The Class II medical device license is one of the necessary documents for business, the specific conditions are as follows:
1, with its said scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have nationally recognized relevant professional qualifications or technical titles.
2, with its said scale and scope of operations to match the relatively independent business premises.
3, should have the necessary conditions for storage to match the scale and scope of business, including storage facilities and equipment to meet the need to meet the requirements of the characteristics of medical devices.
4, the establishment and improvement of the quality of goods certification system, including the acquisition, take goods inspection and acceptance, warehousing and logistics, storage approval, quality tracking system and other adverse event reporting management system.
5, should have the professional and technical training and product after-sales service that matches the medical devices it says it manipulates, or allow support from a third-party platform.
Materials required for medical device license
1, "Medical Device Business License Application Form".
2, "notice of pre-approval of enterprise name" or "industrial and commercial business license.
3, business premises, warehouse premises supporting documents, including property certificates or lease agreements and a copy of the lessor's property certificates.
4, business premises, warehouse layout plan.
5, the proposed method to determine the person in charge, the person in charge of the enterprise, the quality of the person in charge of the identity card, a copy of the certificate of academic qualifications or title certificate and personal resume.
6, technician search list and copies of academic and professional title certificates.
7, operating quality management specification document catalog.
8, the enterprise has installed the product purchase, sale and inventory of information management system, print information management system home page.
9, storage facilities and equipment catalog.
10, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the catalog of application materials and materials made by the enterprise if the false commitment to bear legal responsibility.
The above content refers to Baidu Encyclopedia - "Medical Device License"