Production of medical devices need to do the formalities are: the production of Class I medical device enterprises, need to be located in the municipal food and drug supervision and management department for the production of the record, and at the same time for the product filing; the production of Class II medical device enterprises need to be located in the provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department for the production of licenses, need to be simultaneously applied for Product registration and so on.
Legal Objective:"Regulations for the Supervision and Administration of Medical Devices"
Article 6
The state implements the classification and management of medical devices according to the degree of risk. The first category is a low degree of risk, the implementation of 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. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors. The drug supervision and management department of the State Council is responsible for formulating the classification rules and classification catalog 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 rules and classification catalog. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrants, filers, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice.