Shanghai three kinds of medical equipment license how to deal with? What materials are required!

Shanghai how to apply for two or three types of medical equipment business enterprise license? First, the application conditions: Application for "medical device business enterprise license" should also have the following conditions: (a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles; (B) with the scale and scope of operation of relatively independent business premises; (C) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical equipment products; (D) should establish and improve the product quality management system, including purchasing, purchase and acceptance, storage and storage, out of stock (D) 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, etc.; (E) should have the ability to operate with its medical device products appropriate technical training and after-sales service, or agreed to provide technical support by a third party. Second, the procedure: 1, the opening of the second, three types of medical equipment business enterprises, should apply to the operating location of the Food and Drug Administration Branch and submit the following information: (1) "Shanghai Medical Devices Business License Application Form"; (2) "Medical Devices Business License Application Materials Registration Form"; (3) industrial and commercial administration issued by the business name pre-approval of the documents or "Business License Copies (check the original); (4) the proposed enterprise quality management responsible person's identity card, education or title certificate copies and biographical information; (5) the proposed enterprise quality management personnel's identity card, education or title certificates; (6) the proposed enterprise organization and functions or full-time quality management personnel functions; (7) the proposed enterprise registration, warehouse location map, floor plan (indicating the area), proof of ownership of housing Area), proof of ownership or lease agreement (with proof of ownership of leased premises, the same below) copies; (8) proposed enterprise product quality management system and storage facilities, equipment catalog. Acceptance of the branch should be in accordance with the "Medical Device License Management Measures" Article 12, paragraph 2 of the provisions of the processing decision. District (county) Food and Drug Administration Branch accepts the application information, shall be accepted within 30 working days from the date of data review and on-site review, and make a decision on whether to issue a "medical device business license". Considered to meet the requirements, should be made to grant the issuance of "medical device business license" decision, and within 10 working days from the date of decision to the applicant to issue "medical device business license". That does not meet the requirements, shall notify the applicant in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law. 2, apply for the business scope of "all types of medical devices" enterprises, by the Municipal Food and Drug Administration in conjunction with the county where the enterprise is operating food and drug regulatory branch for approval, day-to-day supervision by the branch is responsible for. 3, enterprise separation, merger or migration across the original jurisdiction, should be in accordance with the provisions of the re-application of "medical device business license.