The state of medical devices in accordance with the degree of risk to implement classification management.
Class I is a low-risk, routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the 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 making adjustments to the classification directory.
Development and adjustment of the classification directory, should fully listen to the medical device production and operation of enterprises, as well as the use of units, industry organizations, and reference to the international practice of classification of medical devices. Classification catalog of medical devices shall be published to the community.
Expanded Information
Engaged in the production of medical devices, should have the following conditions:
(a) with the production of medical devices appropriate production sites, environmental conditions, production equipment and professional and technical personnel;
(b) have the production of medical devices to carry out quality inspection of the organization Or full-time inspectors and inspection equipment;
(C) have to ensure 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.
Engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit its compliance with the conditions set out in the regulations to prove the information.
Baidu Encyclopedia - Chinese People's Republic of China **** and the State Council Decree (No. 680)