About the medical device license in the quality manager's problem

Problems of application: you need to know the application is a few categories of medical devices, to do several kinds of products and other issues;

Problems (medical device accidents), then the quality manager is not related, and quality management personnel are not allowed to work part-time.

To apply for a medical device license for a new company, you need to prepare the following materials:

Application Form for Medical Device License;

Proof of pre-approval of the business name issued by the administrative department for industry and commerce;

Copy of ID card, academic qualifications, professional title and resume of the quality manager of the proposed enterprise;

The quality manager of the proposed enterprise is not allowed to take part in the work of the company.

The organization and functions of the proposed enterprise;

The registered address of the proposed enterprise, warehouse address of the geographic location map, floor plan (indicating the area), a copy of the certificate of property rights of the house (or lease agreement);

The proposed enterprise product quality management system documents and storage facilities, equipment catalog;

The proposed enterprise business scope.

Have a quality management organization or full-time quality administrator appropriate to the scale and scope of business. Quality management personnel should have a nationally recognized relevant professional or professional title;

with business norms and business scope of the relatively independent premises;

with business norms and business scope of the storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of the medical device products;

should be established and improved product quality

Should establish a sound product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking and quality of bad time reporting system;

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

The regional requirements are also a little different; the details of the requirements have a lot of.