What are the Medical Device Classification Standards and Methods?

In my country, medical devices are classified and managed according to the safety of medical device products.

The classification catalog is formulated by the State Food and Drug Administration in accordance with the medical device classification rules:

The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management. Such as surgical instruments (knives, scissors, forceps, forceps, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze, bandages, drainage bags, etc.

The second category is a medical device with the moderate risk that requires strict control and management to ensure its safety and effectiveness. Such as medical suture needles, sphygmomanometers, thermometers, electrocardiographs, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, etc.

The third category is medical devices with higher risks that require special measures to be strictly controlled and managed to ensure their safety and effectiveness. Such as implantable cardiac pacemakers, corneal contact lenses, intraocular lenses, ultrasonic tumor focusing knives, hemodialysis devices, implanted equipment, vascular stent, comprehensive anesthesia machine, dental implant material, medical absorbable sutures, blood vessel Inner catheters, etc.

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