Cosmetic Therapy Instrument is a medical device.
The state of medical devices in accordance with the degree of risk of the implementation of classification management.
1, the first class is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
2, the second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
3, the third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Expanded:
Engaged in the production of medical devices, should have the following conditions:
(a) with the production of medical devices suitable for the production site, environmental conditions, production equipment, as well as professional and technical personnel;
(b) there is the production of medical devices for the quality of the institution or full-time inspectors As well as inspection equipment;
(C) have to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) product development, production process documentation requirements.
Baidu Encyclopedia - Beauty Therapeutic Instrument
Baidu Encyclopedia - Medical Device