Enterprises based on the "Medical Device Manufacturer License" on-site review of the standard, the corresponding production implementation rules or production quality management standard requirements to prepare, log on to the Beijing Municipal Drug Administration enterprise service platform for online reporting, and according to the provisions of the scope of acceptance, the following application materials need to be submitted:
1, "medical device production Enterprise License (start-up) Application Form" 2 copies;
2, legal representative, the person in charge of the enterprise's identity, proof of education or title, a copy of the appointment documents and 2 copies of the work resume;
3, industrial and commercial administration issued a "business license" copy or "pre-approval of the enterprise name notification" original and 2 copies;
4, production Venue documents, including lease agreements, property certificates (or proof of right to use) 2 copies; factory location road map, the general layout of the factory, the main production workshop layout plan 2 copies, with clean workshop requirements, must be marked with the functional rooms and the direction of human and logistical flows;
5, the enterprise's production, technology, quality department responsible for the curriculum vitae, proof of academic qualifications or title 2 copies of the proof of the title; 2 copies of the relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; 2 copies of the ratio of senior, middle and junior technical personnel;
Compliance with the quality management system requirements of the internal auditor's certificate 2 copies (applicable to the third class of medical device manufacturers);
6, to be produced by a copy of the relevant product standards and a brief description of each of the 2 copies of the product, product description at least Including the structural composition of the product, principle, intended use of the description;
7, 2 copies of the list of major production equipment and testing instruments;
8, 2 copies of the production quality management specification document directory;
9, 2 copies of the proposed production of the product's process flow diagram, and indicate the main control items and control points, including the key and special processes of the equipment, personnel and process parameters to control the description;
9, the proposed production of products, and the main control items and control points, including the key and special procedures, equipment, personnel and process parameters control
10, the proposed production of sterile medical devices, you need to provide 2 copies of qualified test reports of the clean room, the test report should be issued by the provincial food and drug supervision and management department recognized testing organizations within one year in line with the "production of aseptic medical devices management norms" (YY0033) of the qualified test reports;
11, declaration of the authenticity of the material self Guarantee statement of 2, including the enterprise to the material to make a commitment to bear legal responsibility for any false;
12, where the application for the enterprise declaration of materials, the processing staff is not the legal representative or person in charge of himself, the enterprise should be submitted to the "power of attorney.
Duration: 2 working days
Two, review
Duration: 22 working days
Three, review
Duration: 3 working days
Four, validation
Five, administrative licensing decision
Six, delivery
Duration: 10 working days (for the period of delivery)