Medical devices have three types of registration can not operate two types of products, a class of products can be operated, a class of products when the operation is not required to license and record.
According to the "supervision and management of medical devices business approach" Article IV in accordance with the degree of risk of medical devices, medical devices business implementation of classification management. Management of Class I medical devices do not require licensing and filing, the management of Class II medical devices for the record management, the management of Class III medical devices for licensing management.
Expanded information:
Medical Devices Business Supervision and Administration Measures p>"Supervision and Administration of Medical Devices" Article 8 engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district, and submit the following information:
(a) a copy of the business license and organization code certificate;
(b) legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge, Academic qualifications or certificates of title;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents of property rights of the house or lease agreement (with documents of property rights of the house) a copy of;
(F) business facilities, Equipment directory;
(vii) business quality management system, work procedures and other documents directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.
Baidu Encyclopedia - Medical Device Management Supervision and Administration