Chapter I General Principles
Article 1 In order to strengthen the supervision and management of medical device business, standardize the operation of medical devices, to ensure the safety and effectiveness of medical devices, according to the "Supervision and Administration of Medical Devices Regulations", the development of these measures.
The second in the Chinese people *** and the country engaged in medical equipment business activities and its supervision and management, shall comply with these measures.
Article 3 The State Food and Drug Administration is responsible for the supervision and management 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 equipment business in the administrative region.
Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of medical devices.
Article IV According to the degree of risk of medical devices, medical devices 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.
Article V The State Food and Drug Administration to develop quality management standards for the operation of medical devices and supervise the implementation.
Article VI of the Food and Drug Administration in accordance with the law and timely release of medical device license and filing information. Applicants can inquire about the progress of approval and approval results, and the public can access the approval results.