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.

II. Requirements for licensing of three types of medical devices:

1. Site requirements: it must be of an office nature with a minimum usable area of 45 square meters;

2. Personnel requirements: 3 Relevant personnel (company leaders, quality supervisors and quality inspectors) shall be documented and certified;

3. Product requirements: there must be product information and certificates that meet the business scope;

4. Other relevant laws and regulations.

Three, the process of handling three types of medical device licenses:

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

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

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

4, granted three kinds of medical device license.

The above is an introduction to three types of medical device licensing agencies, and the procedures may be complicated. Please feel free to consult me if you don't understand anything.