What are the medical devices that are allowed to be operated under the medical device license?

Hello, as long as your company complies with the relevant provisions of the legal application to the relevant medical devices corresponding to the medical device license, can be normal sales. If you need to increase the scope of the sales of products, you need to apply to the local food and drug supervision department to add or expand the project.

Engaged in the medical device business, should have the following conditions:

(a) with the scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized professional qualifications or titles;

(b) with the scope of operation and scale of operation of the business, storage space;

(C) with the scope of business and business scale appropriate storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;

(D) with the operation of medical devices appropriate quality management system;

(E) with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant institutions. Relevant organizations to provide technical support.

Enterprises engaged in the operation of Class III medical devices should also have a computerized information management system that meets the quality management requirements for the operation of medical devices, to ensure that the operation of the product can be traced. Encouraged to engage in the first class, the second class of medical devices business enterprises to establish a quality management of medical equipment business in line with the requirements of the computer information management system.

Engaged in the third class of medical devices business, the business enterprise shall be located in the district municipal food and drug supervision and management department to apply, and submit the following information:

(a) business license and a copy of the organization code certificate;

(b) legal representative, responsible person for the enterprise, responsible person in charge of quality of the identity of the person in charge of the identity card, a copy of the certificate of academic qualifications or professional titles;

(c) the legal representative, responsible person for the enterprise, responsible person in charge of the quality of the identity card, a copy of the certificate of education or title;< /p>

(c) organization and department setup description;

(d) business scope, business mode description;

(e) business premises, warehouse address location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) a copy of;

(f) business facilities, equipment directory;

() (G) business quality management system, work procedures and other documents directory;

(H) computer information management system basic information and functional description;

(IX) proof of authorization by the operator;

(X) other supporting materials.