According to the "Regulations for the Administration of Medical Devices", the medical equipment business license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing laws and regulations for the continuation of procedures. If the enterprise in the medical equipment business license is not renewed before the expiration of the validity of the license, resulting in the expiration of the license, you need to re-apply for the medical equipment business license.
While in the process of applying for a medical device license, the production site, environmental conditions, production equipment and professional and technical personnel appropriate to the production of medical devices is a necessary condition for the qualification, which can not normally be replaced by other materials.
The materials to be submitted for the medical device license are as follows:
1. Provincial bureau website to fill in the second class of medical devices business record form, ?
2. A copy of the business license and medical device business license (if any);
3. A copy of the enterprise legal representative or person in charge, the person in charge of quality of the identity of the person in charge, academic qualifications, titles;
4. Description of the enterprise's organizational structure and departmental setup;
5. The scope of business and the mode of operation description (to create a form, indicating the product code Product name, product name, registration number, sales channels)
6. Business premises, warehouse address of the geographic location map, office space, internal floor plan, warehouse internal floor plan (indicating the length, width and floor height), documents proving ownership of the house and a copy of the lease agreement (with documents proving ownership of the house);
7. Enterprise business facilities and equipment catalog;
8. . business quality management system, work procedures and other documents directory;
9. Proof of authorization of the operator;
10. The authenticity of the materials submitted by the enterprise to ensure the statement
11. Other supporting materials (business scope including in vitro diagnostic reagents need to provide the following materials: in vitro diagnostic reagents test personnel ID card, test related professional university degree or certificate of competent Inspector title certificate; refrigerated truck purchase invoice and license; cold storage invoices; automatic temperature recording equipment invoices; standby generator invoices; quality management software invoices)
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