Medical device business license requires the following information:
Data No. 1, "Medical Device Business License Application Form"
Data No. 2, "Pre-approval of the enterprise name notice"
Data No. 3, Guangdong Province, the medical device business enterprise (Wholesale) Self-examination Form
Data No. 4, business premises, warehouse premises plan and supporting documents
Data No. 5, a copy of the identity card of the legal representative of the proposed enterprise.
Data No. 6, a copy of the identity card of the person in charge of the proposed enterprise, quality manager, proof of education or title and personal resume.
Data No. 7, list of technicians and copies of certificates of education and professional titles.
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 been installed in the product purchasing, sales and inventory of the information management system, print the first 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 person in charge of himself, the enterprise should be submitted to the "Authorized Power of Attorney" 1 copy.
Data No. 13, applying for a "medical device business license" confirmation letter
Our company can help operating companies for medical device business license
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