Data No. 1, "Medical Device Manufacturer License (start-up) Application Form" 3;
Data No. 2, legal representative, the person in charge of the enterprise's identity, proof of academic qualifications or title, a copy of the appointment document and a copy of the work experience;
Data No. 3, issued by the administrative department of industry and commerce, "the Notice of pre-approval of enterprise name" or "industrial and commercial business license" copy of the original and 1 copy;
Data No. 4, the production site documents, including property certificates or lease agreements and a copy of the lessor's property certificates; the general layout of the plant, the main production plant layout 1, there are clean workshop requirements, shall be marked with the function of the inter-room and people flow towards; "the second, third type of Medical Device Manufacturing Enterprises Setting up Production Sites Across Provinces" 4 copies (applicable to enterprises intending to set up production sites across provinces);
Data No. 5: 1 copy of the resume, academic certificate or title certificate of the person in charge of the production, technology and quality departments of the enterprise; 1 copy of the registration form of the relevant professional and technical personnel and technical workers; 1 copy of the registration list of the relevant personnel (download in the application form area), and indicate the department and position; 1 copy of the registration form of the relevant personnel (download in the application form area), and the registration list of the relevant personnel (download in the application form area), and Indicate the department and position; 1 copy of the ratio of senior, middle and junior technical personnel; 1 copy of the internal auditor's certificate in line with the requirements of the quality management system;
Data No. 6, the scope of the products to be produced, varieties and related products, each 1 copy of the brief (the product profile at least includes a description of the structural composition of the product, the principle of the intended use, and the standard of the product); the production of in vitro diagnostic reagents are proposed, it is also necessary to provide the proposed production of in vitro diagnostic reagents. In vitro diagnostic reagents, also need to provide the production of in vitro diagnostic reagents, a list of enterprises, see Schedule 1;
Data No. 7, a list of major production equipment and testing instruments;
Data No. 8, a catalog of production and quality management standardized documents, including purchasing, acceptance, the production process, product testing, warehousing, warehousing, quality tracking, feedback from the user, monitoring of adverse events and quality incident reporting system. Reporting system and other documents;
Data No. 9, to produce a product process flow diagram, and indicate the main control items and control points, including key and special process equipment, personnel and process parameters control instructions;
Data No. 10, the production process has purification requirements should be provided with provincial food and drug supervision and management authorities recognized by the testing organization (such as: Jiangsu Province) Quality Supervision and Inspection of Medical Devices, Jiangsu Provincial Drug Inspection Institute, etc.) issued within one year, a copy of the environmental testing report (including: a production area purification workshop test report, a 10,000 purification bacteria inspection room test report).
Such as the proposed production of sterile medical devices, the environment should meet the requirements of YY0033 "sterile medical device production management norms";
such as the proposed production of in vitro diagnostic reagents, the environment should meet the "in vitro diagnostic reagent production implementation rules (for trial implementation)," the requirements of Appendix A.
Data No. 11, a self-assurance statement of the authenticity of the application materials, including the catalog of application materials and the enterprise to make the material if false to assume legal responsibility for the commitment;
Data No. 12, where the application for the enterprise declaration of the material, the processing personnel is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney".
Data No. 13, truthfully filled out to start a medical device manufacturing enterprise self-examination confirmation of 1, apply for inspection confirmation of 1.
Requirements for the application materials:
1, the application materials should be complete, clear, signed and stamped with the official seal of the enterprise one by one, if there is no official seal, there must be a legal representative of the signature or signature. Printed or copied on both sides of A4 paper, and bound in a book in accordance with the order of the catalog of application materials;
2. Where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy "this copy and the original in line with the" or text description, date, and stamp the official seal of the unit; personal application shall be signed or signed;
3. Signature;
(B) the specific requirements of the reporting information:
1, the production enterprise to submit the "Medical Device Manufacturer License (start-up) Application Form", "Class II, Class III Medical Device Manufacturer to set up production sites across the province registration form" (if any) should be signed by the legal representative and stamped with the official seal of the enterprise (if any);
2, the "medical device manufacturing Enterprise License (start-up) Application Form", "Class II, Class III Medical Device Manufacturing Enterprises across the province to set up production site registration form" (if any) the items filled in should be filled out completely and accurately, fill in the content should be consistent with the following requirements:
"Enterprise name", "registered address "and" industrial and commercial business license "or" pre-approved notice of enterprise name "is the same;" "scope of production" in line with the provisions of the second category, the third category of product management category;
3, the legal representative of the identity card, proof of academic title, appointment documents should be valid;
4, the administrative department for industry and commerce issued a "notice of pre-approval of enterprise name" or "industrial and commercial business license" copy should be the same as the original, a copy of the confirmation of retention, the original is returned;
5, real estate certificates, proof of rental of housing (the lessor to provide proof of property rights) should be valid;
6, enterprise production, quality and technical personnel responsible for the curriculum vitae, proof of academic qualifications or professional title certificate Should be valid;
7, the production of quality management standardized document catalog, mainly should include procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, monitoring of adverse events and quality incident reporting system and other documents;
8, medical device production environment test report should be valid;
9, the authenticity of the application materials, the self-assurance statement It should be signed by the legal representative and stamped with the official seal of the enterprise, if there is no official seal, then the legal representative must sign or sign.
The process is as follows:
1, submission of information, 2, formal review, 3, project acceptance, 4, administrative review, 5, on-site inspection, 6, administrative approval, 7, certificate preparation and completion, 8, inform, issue a license.