The process of handling medical devices is tedious and complicated. The types of medical devices are divided into three categories. Different types of medical device licenses are handled in different ways. We have to go according to their own needs to correspond to the processing, do a good job of preparation, in order to efficiently and smoothly for success. The following is a small introduction to you about the medical device class II record for the materials needed.
A, medical equipment class II record for what materials
1, business license and organization code certificate copy, (if the company is not yet registered on the company registration process, do a good company license and then do the second class of medical equipment business record vouchers can be).
2, the legal representative, the person in charge of the enterprise, the person in charge of quality of the Ming, education or title certificates, (conditions are not met, it's okay, looking for into the benefits of refinement).
3, organizational structure and departmental setup description, (if not, please contact us).
4, business scope, business mode description, (if not, please contact us).
5, business premises, warehouse address of the geographic map, floor plan, documents proving ownership of housing or lease agreement (with documents proving ownership of housing) copies, (if not, please contact us).
6, business facilities, equipment catalog.
7, business quality management system, work procedures and other documents catalog.
8. Proof of authorization of the operator.
9, other supporting materials.