Legal analysis: Units or individuals engaged in the development, production, operation, use, supervision and management of medical devices shall abide by these regulations.
Legal basis: "Regulations on the Supervision and Administration of Medical Devices"
Article 2: Engage in the development, production, operation, use, supervision and management of medical devices within the territory of the People's Republic of China Units or individuals shall abide by these regulations.
Article 3 Medical devices as mentioned in these regulations refer to instruments, equipment, appliances, materials or other items used alone or in combination on the human body, including the required software; they are used on the human body surface and The effect in the body is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a certain auxiliary role; its use is intended to achieve the following expected purposes:
(1) Treatment of diseases Prevention, diagnosis, treatment, monitoring, and alleviation;
(2) Diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability;
(3) Anatomical or physiological processes Research, substitution and regulation;
(4) Pregnancy control.