If active medical device needs to be cooperatedwith software, with specified software version listed inthe registration certificate, when the software version isupdated, could the software information in the devicecertificate be updated during Registration Renewal?
Active medical devices and the cooperated softwareare independent medical devices, each with its own registrationcertificate, and the version of the cooperated software is permissionitems of the registration certificate of medical devices, so it cannot bechanged during the Registration Renewal.
If the medical device is meant to be used with the updatedversion of the software, it shall apply for the Change of PermissionItems, and provide the safety and effectiveness evidence of thecooperation with the new version of the software. If there's noChange of Permission Items submitted, the medical device cannot beused with the new version of software, while still be able to be usedwith the previous version the software.
