Legal analysis: the drug supervision and management department of the state council is responsible for the supervision and management of medical devices across the country. The drug supervision and management department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative area.
Legal basis: "supervision and management of medical devices regulations"
Article 3 The medical devices referred to in these regulations, refers to the use of the human body alone or in combination with instruments, equipment, appliances, materials, or other items, including the required software; its use in the human body surface and in vivo is not obtained by means of pharmacology, immunology, or metabolism, but there may be participation in these means and play a certain role in supporting; its use on the human body surface and in vivo is not obtained by pharmacology, immunology, or metabolism, but may have these means of participation and (ii) Diagnosis, treatment, monitoring, mitigation, compensation for injury or disability;
(iii) Study, substitution, regulation of anatomical or physiological processes;
(iv) Pregnancy control.
Article 4 The Drug Administration under the State Council is responsible for the supervision and management of medical devices throughout the country. The drug supervision and management department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative area. Drug supervision and management department of the State Council shall cooperate with the State Council comprehensive economic management department, the implementation of national medical equipment industrial policy.