First. manufacture should justify weather the update isconsidered as major update or minor update according to theGuidance for technical review of medical device software. It is alsoneeded to justify whether the software version change is consideredaspermission items, according to the naming rule and release versionin the Product Technical Requirement.

If the update is considered as a major update with the changeof release version, then Change of Permission Items is needed.Ifthe update is considered as a minor update with the release versionunchanged, administrative counterparts could manage it throughthe quality management system without submitting Change ofPermission Items, but all the relevant research information ofsoftware should be provided during the next submission (Change ofPermission Items or Registration Renewal).