Legal analysis:
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 name of the proposed enterprise;
3, the enterprise production, quality and technical personnel in charge of the curriculum vitae, academic qualifications or title certificates; the relevant professionals and technicians, skilled workers registration form, and indicate their departments and Positions; senior, intermediate, junior technical staff ratio table;
4, the scope of products to be produced, varieties and related product profile; production site documents
5, the main production equipment and inspection equipment catalog;
6, the production of products to be produced in the process flow diagram, and indicate the main control items and control points;
7, the production of sterile Medical devices, should provide production environment test report.
Legal basis: "supervision and management of medical devices regulations"
Article 29 engaged in the operation of medical devices, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 30 of the provisions of the second class of medical devices engaged in the business, by the business enterprise to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit it to meet the conditions of Article 29 of the Ordinance to prove the information.