If Active Medical Device Needs To Be Cooperated With Software, With Specified Software Version Listed In The Registration Certificate, When The Software Version Is Updated, Could The Software Information In The Device Certificate Be Updated During Registration Renewal?

Active medical devices and the cooperated software are independent medical devices, each with its own registration certificate, and the version of the cooperated software is permission items of the registration certificate of medical devices, so it cannot be changed during the Registration Renewal.

If the medical device is meant to be used with the updated version of the software, it shall apply for the Change of Permission Items, and provide the safety and effectiveness evidence of the cooperation with the new version of the software. If there5s no Change of Permission Items submitted, the medical device cannot be used with the new version of software, while still be able to be used with the previous version the software.