1, name and business scope of the enterprise, registered capital and proportion of shareholders' contribution, and identification of shareholders;
2, medical device product registration certificate, supplier business license, license and authorization;
3. Quality management documents, etc.
4. Certificates, identity certificates and resumes of two or more medical professionals or related professionals;
5, in line with the requirements of medical equipment business office space and warehouse proof;
6. Articles of Association, resolutions of shareholders' meeting, etc.
7. ID card and employment certificate of financial personnel;
8. Other relevant materials.
Application process of medical device knowledge license:
1. An operating enterprise shall apply to the local municipal drug supervision and administration department.
2. If the application materials are incomplete or do not meet the requirements of formal examination, the applicant shall be issued a Notice of Supplementary Materials on the spot or within five working days to inform the applicant of all the contents that need to be supplemented at one time. If it is not submitted within the time limit, it will be accepted as of the date of receipt of the application materials.
3. If the application materials are complete and meet the requirements of formal examination, or the applicant submits all the corrected application materials as required, it shall be accepted.
Medical device license processing: /ylqx/