What conditions should the grouping matching method meet?

I. Project name 1. The second and third types of medical device business license. Changes in the license of the second and third types of medical device business enterprises. Acceptance organization: Medical Devices Division of Zhejiang US Food and Drug Administration 3. Administrative licensing items of project types. Location contact Chen Yuhong 6. Clients: 7 second-class and third-class medical device enterprises. (1) comes next. Within 30 working days of Class III medical device business license (2) Change of Class II and Class III medical device business license ① Change requiring on-site inspection: 20 working days ② Change not requiring on-site inspection: 15 working days. No charge. The establishment is based on the Regulations on the Supervision and Administration of Medical Devices (Order No.276 of the State Council) X. Application conditions (1). Three types of medical device business enterprise license ① An enterprise shall have a quality management organization or full-time quality management personnel suitable for the scale and scope of business, and the quality management personnel shall 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 audit, 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%. (II) Changes in the licenses of Class II and Class III medical device trading enterprises ① The medical device trading enterprises applying for changes have 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) II and III types of medical device business license ① Complete Application Form for Medical Device Business License 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 "Zhejiang medical device enterprises on-site inspection score table" and the opinions signed by the legal representative or person in charge, conduct self-examination on the enterprises to be applied for; (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) A list of the organization, functions and personnel of the enterprise to be established; ⑥ Certificate of education or professional title (photocopy) and ID card (photocopy) 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, resume and full-time post commitment letter; I don't know which province you want, but I'm from Zhejiang Province. For the rest, see Freda official website.