How is a medical device defined in China's Medical Device Supervision and Administration Regulations?

"Medical Device Supervision and Administration Regulations" states: medical device, refers to instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly for the human body, including the required computer software; its utility is mainly obtained through physical and other means, not through pharmacological, immunological or metabolic means, or although these means are involved but only play an auxiliary role; its purpose is:

(a) diagnosis, prevention, guardianship, treatment or alleviation of disease; or involved but only in an ancillary role; and which are intended for:

(i) the diagnosis, prevention, monitoring, treatment, or mitigation of disease;

(ii) the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury;

(iii) the testing, substitution, modulation, or support of physiologic structures or physiologic processes;

(iv) the support or maintenance of life;

(v) Pregnancy control;

(vi) Providing information for medical or diagnostic purposes through the examination of samples from the human body.