①A copy of the registration certificate of the product to be operated;
②Storage equipment, facilities directory;
③Change of scope of business at the same time need to be in accordance with the "Beijing Medical Device Business Inspection Acceptance Criteria", "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Acceptance Criteria" to increase the warehouse, you need to submit proof of property rights in a warehouse or lease agreement and the original and a copy of the warehouse address geographic location map, floor plan (indicating the area, functional layout). The original and a copy of the agreement and the warehouse address geographic location map, floor plan (indicating the area, functional layout);
4 change the scope of business at the same time need to "Beijing Medical Device Business Inspection and Acceptance Criteria", "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Acceptance Criteria" to increase the quality of management personnel, the need to submit proof of quality management personnel's identity, academic certification or title certificate Original and copy and personal resume; increase the operation of in vitro diagnostic reagents should be submitted at the same time the licensed pharmacist qualification, the supervisor of the inspector's certificate, the original and a copy of the letter of appointment, or test related professional college education certificate or the original, a copy of the certificate and engaged in testing related work for more than 3 years of work experience; enterprises should also be submitted to the change of personnel appointment and removal of personnel decisions or resolutions of the Board of Directors;
⑤ Increase in the operation of in vitro Diagnostic reagents should also be submitted to the enterprise: a. Legal representative of the enterprise, the person in charge of the enterprise's original academic certificate, a copy and biography; b, the enterprise registered address of the geographic location map, floor plan (indicating the area, functional layout), proof of ownership of the house (or lease agreement) original and copy. c, business premises, equipment, storage facilities and the surrounding health environment and other circumstances;