I. Review and management authority: Enterprises that operate the second and third categories of medical devices are reported to the Provincial Drug Administration for approval and issued the "Medical Device Business Enterprise License".

1. Provincial enterprises (registered and registered by the Provincial Industry and Commerce Bureau) are directly accepted by the Provincial Drug Administration;

2. Other companies and enterprises shall be tried and reviewed by the drug supervision agencies of various urban areas. If the project is approved, the standards shall be reached.

2. Report materials:

1. 1 application;

2. Fill in the "Medical Device Operation Enterprise License" application form in 3 (the film's failure);

3. The company's (enterprise) regulations and the new settlement report (renewal to the company's financial statements and profit forms) each;

4. 1 copy of the company's self -correction and self -correction (comparison of the "Implementation Rules for the Implementation of the Qualification Approval of the Guangdong Provincial Medical Device Management Enterprise" and the "Guangdong Provincial Nuclear Nuclear, Replacement and Acceptance Standards");

5. List of technical, maintenance personnel, and 1 shadow of graduation certificates and professional qualification certificates (stamped with the official seal of the company);

6. Operation, warehousing logistics venue house property right certificate or leasing collaboration and total flat plan;

7. The detailed written form of the Municipal Drug Administration reviews the completion and acceptance report of the completion and acceptance report (other than the provincial enterprise);

8. The company name of the Industry and Commerce Bureau's pre -registered registration is confirmed or the "legal person business license" group is printed;