The definition of medical device in Chapter VIII Supplementary Provisions of the Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council of the People’s Republic of China) refers to the instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other materials that are directly or indirectly used in the human body. Similar or related items, including required computer software.
The use of medical devices is intended to achieve the following intended purposes:
- Prevention, diagnosis, treatment, monitoring and mitigation of diseases.
- Diagnosis, treatment, monitoring, mitigation, compensation for injury or disability.
- The study, substitution, modulation or support of anatomical or physiological processes.
- Support or maintenance of life.
- Pregnancy control.
- Provides information for medical or diagnostic purposes by examining samples from the human body.