Belongs to; including vascular interventional class, non-vascular interventional class.
High-value medical supplies for the safety of vital, production and use must be strictly controlled, limited to certain specialties and relatively high price of expendable medical devices.
The main categories are: vascular intervention involving: coronary arteries, structural heart disease, congenital heart disease, peripheral blood vessels, etc.; non-vascular intervention involving: trachea, digestive tract (esophagus, intestines, biliary tract, pancreas), bladder, rectum, etc.; orthopedic implantation involves: spinal column, joints, trauma, etc.; pacemakers involving: heart, bladder, etc.; extracorporeal circulation and blood purification; ophthalmic materials; Stomatology, etc.
Expanded Information:
Implantable device use requirements stipulate:
1, the state food and drug administration in accordance with the production, operation and use of medical devices, timely analysis of the risk of changes in medical devices, evaluation, and adjustments to the classification catalog of medical devices.
2, passive contact with the human body devices: according to the time limit for use is divided into temporary use, short-term use, long-term use; contact with the human body is divided into the part of the skin or cavity (mouth), trauma or tissues, the blood circulation system or the central nervous system.
3, the degree of risk of medical devices should be based on the intended purpose of the medical device, through the structural features, the use of form, use of state, whether contact with the human body and other factors.
Baidu Encyclopedia - Implantable Devices
Baidu Encyclopedia - Rules for Classification of Medical Devices