If The Registrant Claims That A New Clinical Function Of A Medical Device With Software Is A Minor Change, Is It Possible To Ignore Such Change In The Release Version?

Definitely not. Changes in clinical functions shall be major updates of software. If the naming rules for software version number specified by the manufacturer cannot clearly distinguish major and minor software updates, software release version number shall follow its higher risk. The software release version in China shall reflect such changes.

For example, the naming rule of software version number developed by the manufacturer is X.Y.Z, of which X represents major update, Y represents minor update and Z represents correction. If the change of clinical function is reflected in the Y field, the software release version number shall be determined as X.Y.