According to“Guidance for Product Technical Requirementof medical device”, the product model and/or specifications shallbe clearly defined in the Product Technical Requirements, as wellas the description of their division rule. For products with multiplemodels and/or specifications in the same registration unit, alldifference between models and specifications shall be clarified (thecorresponding drawings may be attached if necessary). Texts ortables of large scale could also be provided in the appendix.
For stand-alone software or software components,the name.model, release version, and the naming rules of the full versionof software also need to be clarified. For the controlling softwarecomponents,the operating environment (including hardwareconfiguration,software environment and network conditions) is alsoneeded.