Medical equipment business license application

Medical equipment license which is certainly related to medical equipment, medical equipment which is directly related to our health, so it must be strict requirements, the company must have medical equipment business license. So how to apply for a medical device license? What are the conditions for the application of medical device license and the application process?

First, the application for a medical device license should have the following conditions:

1. With the scale and scope of operation of the quality management institutions or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;

2. With the scale and scope of operation of relatively independent business premises;

3. With the scale and scope of operation of appropriate storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;

4. Should establish and improve the product quality management system Including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;

5. Should have the appropriate technical training and after-sales service capabilities of its medical device products, or agreed by the third party to provide technical support.

Medical Device License

Second, the medical device license application process:

open the second, three types of medical devices operating companies, should be operating in the local food and drug regulatory branch to apply and submit the following information:

1. "Medical Device License Application";

2. "Medical Device License Application Material Registration Form"; 3. p> 3. Industrial and commercial administration issued by the company name pre-approved documents or "business license" copy (check the original);

4. Proposed company's quality management responsible person's identity card, certificate of education or title and a copy of the resume;

5. Proposed company's quality management personnel's identity card, certificate of education or title;

6. Proposed company's organizational structure and Functions or full-time quality management personnel functions;

7. Proposed company registration, warehouse location map, floor plan (indicating the area), proof of ownership or lease agreement (with proof of ownership of leased premises, the same below) copy;

8. Proposed company product quality management system, documentation and storage facilities, equipment directory.

Medical devices are directly related to our health, so the state has strict requirements, the above is the medical device license application conditions and application process, we mainly consider the application conditions, if the conditions are met, it is entirely possible to find on behalf of the registration company to help apply for a medical device license, so the success rate will be higher!