Medical device class II license application

The Class II medical device license is to operate the second class of medical devices, business enterprises need to the local food and drug regulatory departments for the record. Many companies may not understand how to deal with it, the following to you to organize the second class medical device license how to deal with and the application process and the materials required in the content of the introduction, you need to deal with the business can understand.

Class II medical device license how to handle

(a) Class II medical device license application for the actual steps:

1, the enterprise to the drug supervision department to submit a medical device license declaration.

2, the drug supervision department to review the material.

3, the enterprise submitted materials formally accepted.

4, the relevant departments of administrative review.

5, on-site review.

6, the relevant departments to make administrative decisions.

7, making and issuing certificates.

(B) Class II medical device license application required required materials

1, a copy of the business license;

2, the legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity, education or title certificate copy;

3, organizational structure and departmental setup description;

4, the scope of business, the business mode of operation description;

5, the business premises, warehouse address Geographic location of the map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies;

6, business facilities, equipment directory;

7, business quality management system, work procedures and other documents directory;

8, computer information management system basic information and functional description;

9, proof of authorization of the operator;

10, Application form

11, other supporting materials