How to apply for the record of second-class medical devices?
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, 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 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 2, as quality manager;
Medical device business filing vouchers required for the application materials:
Medical device business filing vouchers:
1. /p>
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;
6. p>
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.