In The Product Technical Requirements Of Active Medical Devices, How To Compose The “product Mode And Specification And Instruction For Division”?

According to “‘Guidance for Product Technical Requirement of medical device”, the product model and/or specifications shall be clearly defined in the Product Technical Requirements, as well as the description of their division rule. For products with multiple models and/or specifications in the same registration unit, all difference between models and specifications shall be clarified (the corresponding drawings may be attached if necessary). Texts or tables 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 version of software also need to be clarified. For the controlling software components, the operating environment (including hardware configuration, software environment and network conditions) is also needed.