(a) "Medical Device Business License Application Form";
(b) business name pre-approval issued by the administrative department for industry and commerce documents proving;
(c) proposed business quality management personnel's identity card, academic or professional title certificate copies and Personal resume;
(d) the proposed enterprise organization and functions;
(e) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), proof of ownership of the house (or lease agreement) copy;
(f) the proposed enterprise product quality management system documents and storage facilities, equipment directory;
(vii) Proposed business scope of the enterprise.
The applicant shall be to the proposed business location of provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or to accept the entrusted municipal (food) drug supervision and management agencies to make "medical device business license" application for issuance.
Legal basis
"Measures for the Administration of Medical Device Business License" Article 11 When applying for "Medical Device Business License", the following information shall be submitted: (a) "Medical Device Business License Application Form"; (b) business administration department issued by the enterprise name pre-approval of the documents proving the name of the enterprise; (c) the proposed enterprise quality management personnel's identity card, (C) the proposed enterprise quality management personnel ID card, academic or professional title certificate copies and personal resume; (D) the proposed enterprise organization and functions; (E) the proposed enterprise registered address, warehouse address location map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copies; (F) the proposed enterprise product quality management system documents and storage facilities, equipment directory; (G) the proposed enterprise business scope.
"Medical Device License Management Measures" Article 12 The applicant shall apply to the proposed business location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments, or to accept the entrusted municipal (food) drug supervision and management agencies to submit a "medical device license" application for issuance of licenses.
For the applicant's "medical device business license" licensing application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or to accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following: (a) the application does not belong to the terms of reference of the department, should be made instantly inadmissible decision to issue "not admissible notice" and issue "notification of inadmissibility" and "notification of inadmissibility". Notice of Inadmissibility", and inform the applicant to the relevant departments; (b) the application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(c) the application materials are incomplete or do not meet the statutory form, it should be on the spot or within five working days to the applicant to issue a "Notice of Rectification", a one-time notification of the need to make corrections to the full content. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application matters within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued by the "Notice of Acceptance". Notice of acceptance" should be stamped with the acceptance of the special seal and indicate the date of acceptance.