1. Application Form for Medical Device Business License.
2. The original and photocopy of the enterprise name pre-approval notice or business license issued by the administrative department for industry and commerce; (Submit the original).
3 quality management personnel's ID card, education or professional title certificate and the original and photocopy of their resumes; (Submit the original).
4. Organization and functions; .
5. The registered address (referring to the registered business address of the enterprise) and the geographical location map and floor plan (indicating the area) of the warehouse address, as well as a copy of the certificate of property right and use right of the house; .
6. Product quality management system file directory; .
7 enterprises engaged in in in vitro diagnostic reagents shall submit the following application materials at the same time:
(1) A copy of the academic qualifications and resumes of the legal representative and person-in-charge of the proposed enterprise; (Submit the original).
The original and photocopy of the qualification certificate and letter of appointment of licensed pharmacist; (Submit the original).
(3) A copy of the certificate and letter of appointment of the inspector in charge, as well as a copy of the certificate of bachelor degree or above in inspection related majors and the certificate of more than 3 years of inspection related work; (Submit the original).
(4) Scope of business products; .
(5) The business premises, equipment, storage facilities and surrounding sanitary environment to be established; .
⑥ Quality management documents and storage facilities and equipment catalogue of the proposed enterprise; .
8. Self-assurance statement on the authenticity of the declaration 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.