1, the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices and the laws, rules and regulations and related product quality, technology, quality of the person in charge shall not be concurrently in charge of the production;
2, the enterprise above junior title or technical personnel with secondary education or more than the proportion of the total number of employees should be compatible with the requirements of the production of products
3, the enterprise should have with the production of products and production scale of production equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, etc., should be consistent with national standards, industry standards and relevant state regulations;
4, the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;
5, the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations and relevant Technical standards;
6, the relevant professional title above the intermediate level or college degree or above full-time technical personnel (the third production enterprises, in vitro diagnostic reagents should be not less than two,);
7, in line with the requirements of the quality management system (ISO13485 training) internal auditors (the third category of manufacturers, the second category of manufacturers, the production of in vitro diagnostic reagents production enterprises at least two, namely 1 management representative, 1 internal auditor)
8, the production of products belonging to the state has promulgated the production of medical devices quality standards (on the issuance of medical device production quality management standards.doc) (including the production of implementation rules) must comply with the requirements of its specifications (production implementation rules).
Second, the applicant to submit materials directory:
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 resume;
Data No. 3, the business administration Department issued a "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 proof of real estate or lease agreement and a copy of the lessor's real estate certificate 1 copy; the general layout of the plant, the main production workshop layout 1 copy, there are clean requirements of the workshop, the function of the room shall be marked and the flow of people to the direction of the flow of people; "the". Class II, Class III medical device manufacturers to set up production sites across the province registration form" 4 (to set up production sites across the province of the enterprise applies);
Data No. 5, the enterprise's production, technology, quality department responsible for the curriculum vitae, a copy of proof of academic qualifications or titles; relevant professional and technical personnel, skilled workers registration form 1; related personnel registration form 1 (in the application form) Download), 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 products to be produced, the variety of products and related product profile 1 copy (product profile at least includes the structural composition of the product, principles, intended use of the description and product standards); to produce in vitro Diagnostic reagents, you also need to provide the production of in vitro diagnostic reagents, a list of enterprises, see Schedule 1;
Data No. 7, a list of the main production equipment and testing instruments;
Data No. 8, a catalog of production quality management standardized documents, including purchasing, acceptance, the production process, product testing, warehousing, storage, quality tracking, user feedback, monitoring and quality incident reporting system and other documents. Monitoring and quality incident 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 processes, equipment, personnel and process parameters control instructions;
Data No. 10, the production process has purification requirements should be provided to the provincial food and drug supervision and management authorities recognized by the testing agency issued a copy of the environmental test report within one year. A copy of the environmental testing report within one year (including: a production area purification workshop test report, a 10,000 purification bacteriological inspection room test report).
The environment of the proposed production of sterile medical devices should meet the requirements of YY0033 "Management Standards for the Production of Sterile Medical Devices";
The environment of the proposed production of in vitro diagnostic reagents should meet the requirements of Appendix A of the "In Vitro Diagnostic Reagent Production Regulations (for trial implementation)".
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.
Third, the requirements of the application materials:
(a) the general requirements of the declaration of information:
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, it must be signed or signed by the legal representative.