How Does NMPA Supervise The Sleep Respiratory Monitoring APP Installed On The Patient’s Mobile Phone?
2021-10-18
How to supervise depends on the specific function and purpose of the APP. If the APP can only record and display data without the function of data processing and calculation, and its displayed data is not used for diagnosis or treatment, the APP will be classified as non-medical devices and NMPA will not supervise it.
If the data of APP is used to assist diagnosis and treatment, and does not involve artificial intelligence technology and big data technology based on deep learning, it shall be supervised according to class II medical devices, with classification code of 21-03.
