Apply to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise is located or the (food) drug supervision and administration institution of the city divided into districts. The following materials shall be submitted when applying for the License of Medical Device Business Enterprise.
1. Application Form for Medical Device Business License.
2, issued by the administrative department for Industry and commerce enterprise name pre-approval documents.
3. A copy of the ID card, diploma or professional title certificate and resume of the enterprise quality management personnel to be employed.
4. Organization and functions of the proposed enterprise.
5. A copy of the geographical location map, floor plan (indicating the area) of the registered address and warehouse address of the proposed enterprise, and the house property certificate (or lease agreement).
6, the proposed enterprise product quality management system documents and storage facilities, equipment directory.
7. Business scope of the enterprise to be established.
What is the online filing process of the second-class pharmaceutical sales?
Online declaration process of Class II medical devices:
I. Materials to be submitted when applying for the business record of Class II medical devices:
1, business license;
2, the legal representative, the person in charge of the enterprise, the person in charge of the qualification certificate, education or professional title certificate;
3. Organization and department setting;
4. Description of business scope and mode of operation;
5. Geographical location map, floor plan, house title certificate or lease agreement of the business premises and warehouse address; (with real estate license)
6. Catalogue of operating facilities and equipment;
7, management of quality management system, working procedures and other file directory;
8. Encourage the use of computer information management systems;
9. The authorization certificate of the agent;
10, a scanned copy of the signed and sealed application form;
1 1, and other supporting materials.