The use of medical devices is intended to achieve the following intended purposes:
1. Prevention, diagnosis, treatment, monitoring, and mitigation of disease.
2. Diagnosis, treatment, monitoring, alleviation, and compensation of injury or disability.
3. The study, substitution, regulation, or support of anatomical or physiological processes.
4. Support or maintenance of life.
5. Pregnancy control.
6. Providing information for medical or diagnostic purposes through the examination of samples from the human body.
The first category is medical devices that have a low level of risk and whose safety and effectiveness can be assured by routine management.
such as: surgical instruments (knives, scissors, pliers, tweezers, hooks), scraping boards, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze, bandages, drainage bags.
The second category is with moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
such as medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implantable materials, medical absorbable sutures, intravascular catheters and so on.