Class III medical permit

Materials required for license registration of Class I and III medical devices:

1, enterprise name and business scope, registered capital and shareholder investment ratio, shareholder identification;

2, medical device product registration certificate, supplier business license, license and power of attorney;

3, quality management documents;

4, 2 or more medical or related professional certificates, identity certificates and resumes;

5, meet the requirements of medical equipment business office space and warehouse certificate;

6. Articles of association, resolutions of shareholders' meeting, etc.;

7, financial personnel ID card and work permit;

8. Other relevant materials。

Second, the requirements for the license of three types of medical devices:

1, site requirements: must be office nature, the use of the area to reach at least 45 square meters;

2, personnel requirements: need to have 3 relevant personnel (company responsible person, quality responsible person, quality inspection personnel) record and hold a certificate;

3, product requirements: must have product information in line with the scope of business, and issue a certificate;

4. Other relevant laws and regulations。

Third, the process of handling the license of three types of medical devices:

1. The applicant submits the application materials to the relevant departments;

2, the relevant departments accept the application of the applicant;

3, to the actual site for investigation and product audit;

4. Grant licenses for three types of medical devices。

The above is the relevant introduction of the three types of medical device business license agent, the procedure may be more cumbersome, it is recommended to hand over to a professional agency agent。