Declaration materials:
Application for Class II medical device business enterprises should fill out in writing the "Class II Medical Device Business Record Form" (three copies) (this form can be obtained in the municipal government service center, the Pharmacovigilance Bureau of the Window), and submit the following declarations (in duplicate).
1) Class II medical device business filing form;
2) a copy of the business license;
3) legal representative or person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of, academic qualifications, titles;
4) enterprise organization and departmental setup description;
5) business address, warehouse address of the enterprise Geographic location map, floor plan (indicating the actual area of use), documents proving property rights or rental agreement (with documents proving property rights) copies;
6) business facilities and equipment directory;
7) business quality management system, work procedures and other documents directory;
8) proof of authorization of the operator;
9) other proofs Materials;
10) Self-assurance statement of the authenticity of the submitted materials: should include a list of the submitted materials, the operating enterprise to assume legal responsibility for the commitment.
Procedure:
1, the applicant company will declare the information and the second class of medical equipment business filing form to the municipal government service hall of the City Food and Drug Administration window, the window staff of the enterprise submitted by the local county and district Food and Drug Administration in the "for the registration of medical equipment filed on the form" after signing the comments on the information for review, the review conforms to the provisions of the issuance of the acceptance of the notice.
2, the window staff will be reviewed by the second class of medical devices business filing form sent back to the City Food and Drug Administration Medical Devices Supervision Section, the Medical Devices Supervision Section of the second class of medical devices business filing form for review and in the "for the medical device filing and registration form" on the signature of the opinion, and then sent to the Administrative Approval Section for the record.
3, the window staff with the "for medical devices for the record registration form," the audit opinion to print the "second class of medical equipment business record vouchers.
Application→Review→Approval→Production of filing vouchers