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Materials required to change the scope of business of medical devices
"Medical Device Business License" original, copy of the original and a copy of 1 (original original (collected) 1, the original copy (collected) 1, a copy of 1)
2 . If the change of business name, should be submitted: the administrative department for industry and commerce issued a "notice of approval of change of business name" and has changed the "business license" copy of the original and a copy (the original copy (verified) 1, a copy of 1)
3 . Medical Device Business License Change Application Form" 2 copies (1 copy)
4. Such as changes in the legal representative of the enterprise, should be submitted: proof of identity of the legal representative, proof of academic qualifications or professional title, work resume 1, has changed the "business license" copy of the original and a copy; (1 copy)
5 . If you change the address of the warehouse, you need to provide the warehouse floor plan, proof of ownership or use of housing (Note: According to "Guangzhou Housing Lease Management Regulations" (Guangzhou Municipal People's Government Decree No. 29), the lease agreement is required to be in the local streets, town rental housing management service center for lease registration), geographic location map, the inventory of warehouse facilities and equipment (1 copy)
6 . Application for "Medical Device Business License" confirmation (original original (collected) 1)
7. Letter of Authorization (original (collect) 1 copy)
8 . Business License" copy of the original and a copy (original copy (verification) 1, 1 copy)
9 . Quality manager's ID card, a copy of the certificate of education or title certificate and resume. On-the-job in-service documents (labor contract, personal social security contributions in this enterprise). (1 copy)
10 . If you change the person in charge of the enterprise, you should submit: proof of identity of the person in charge of the enterprise, proof of academic qualifications or title, a copy of the appointment document and a copy of work resume (1 copy)
11 . Such as changes in business registration (business) address, you need to provide business premises layout plan, proof of property rights or use of housing (Note: According to "Guangzhou Housing Lease Management Regulations" (Guangzhou Municipal People's Government Decree No. 29), the lease agreement needs to be in the local streets, towns, rental housing management service center for lease registration), geographical location map (1 copy)
12 . If you change the scope of business, you need to provide a copy of the layout of the warehouse, property certificates or lease agreements and the site of the property certificates, warehouse facilities and equipment directory and the corresponding storage conditions, quality manager's academic qualifications or certificates of title, a list of professional and technical personnel and personnel qualifications, titles, certificates, copies of identity cards and certificates of registration of the products to be operated and a description of the corresponding storage conditions. (The information required in this item need not be provided if the scope of reduction is reduced.) (1 copy)
13 . Quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials 1, including the catalog of application materials and the enterprise on the materials to make if false to assume legal responsibility for the commitment (original original (collected) 1)
14 . If you change the quality management, you need to provide the proposed quality management education, title certificate, ID card copies and "enterprise quality management personnel resume. (Enterprises operating Class B products, you need to provide quality management personnel have worked in medical institutions, licensed medical practitioner's license or have worked in a medical institution to purchase social security documents) (copy 1)
15 . Business to change the content of the information (original original (received) 1)
16 . If the operation of in vitro diagnostic reagents, you need to provide proof of the relevant cold chain facilities. Such as standby generator sets or standby refrigeration units, automatic temperature controllers, automatic alarm equipment, refrigerated trucks and other invoices or instructions on the use of cold storage installation contracts, certificates of compliance with the operation or instructions on the use of cold storage. (1 copy)