The filing of Class II medical devices does not require annual review. Based on the "supervision and management of the production of medical devices," Article XIII provides that the record license is valid for five years.
At the same time, according to the provisions of its Article XVII of the "Medical Device Manufacturing License" expiration of the continuation of the medical device manufacturers should be valid since the expiration of six months before the original licensing department for the continuation of the "Medical Device Manufacturing License" application.
The materials required for the filing of Class II medical devices:
1, the legal representative, the person in charge of the enterprise's basic information and proof of qualifications.
2, the administrative department for industry and commerce issued a notice of pre-approval of the proposed business name.
3, the production site to prove the text.
4, enterprise production, quality and technical personnel in charge of the resume, education or title certificate; relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; senior, intermediate and junior technical personnel ratio table.
5, the scope of products to be produced, varieties and related product profile.
6, the main production equipment and inspection equipment catalog.
7, production quality management documents catalog.
8, the process flow diagram of the proposed production products, and indicate the main control items and control points.
9, the production of sterile medical devices, should provide production environment test report.
The above references? Baidu Encyclopedia - Medical Device Production Supervision and Management Measures, Baidu Encyclopedia - Class II Medical Devices