Chengdu Class II medical device business filing process

There are many companies engaged in the sale of medical equipment, which are engaged in the operation of Class II medical equipment business there are many. The state has provisions, engaged in the sale of Class II medical equipment business enterprises are required to the relevant departments for the record can be normal and legal business. However, the process is more complex, and many business friends are also the first time for the relevant process is not very clear, so many friends do not know how to handle.

Class II medical device means that the safety and effectiveness of medical devices should be controlled, must apply to the relevant departments of this case.

1, the second class of medical devices business filing form;

2, business facilities, equipment directory;

3, a copy of the business license;

4, organizational structure and departmental setup description;

5, the scope of business, the business mode description;

6, the legal representative, the person in charge of the enterprise, the person in charge of quality Proof of identity, education or title;

7, business premises, warehouse address of the geographic location of the map, floor plan, documents proving property rights or a copy of the lease certificate issued by the housing rental agency;

8, proof of authorization of the operator;

9, business quality management system, work procedures and other documents directory.

The above is about Chengdu for medical equipment class II registration certificate for the record the conditions and information required to prepare, if your conditions do not meet the standard or the information is not complete you can also find a tax company to help you do the whole process