"Medical Device Business License" for conditions:
(1) with the scale and scope of operation of quality management institutions or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles.
(2) with the scale and scope of operation of relatively independent business premises.
(3) with the scale and scope of business appropriate storage conditions, including storage facilities, equipment (temperature and humidity meter, moisture-proof, waterproof matting, rodent-proof equipment) in line with the requirements of the characteristics of medical devices.
(4) should 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 adverse event reporting system;
(5) should have the ability to operate its medical device products with appropriate technical training and after-sales service, or agreed to provide technical support by a third party.
"Medical Device Business License" for the procedure (or process):
The municipal Food and Drug Administration for the applicant to apply for a "license" issued by the applicant, should be dealt with according to the following circumstances:
(1) the application does not belong to the department's terms of reference, should be made inadmissible decisions, issued "inadmissible Notice", and inform the applicant to apply to the relevant departments;
(2) application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(3) application materials are incomplete or do not comply with the statutory form, should be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notification of need to make up for the entire content. Late notification, since the date of receipt of the material is accepted;
(4) application matters within the department's purview, the application materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all the supplementary application materials, issued by the "Notice of Acceptance," the "Notice of Acceptance" shall be stamped with the acceptance of the special seal and indicate the date of acceptance.
(5) municipal Food and Drug Administration in the acceptance of 15 working days from the date of organization of personnel on-site inspection of enterprises. Inspection 3 days in advance to notify the enterprise inspection time. Inspection team based on "Guizhou Province medical device business inspection and acceptance standards" requirements, according to "Medical Device License Acceptance Scoring Schedule" on the inspection and acceptance of enterprises, fill out the "on-site inspection and acceptance records" concluded that the municipal (state, local) Food and Drug Administration, the municipal (state, local) Bureau to fill out the "Medical Device License Review". "Medical Device License Review Form" (in duplicate) reported to the provincial bureau.
(6) Provincial Food and Drug Administration Medical Devices Division of the city (state, place) Food and Drug Administration reported to the proposed business information and review the conclusions of the review, and whether to issue "medical device business license" opinions, reported to the Bureau of Leadership for approval, review and approval of the work within 15 working days. Meet the requirements, in Guizhou Province Food and Drug Administration website publicity, publicity period of 7 days, if there is no complaint, report and other issues, the approval of the issuance of "medical device business enterprise license", and within 10 days to the applicant to issue the "medical device business enterprise license". Does not meet the requirements, the applicant shall be notified in writing and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or the right to file an administrative lawsuit.