;standardize the technical review requirements; and provide referencetoquality system inspection for the medical device software andqualitymanagement software.
This guideline is a general requirement for medical devicesoftware,the registration applicant needs to determine the applicabilityof thespecificcontent of this guideline according to the product characteristicsandrisklevel. Detailed reasons shall be provided for inapplicability. Registrationapplicants may also use other alternative methods to meet regulatoryrequirements but need to provide detailed research information.
