The specific content of the scope of business of Class III medical devices:
1, operating room equipment: including a series of instruments used in the operating room, such as operating tables, surgical chairs, operating room monitors, surgical instruments, anesthesia equipment, suction and defibrillators, etc.;
2, rehabilitation equipment: mainly refers to the rehabilitation of therapeutic equipment, such as physical therapy equipment, rehabilitation computers, rehabilitation chairs
3, therapeutic devices: mainly refers to clinical treatment of devices, such as ultrasound therapy, air therapy, heat therapy and electrotherapy instrument, etc.;
4, testing devices: mainly refers to clinical testing of devices, such as blood analyzers, immunoassay analyzers, flow cytometers, radioactivity detector, etc.;
5, nursing equipment: Mainly refers to the instruments for nursing, such as nursing beds, wheelchairs, nursing bed pillows, nursing chairs, nursing wheelchairs and so on.
In summary, the scope of business of Class III medical devices includes operating room devices, rehabilitation devices, therapeutic devices, testing devices and nursing devices.
Legal basis:
"Supervision and Administration of Medical Devices" Article 9
Engaged in medical device business activities, should have the following conditions:
(a) with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have the relevant professional qualifications or titles;
(B) with the scope and scale of operation of the business premises;
(C) with the scope and scale of operation of the storage conditions;
(D) with the operation of medical devices appropriate quality management system;
(E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service of the quality management organization or personnel.