1. Application Form for Renewal of Old Certificate of Medical Device Business Enterprise;

2. Original and photocopy of the business license issued by the administrative department for industry and commerce; (If it is an unincorporated enterprise, a copy of the corporate business license shall be submitted at the same time);

3. The original and photocopy of the Medical Device Business License;

4 quality management personnel's ID card, education or professional title certificate and its original copy and resume;

5. Organization and functions;

6. The geographical location map, floor plan (indicating the area and functional layout) of the registered address and warehouse address of the enterprise, and a copy of the certificate of the property right and the right to use the house;

Where an enterprise uses centralized storage to store products, it is required to submit the business license of the enterprise as a legal person, the License for Medical Device Business and the description of the establishment of centralized storage of the enterprise as a legal person (it is not necessary to submit the house property right, the right to use certificate and the location map and floor plan of the warehouse address).

7 enterprises engaged in in in vitro diagnostic reagents shall submit the following application materials at the same time:

(1) The academic credentials, photocopies and resumes of the legal representative and person-in-charge of the enterprise;

The original and photocopy of the qualification certificate and letter of appointment of licensed pharmacist;

(3) The original and photocopy of the certificate of the inspector-in-charge, the letter of appointment or the original and photocopy of the certificate of bachelor degree or above in inspection-related major, and the certificate that he has been engaged in inspection-related work for more than 3 years;

(4) Product scope;

⑤ Business premises, equipment, storage facilities and surrounding sanitary environment;

⑥ Enterprise quality management documents and storage facilities and equipment catalogue.

8. Apply for a self-assurance statement on the authenticity of the materials, and promise to bear legal responsibility for the falsehood of the materials;

9. If the applicant is not the legal representative or person in charge when the enterprise applies for the materials, the enterprise shall submit a power of attorney;

10. enterprise self-inspection report: including the punishment of the enterprise by the drug supervision department during the certificate-holding period, the unqualified sampling inspection of the operating products, the self-inspection and self-correction of the enterprise's operation quality management, and the implementation of rectification, etc.

Remarks: If the contents of the License for Medical Device Business Enterprises are changed during the renewal period, the Application Form for Renewal of the Old License for Medical Device Business Enterprises shall be filled out according to the changed contents, and the relevant materials required for the relevant change procedures and the description of the enterprise change shall be submitted according to the changed contents.

Details can be found in Freda official website.