1, the application facts: when filling in the application facts, you need to include the basic information of the medical device, such as the name, model, use, scope of application. At the same time, you also need to fill in the production and use of the medical device, such as manufacturer, date of production, instructions for use, sales and so on.
2, the rationale: in filling out the rationale, you need to explain the clinical significance of the medical device, market demand, technical characteristics and other aspects of the information. In addition, it is also necessary to explain the difference between the medical device and the existing medical devices, advantages, safety and other information to prove that the medical device is in line with relevant standards and requirements.