Are Class II medical devices licensed, monopolized or restricted?

Hello, Class II medical devices are not exclusive, exclusive or restricted items. As long as your business license and medical device business record have this scope, you can sell them.

Application and acceptance

The applicant shall submit the following application materials (documents and articles) to the market supervision bureau window of the municipal administrative service center:

1. Operation Record Form of Class II Medical Devices (see Appendix B for examples);

2. A copy of the business license of the enterprise;

3 copies of the identity, education and professional title certificates of the legal representative or person in charge of the enterprise and the person in charge of quality;

4. Description of the organization and department of the enterprise;

5. A copy of the geographical location map, floor plan (indicating the actual use area), house title certificate or lease agreement (with house title certificate attached) of the business address and warehouse address of the enterprise;

6. Catalogue of business facilities and equipment;

7 enterprise management quality management system, working procedures and other documents and texts;

8. The authorization certificate of the agent;

9. Other supporting materials. The filing materials shall be complete and clear, printed and bound with A4 paper and attached with the table of contents, and the copies shall be submitted together with the electronic version after being stamped with the official seal.

The window shall review the application materials and check whether the application materials are complete and conform to the statutory form:

1: If the application matters are not within the authority of the department according to law, it shall immediately make a decision of rejection, issue a notice of rejection stamped with the special seal of the department and dated, and inform the applicant to apply to the relevant administrative organ;

2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

3. If the application materials are incomplete or do not meet the requirements of formal examination, a Notice of Supplementary Materials shall be issued to the applicant on the spot to inform the applicant of all the contents that need to be supplemented at one time;

4. If the application materials are complete and meet the requirements of formal examination, or the applicant submits all the corrected application materials as required, it shall be accepted, and an acceptance notice stamped with the special seal of the department and dated shall be issued.