The use of medical devices aims to achieve the following expected purposes:
1. Prevention, diagnosis, treatment, monitoring and mitigation of diseases.
2. Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability.
3. Research, substitution, adjustment or support of anatomical or physiological processes.
4. Support or maintain life.
5. Pregnancy control.
6. To provide information for medical or diagnostic purposes by examining human samples.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
Such as: surgical instruments (knives, scissors, pliers, hooks), scraping plates, medical X-rays, surgical gowns, surgical caps, examination gloves, gauze, bandages, drainage bags, etc.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
Such as medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, absorbable suture, condom, etc.
The third category is medical devices with high risks, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
Such as implantable pacemakers, contact lenses, intraocular lenses, ultrasonic tumor focusing knives, hemodialysis devices, implant devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters and the like.