Ten, reporting conditions
(1) the opening of the second, three types of medical equipment business license
① enterprises should have the scale and scope of business with the quality management organization or full-time quality management personnel, quality management personnel should have a nationally recognized professional qualifications or professional titles;
② enterprises should have the scale and scope of business with relatively independent business premises. business scope appropriate to the relatively independent premises;
③ enterprises should have with the scale and scope of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
④ enterprises should establish and improve product quality management system, including purchasing, purchase and acceptance, warehousing and storage, storage and review, quality tracking system and adverse event reporting system;
④ enterprises should establish and improve product quality management system, including purchasing, acceptance, warehousing and storage, review, quality tracking system and the adverse event reporting system.
⑤ Enterprises should have the ability to provide technical training and after-sales service appropriate to their medical device products, or agreed by a third party to provide technical support;
⑥ proposed to operate implantable (interventional) class of medical devices, should also be equipped with a college or above, or intermediate title or above, professional health professionals; proposed to operate a special fitting requirements of medical devices, should also be equipped with relevant professional health professionals; to operate special fitting requirements Medical devices, should also be equipped with relevant professional secondary education or junior title or above health technicians.
⑦ Enterprises should be in accordance with the "Zhejiang Province, medical equipment business enterprises on-site inspection score sheet" for self-examination, each part of the score rate of not less than 80%.
(2) to start the second, three types of medical equipment business license change
① apply for changes in the medical device business enterprises have not been drug supervision department to investigate;
② apply for changes in the medical device business enterprises have been drug supervision system to investigate, but has been closed; or has fulfilled the penalty;
③ business name, legal representative and other registration Matters change, should be applied for within 30 days after the approval of the business sector.
XI, material details
(1) the opening of the second, three types of medical equipment business license
① filled out "Medical Device Business License Application Form"
② business administration issued by the "pre-approval of the enterprise name notification" or "business license" (copy); to provide "pre-approval of the enterprise name" notice also need to provide "pre-registration of enterprise name application" (copy);
③ proposed business according to "Zhejiang Province, medical equipment business on-site inspection of the score sheet" of the self-inspection and the legal representative or person in charge of the opinion signed;
④ proposed business legal representative and responsible person's identity card (copy) and the decision on the appointment and removal of relevant personnel (copy);
⑤ proposed enterprise legal representative and responsible person's ID (copy);
⑤ proposed enterprise legal representative and responsible person's ID (copy) and relevant personnel appointment and removal decisions (copy);
⑤ Organizational chart of the proposed enterprise, functions and staff roster;
⑥ Academic qualifications or titles of the person in charge of the proposed enterprise, the person in charge of the quality management organization or quality management personnel and the main professional and technical personnel (copy), identity card (copy), personal resume and full-time and full-time post of the person's undertaking;