Three types of medical devices to know the materials required for the registration of equipment license
1, business name and scope of business, registered capital and shareholders' contribution ratio, shareholders and other proof of identity;
2, medical device product registration certificates, supplier business license, permits and authorization;
3, quality management documents and so on.
4, two or more medical or related professional certificates, identification and resume;
5, meet the requirements of the medical device business office space and warehouse certificate;
6, articles of incorporation, shareholders' meeting resolution;
7, financial personnel identity cards and certificates of competency;
8, and other relevant materials.
Medical equipment know equipment license application process:
1. Business enterprises should be located in the area of municipal drug supervision and management departments responsible for the 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 shall be 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.
Medical device license for:/ylqx/