Shandong Province, the second class of medical equipment business license for what procedures and documents required

Data No. 1, "Medical Device Business License Application Form" 2 copies, "Medical Device Business License" electronic declaration file. Data No. 2, the administration for industry and commerce issued by the "pre-approval notice of enterprise name" or "industrial and commercial business license" copy of the original and one copy.

Data No. 3, Application Report. (Including a description of the business personnel, scale of operation, scope of business, etc.)

Data No. 4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificates. (Note: such as the state of the medical equipment city tenants of the business enterprises need to provide unified warehousing and unified quality management organization related documents)

Data No. 5, business premises, warehouse layout plan.

Data No. 6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality management of the identity card, a copy of the certificate of academic qualifications or professional title certificate and personal resume.

Data No. 7, a list of technical staff and copies of academic and professional title certificates.

Data No. 8, a catalog of business quality management standardized documents, including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents;

Data No. 9, the enterprise has installed the product purchase, sale and inventory of information management system, print a copy of the home page of the information management system.

Data No. 10, storage facilities and equipment catalog.

Data No. 11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials 1, including the directory of application materials and materials made by the enterprise if the material is false to assume legal responsibility for the commitment;

Data No. 12, where the application for the enterprise to declare the materials, handle the personnel is not the legal representative or the person responsible for the person himself, the enterprise should be submitted to the "Authorized Power of Attorney" 1 copy.

Data No. 13, apply for a "medical device business enterprise license" confirmation ---------------- under each data number, there are other special requirements, in order to the provincial bureau of the medical device business administrative licensing acceptance criteria shall prevail.

Ozida medical device consulting organization