1. "Medical Device Business License Application Form for Old License for New License";
2. "Business License" issued by the administrative department for industry and commerce, the original and a copy of the "business license"; (if an unincorporated enterprise, while submitting a copy of the legal person's business license);
3. "Medical Device Business License" original, Copies of the original and copies;
4. quality management personnel ID card, academic or professional title certificate and copies of the original and resume;
5. organization and function;
6. registered address, warehouse address of the geographic location of the map, the floor plan (indicating the area, the layout of the function) and the property rights of the house and the right to use a copy of the certificate;
Enterprises to take a centralized warehouse to store products, need to submit the corporate "business license", "Medical Device Business License" and its corporate centralized warehouse instructions (can no longer submit the warehouse house ownership, use of the right to certify the warehouse address and the buried location map and floor plan).
7. In vitro diagnostic reagents business enterprises should also submit the following application materials:
① legal representative of the enterprise, the person in charge of the original certificate of education, a copy and biography;
② licensed pharmacist qualification certificates and the original letter of appointment, a copy of the letter;
③ supervisor of the certificate of inspection, the original letter of appointment, and a copy of the original certificate of appointment or inspection of the relevant college professional Above the original academic certificate, a copy of the certificate and engaged in testing related work for more than 3 years of work experience certificate;
④ business scope of products;
⑤ business premises, equipment, storage facilities and the surrounding health environment and so on;
⑥ enterprise quality management documents and storage facilities, equipment directory.
8. Self-assurance statement of the authenticity of the application materials, and materials to make a commitment to bear legal responsibility for any false;
9. Where the application for the enterprise declaration of materials, the applicant is not the legal representative or the person in charge of the person, the enterprise should be submitted to the "letter of authorization";
10. Self-inspection report of the enterprise: including enterprises licensed during the period of the drug regulatory authorities by the punishment situation The report includes the situation that the enterprise has been penalized by the drug administration department during the period of license, the situation that the operating products failed in the sampling test and the situation of self-examination, self-correction and rectification and implementation of the quality management of the enterprise.
Remarks: the enterprise license renewal, "Medical Device Business License" content changes should be changed according to the content of the change to fill out the "Medical Device Business License Application Form for the old license for the new license", and according to the content of the change to submit the relevant change process requirements of the relevant materials and changes in the business description.
For details, please visit the official website of Freeda.