Medical device license application materials, please page by page stamp or by the legal representative or the person in charge of the enterprise signature; materials please use the tie rod folder neatly bound.
For the second class of medical equipment business registration address requirements:
1, office area of not less than 40 square feet; (commercial buildings or storefront store);
2, warehouse area of not less than 15 square feet; (our company can provide) (three types of in vitro diagnostic reagents containing a single need for frozen warehouses);
3, including three types of disposable supplies, if the request 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 license qualification of the logistics company can.
For the second class of medical devices business filing personnel requirements:
1, with a medical device, medicine, pharmacy bachelor's degree or above, or intermediate or above technical title personnel 1, as the quality of responsible
2, with a high school diploma or above 2, as the quality of administrators;
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 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;
5.
6. business premises, warehouse address geographic location map, floor plan, documents proving ownership of the house or a copy of the lease certificate issued by the housing lease;
7. business facilities, equipment directory;
8. business quality management system, work procedures and other documents directory;
9. proof of authorization by the operator.