X. reporting conditions
(1) It is allowed to start the second and third types of medical device enterprises.
(1) enterprises should have quality management institutions or full-time quality management personnel suitable for the scale and scope of operation, and quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) The enterprise should have a relatively independent business place suitable for its business scale and scope;
(3) An enterprise shall have storage conditions suitable for its business scale and scope, including storage facilities and equipment that meet the requirements of medical device products;
(four) the enterprise shall establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound review, quality tracking system and adverse event reporting system;
⑤ The enterprise shall have the technical training and after-sales service ability suitable for the medical device products it operates, or agree to provide technical support by a third party;
⑥ Professional health technicians with college degree or above or intermediate title should also be provided for those who intend to operate implantable (interventional) medical devices; Those who intend to operate medical devices with special assembly requirements shall also be equipped with health technicians with technical secondary school education or junior professional titles.
All landowners enterprises in accordance with the "Zhejiang medical device enterprises on-site inspection scale" for self-examination, the scoring rate of each part is not less than 80%.
(2) the second and third types of medical device enterprises to start the license change.
① The medical device business enterprise applying for change has not been investigated by the drug supervision department;
(2) The medical device business enterprise applying for change has been investigated by the drug supervision system, but the case has been closed; Or has fulfilled the punishment;
(3) An application shall be filed within 30 days after the approval of the industrial and commercial department for the change of enterprise name, legal representative and other registered items.
XI。 Material details
(1) It is allowed to start the second and third types of medical device enterprises.
(1) The Application Form for Medical Device Business License has been filled in.
② Notice of pre-approval of enterprise name or business license (copy) issued by the administrative department for industry and commerce; Where the Notice of Pre-approval of Enterprise Name is provided, an Application for Pre-registration of Enterprise Name (photocopy) is also required;
(3) According to the Scoring Form for On-site Inspection of Medical Device Enterprises in Zhejiang Province and the opinions signed by the legal representative or person in charge, conduct self-examination on the enterprises to be operated;
(4) The ID cards (photocopies) of the legal representative and person-in-charge of the proposed enterprise and relevant personnel appointment and removal decision documents (photocopies);
⑤ Organization chart, functions and personnel list of the proposed enterprise;
⑥ Certificate of education or professional title (photocopy) and ID card (photocopy), resume and full-time post commitment letter of the person in charge of the proposed enterprise, person in charge of quality management organization or quality management personnel and major professional and technical personnel;