Class III medical device business scope

The business scope of Class III medical devices generally includes medical device sales, medical device repair, medical device research and development, medical device production, etc., and also need to go through a strict approval and registration process.

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, refers to the implantation of the human body, used to support, maintain life, the safety and effectiveness of which must be strictly controlled medical devices.

The specific contents of the business scope of Class III medical devices:

1, operating room instruments: including a series of instruments used in the operating room, such as operating tables, surgical chairs, operating room monitors, surgical instruments, anesthesia instruments, suction and defibrillators, etc.;

2, rehabilitation equipment: mainly refers to the rehabilitation of therapeutic instruments, 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 instruments, rehabilitation devices, therapeutic devices, testing devices and nursing devices.

Legal basis:

"Supervision and Administration of Medical Devices"

Article 9

Engaged in the medical device business activities, shall 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 the medical device quality management system;

(E) with the operation of the medical device appropriate professional guidance, technical training and after-sales service of the quality management body Or personnel.