From the "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 276)
Article 3 The medical devices referred to in these regulations refer to the instruments, equipment, appliances, materials, or other items, including the required software, which are used individually or in combination on the human body; their use on the surface of the human body and in the body is not obtained by means of pharmacology, immunology or metabolism, but may have the participation of, and play an auxiliary role in, these means; and its use is intended to achieve the following intended purposes:
(i) prevention, diagnosis, treatment, monitoring, and mitigation of disease;
(ii) diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;
(iii) study, substitution, and regulation of anatomical or physiological processes;
( (iv) Pregnancy control.