Chapter VIII of the regulations on the supervision administration of medical devices (Order No. 650 of the State Council of the people's Republic of China) defines Chinese medical devices as the instruments, equipment, instruments, in vitro diagnostic reagents calibrators, materials other similar related articles directly indirectly used for human body, including the required computer software.

The use of medical devices aims to achieve the following expected purposes:

1. Prevention, diagnosis, treatment, monitoring alleviation of diseases.

2. Diagnosis, treatment, monitoring, mitigation compensation of injury disability.

3. Research, replacement, regulation support of anatomical physiological processes.

4. Support sustain life.

5. Pregnancy control.

6. Provide information for medical diagnostic purposes by examining samples the human body.

What are the classification standards methods of medical devices?

According to the safety of medical devices, the medical devices are classified managed in China.

1. The first type is a kind of medical device with low risk, which can be guaranteed to be safe effective by routine management. Such as: surgical instruments (knife, scissors, forceps, tweezers, hooks), scraping plate, medical X-ray film, surgical clothes, surgical caps, inspection gloves, gauze, bandages, drainage bags, etc.

2. The second type is a kind of medical device with moderate risk, which needs strict control management to ensure its safety effectiveness. Such as medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non absorbable suture, etc.

3. The third category is the medical devices with high risk need to take special measures to strictly control manage to ensure their safety effectiveness. Such as: implantable pacemaker, corneal contact lens, intraocular lens, ultrasound tumor focusing knife, hemodialysis device, implantable equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc.

Text source / website of National Drug Administration