Three types of medical devices have no filing information form ah

Application for three types of medical equipment business filing vouchers required application materials:

1. three types of medical equipment business filing form;

2. Organizational business license and a copy of the code certificate;

3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the Ming, a copy of the certificate of education or professional title;

4. Organization and departmental Setting description;

5. Scope of business, business mode description;

6. Business premises, warehouses, address geographic location map, floor plan, proof of property rights or housing rental issued by the lease certificate copy;

7. Business facilities, equipment directory;

8. Business quality management system, work procedures and other documents directory;

9. The operator's authorization certificate

For medical equipment three types of business license to complete the following process:

1, the scope of business should be "sales of medical equipment"

2, online application for submission of medical equipment materials

3, drug supervision window to submit the three types of materials (with the originals), waiting for the Notify the verification

4, get a medical device license (if there is a second class, submit the materials, the same day under the record sheet)

Processing period:

1, the validity of the three types of: 5 years

2, two types of the record sheet: there is no validity period

3, the processing time: five working days after the acceptance of the materials

The above is the process for the Medical device license required information process and the next certificate time, while you also need to provide the following materials:

1, business name and scope of business, registered capital and the proportion of shareholders' contributions, shareholders and other identity Ming;

2, medical device product registration certificate, supplier business license, permits and authorization;

3, quality management documents and so on;

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

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

6, articles of incorporation, shareholders' meeting resolutions, etc.;

7, the identity of the financial staff and the certificate of induction.