For the second class of medical equipment business filing registered address requirements:
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 single need for frozen warehouses);
3, containing three types of disposable supplies, then require Office address and warehouse area together can not be less than 160 square feet;
If the warehouse entrusted to a third-party logistics company need to have a medical device license. p>3, containing three types of disposables, then the requirements of the office address and warehouse area together can not be less than 160 square feet;
If the warehousing entrusted to a third-party logistics company, you need to have a medical device licensing qualification of the logistics company can be.
For the second class of medical equipment business record personnel requirements:
1, with medical equipment, medicine, pharmacy professional bachelor's degree or above or intermediate or above technical title, as the quality responsible for
2, with high school education or above 2, as the quality of the administrator;
The first two of these requirements are the following strong>?
Please medical device business filing certificate required application materials:
1. Class II medical device business filing form
2. A copy of the business license and organization code certificate
3. Legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge, Academic or professional title certificates
4. organization and departmental setup
5. business scope, business mode description;
6. business premises, warehouse address geographic location map, floor plan, documents proving ownership of the house or by the housing rental issued by the lease certificate copy;
7. business facilities, equipment directory;
8. Business quality management system, labor