The first class is a low degree of risk, the implementation of routine management can ensure its safety, effective medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), gua sha board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on.
Surgical instruments belong to the first class of medical devices
The second class is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. For example, medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
Familiar mercury sphygmomanometer belongs to the second class of medical devices
The third class is a higher risk, need to take special measures to strictly control the management to ensure its 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 implant materials, medical absorbable sutures, intravascular catheters and so on.
Several types of implantable medical devices
It can be seen that the country has a strict classification of medical devices, and Class III medical devices are the highest level of medical devices, but also must be strictly controlled medical devices, refers to the implantation of the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices" Article 6 The state implements classification and management of medical devices according to the degree of risk. The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors. The drug supervision and management department of the State Council is responsible for formulating the classification rules and classification catalog of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalog. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory should be published to the community.