Medical equipment Class II filing process:
1. Enter the Market Supervision Bureau Class II medical device office platform to view all the processing details.
2. Use the account of the legal person to log in, because it is necessary to associate to the enterprise information in order to normalize the process.
3. Audit can be issued through the second class of medical record certificate, print it out on your own.
Legal Objective:"Supervision and Administration of Medical Devices" Article 3
The State Food and Drug Administration is responsible for the supervision and administration of the national medical device business. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of medical device business in the administrative area.
The higher-level food and drug supervision and management departments are responsible for guiding and supervising the lower-level food and drug supervision and management departments to carry out supervision and management of medical devices.
Article 4
In accordance with the degree of risk of medical devices, medical device business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.