Medical devices class I, II and III how to divide

The first class is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.

The second category is a medium risk, need to strictly control the management to ensure its 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.

Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.

The food and drug administration department under the state council is responsible for formulating the classification rules and classification directory 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 directory.

Development and adjustment of the classification directory, should fully listen to the medical device production and management enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice.

To engage in the production of medical devices, should have the following conditions:

1, with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel;

2, there is the production of medical devices for the quality of the institution or full-time inspectors and inspection equipment;

3, there is a medical device quality management system;

3, to ensure that the quality of medical devices;

4, there is a medical device quality management system;

4, there is a medical device quality management system. Medical device quality management system;

4, with the production of medical devices compatible with the after-sales service capabilities;

5, product development, production process documentation requirements.

References: