Although DTx products do not have pharmaceutical ingredients that enter the body, they influence or interact with human subjects (ie, patients) through information (eg, text, pictures, videos) and physical factors (eg, sound, light, electricity, magnetic fields, and combinations thereof), etc. In general, if the DTx product has any diagnostic, preventive, monitoring, therapeutic, or palliative functions, it falls into the definition of a medical device, which will require filing or registration with the National Medical Products Administration (NMPA) or its local counterparts, depending on its classification. Currently, the major indications for DTx products are ophthalmic diseases, psychiatric diseases, endocrine system diseases and neurological diseases. Among the approved DTx products in China, products treating ophthalmic diseases account for the largest proportion, followed by products for cognitive function therapy. Most of these DTx products are registered as Class II medical devices.
Developing and registering DTx products as medical devices allows more freedom in developing functions and making claims, but is subject to more stringent regulations and supervision, especially when it comes to promotion and advertisement.
At present, if deemed as medical devices, DTx products are most likely classified as medical device software (ie, Software as Medical Device – SaMD) under Classified Catalogues of Medical Devices. However, although there are five subcategories of medical device software, none of them may completely and perfectly suit DTx products. As there is no regulation or guidelines specifically promulgated for the registration of DTx products in China, the general requirements for medical device software apply, including the Guidelines for Technical Review of Medical Device Software Registration, the Guidelines for Technical Review of Mobile Medical Device Registration, and Guiding Principles for the Classification and Definition of AI-based Medical Software Products. DTx products can be registered as independent software or software components. The post-market updates of such software also require subsequent regulatory filing or approval depending on the outcome and impact of the update.
If a DTx product is developed, registered and operated as a medical device, it is subject to various medical device-related regulations in clinical trials, registration and filing, manufacturing, distribution and promotion, including but not limited to the Regulations on Supervision and Administration of Medical Devices, Administrative Measures for Registration and Filing of Medical Devices, Supervision and Administration Measures for Manufacturing of Medical Devices, Supervision and Administration Measures for Distribution of Medical Devices, Good Clinical Practices for Medical Devices (GCP), Good Manufacturing Practices for Medical Devices (GMP), Good Supply Practices for Medical Devices (GSP), and the special restriction for medical device promotions in the Advertising Law.