The state implements classified management of medical devices according to the degree of risk.
The first category is the low degree of risk. The implementation of routine management can ensure its safe and effective medical devices. Such as: surgical instruments (knife, scissors, forceps, tweezers, hooks), scraper plates, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms, etc. The third category is medical devices that have high risks and require special measures to strictly control management to ensure their safety and effectiveness. Such as: implantable cardiac pacemaker, contact lens, artificial lens, ultrasound tumor focusing knife, hemodialysis device, implant equipment, vascular stent, comprehensive anesthesia machine, dental implant material, medical absorbable suture thread, blood vessel Inner catheter, etc. Do medical devices need to be inspected and tested before they are approved for marketing?
The second and third types of medical devices need to be registered and tested at inspection and testing institutions recognized by the State Food and Drug Administration when applying for registration. The first type of medical device products are filed, and no clinical trial is required. When applying for the registration of Class II and Class III medical device products, clinical trials shall be conducted;
However, under any of the following circumstances, the clinical trial may be exempted:
(1) The working mechanism is clear, the design is stereotyped, the production process is mature, and the medical devices of the same variety that have been on the market have been in clinical use for many years without a record of serious adverse events, and do not change the routine use;
(2) It can be proved that the medical device is safe and effective through non-clinical evaluation;
(3) Analysis and evaluation of data obtained from clinical trials or clinical use of the same type of medical device can prove that the medical device is safe and effective.
The catalog of medical devices exempted from clinical trials shall be formulated, adjusted and published by the Food and Drug Administration of the State Council. What is the scope of application of medical device products? The scope of application of medical device products is generally approved by the Food and Drug Administration on the basis of clinical trials and must not be exaggerated or changed at will. Therefore, consumers should carefully check the product's scope of application, contraindications, precautions, etc. before purchasing to analyze whether the product is applicable.