1, office area of not less than 40 square feet; (business building or storefront store);
2, the warehouse area of not less than 15 square feet; (my company can provide) (three types of in vitro diagnostic reagents containing a time the need for frozen warehouses);
3, including three types of disposable supplies, then the requirements of the office address and warehouse area together can not be less than 160 square feet;
If the warehouse entrusted to a third-party logistics company, you need to have a medical device license qualification logistics company can be. and warehouse area together can not be less than 160 square feet;
If the warehouse entrusted to a third-party logistics company, you need to have a medical device license qualification of the logistics company can be.
For the second class of medical devices business filing personnel requirements:
1, with medical equipment, medicine, pharmacy bachelor's degree or above, or intermediate or above technical title 1, as the quality responsible for
2, with high school education or above, as the quality of the administrator;
Medical device business filing vouchers required for the application materials:
Medical device business filing vouchers:
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1. Class II medical device business filing form
2. Business license and a copy of the organization code certificate
3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person, a copy of the certificate of academic qualifications or titles
4. Organizational and departmental setup instructions
5. Scope of business, the business mode of operation description;
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6. business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or a copy of the lease certificate issued by the housing leasing office;
7. business facilities, equipment directory;
8. business quality management system, work procedures and other documents directory;
9. proof of authorization by the operator.