1, the second class of medical equipment business record application form;
2, business license and a copy of the organization code certificate;
3, legal representative, business management personnel, quality management personnel, personal identification, diploma qualifications or a copy of the certificate of title;
4, organizational Organizational structure and departmental settings described;
5, business scope, business mode described;
6, business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house);
7, management and management of ancillary facilities, machinery and equipment list;
8, management and management quality Management system, work procedures and other documents directory;
9, the operator's proof of authorization;
10, basic computer information system and functional description (encouraging the second class of medical devices operating companies to build a computer information system in line with the requirements of the quality of medical equipment business management, such as the absence of this, can be exempted from the elaboration);
11, other documents (such as the management of in vitro diagnostic reagents). If the management of in vitro diagnostic reagents, in vitro diagnostic reagents according to the application for the management of business management standards to provide medical testing personnel and cold chain facilities and equipment and other additional materials).
The conditions for medical device class II business record:
1, with the scale and scope of operation of the quality management organization or college degree or more than two quality management personnel. Quality management personnel should have a nationally recognized relevant academic qualifications or titles;
2, with the scale and scope of operation of relatively independent premises;
3, with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;
4, should be established and sound 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 appropriate technical training and after-sales service with its medical device products, or agreed by the third party to provide technical support.
The process of handling medical equipment Class II business filing:
1, the application does not belong to the department's purview according to law, shall immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative organs;
2, the application materials there are errors that can be corrected on the spot, the applicant shall be allowed to correct the error on the spot;
3, Application materials are incomplete or do not meet the formal review requirements, shall be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notification to the applicant needs to make corrections to all the contents of the late notification, from the date of receipt of the application materials shall be accepted;
4, the application materials are complete, meet the requirements of the form of review, or the applicant in accordance with the requirements to submit all the corrective application materials, be accepted.
5, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the application for the start-up of medical device manufacturers, should be issued with the special seal of acceptance of the department and indicate the date of the "acceptance of the notice" or "inadmissibility of the notice".
6, the review meets the requirements, to make a written decision to grant a license, and within 10 working days to the "medical device manufacturer license. After review does not meet the requirements, make a written decision not to issue a license, and explain the reasons.
The above is for medical equipment class II business record materials, today Zhishuo editorial sharing here, if you still have any questions about medical equipment class II business record materials, you are welcome to contact Shanghai Zhishuo Enterprise Management Group Co.