Need to have with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have nationally recognized relevant professional qualifications or titles.
According to the "Medical Device Business License Management Measures":
Article 6 The application for the "Medical Device Business License" shall have the following conditions:
(a) with the scale of operation and the scope of operation of the quality management body or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed by the third party to provide technical support.
Expanded:
According to the "Medical Device Business License Management Measures":
Article 11 When applying for the "Medical Device Business License", the following information should be submitted:
(a) the "Medical Device Business License Application Form";
(b) industrial and commercial administrative departments Pre-approval of the enterprise name issued documents;
(C) the proposed enterprise quality management personnel identity card, academic or professional title certificate copies and biographical information;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address of the geographic location of the map, floor plan (indicating the area), proof of property rights (or lease agreement) a copy of the house. (F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(G) the proposed business scope.
Article XII of the applicant shall be to the proposed business location of the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to submit the "medical device business license" application for issuance.
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 accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following:
(a) the application does not fall within the purview of the department, it should be made immediately inadmissible Decision, issued a "Notice of Inadmissibility", and inform the applicant to the relevant departments;
(b) the application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot;
(c) the application materials are incomplete or do not comply with the statutory form, it should be on the spot or within five working days to the applicant to issue a "Notice of Supplementary Materials", a one-time notice of All the contents that need to be corrected. 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 a "Notice of Acceptance". Notice of acceptance" should be stamped with the acceptance of the special seal and indicate the date of acceptance.
Baidu Encyclopedia - Medical Device Business License Management Measures