1. There are two with the business scale and scope of business appropriate quality management institutions or quality management personnel with college education. Quality management personnel should have nationally recognized relevant professional qualifications or titles;
2. With relatively independent business premises appropriate to the scale and scope of business;
3. With storage conditions appropriate to the scale and scope of business, including storage facilities and equipment in line with the characteristics of the medical device;
4. Establishment and improvement of product quality management system. Including procurement, purchase and acceptance, warehousing, warehousing audit, quality tracking system and adverse event reporting system;
5. With its operation of medical equipment products corresponding to the technical training and after-sales service capabilities, or agree to a third party to provide technical support.
Three types of medical devices know the materials required for the registration of equipment licenses1, business name and scope of business, registered capital and the proportion of shareholders, shareholders and other proof of identity;
2, medical device product registration certificates, supplier business license, permits and authorization;
3, quality management documents;
4, two or more medical professionals or related professional certificates, proof of identity and resume. Professional certificates, identification and resume;
5, office space and warehouse certificate in line with the requirements of the medical device business;
6, articles of association, shareholders' resolutions, etc.;
7, the financial personnel ID card and induction certificate;
8, other relevant materials.
Medical equipment know how to apply for a license process:1. Business enterprises should be located in the municipal level responsible for drug supervision and management of the department to submit an application.
2. Application materials are incomplete or do not meet the formal review requirements, should 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 a one-time notification, notification of late, since the date of receipt of the application materials is accepted.
3. Application materials are complete, meet the formal review requirements, or the applicant in accordance with the requirements to submit all corrective application materials, be accepted.
Three types of medical devices license process:/ylqx/