If Medical Device Software Is Updated, When Will It Need To Submit Change Of Permission Items?

First, manufacture should justify weather the update is considered as major update or minor update according to the Guidance fbr technical review of medical device software. It is also needed to justify whether the software version change is considered aspermission items, according to the naming rule and release version in the Product Technical Requirement.

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