A, Class III Medical Device License Registration Required Materials:
1, business name and scope of business, registered capital and shareholders' contribution ratio, shareholders and other identification;
2, medical device product registration certificate, supplier business license, license and Authorization letter;
3, quality management documents, etc.
4, two or more medical or related professional certificates, identification and resume;
5, office space and warehouse certificates in line with the requirements of the medical device business;
6, articles of association, shareholders' meeting resolutions, etc.
7, financial personnel identity cards and certificates of competence;
8, financial personnel identity cards and certificates of competence;< /p>
8, other related materials.
Two, for the three types of medical equipment license requirements:
1, site requirements: must be office nature, the use of the area should be a minimum of 45 square meters;
2, personnel requirements: the need to have three relevant personnel (the company responsible for the person in charge of the quality of the person in charge of the quality of the quality of the inspector) for the record and hold the certificate
3, product requirements: must have the product information in line with the scope of business and issue certificates;
4, other relevant laws and regulations.
Three, for the three types of medical equipment license process:
1, the applicant to submit the application information to the relevant departments;
2, the relevant departments to accept the applicant's application;
3, to the actual site for investigation and review of the product;
4, the granting of the three types of medical equipment license. medical device license.
The above is the introduction of the three types of medical device license, the procedure may be more cumbersome. There is no understanding can always consult me.