Secondary medical equipment sales license to handle the information

___In our country, there are some special industries, is the need for specific credentials can be opened, similar to the medical equipment industry

industry, related to the human body problems, naturally, it is also very strict, then, for the Class II medical device license, what materials are needed

and through which process? The following Mazars enterprise service to answer for you, I hope to help you.

First, for the second class of medical equipment license required materials

1, "medical equipment business license application form", "medical equipment business license.

2, the administrative department for industry and commerce issued by the "pre-approval of enterprise name notice" or "business license.

3, application report.

4, business premises, warehouse premises documents, including property certificates or lease agreements and the lessor's copy of the property certificate

print.

5, business premises, warehouse layout plan.

6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality of the person's identity card, proof of education or title certificate copies

and personal resume.

7, the list of technical staff and academic qualifications, copies of title certificates.

8, business quality management standardized document catalog.

9, the enterprise has installed the product purchase, sale, inventory information management system, print information management system home page.

10, storage facilities and equipment catalog.

11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the application materials catalog

and the enterprise to make the materials, if false, to assume legal responsibility for the commitment;

12, where the application for the enterprise to declare the materials, the processing staff is not the legal representative or person in charge of himself, the enterprise should submit the "authorization

power of attorney".

13, apply for a "medical device business license" confirmation.

Second, for two types of medical equipment license process

1, first of all, to the Trade and Industry Bureau for business license, registered as an enterprise, can be a legal person enterprise, unincorporated business, sole proprietorship

enterprises, partnerships, etc., individual businessmen can not apply for the record vouchers.

2, and then to the Quality Supervision Bureau for the organization code certificate.

3, and finally to the State Food and Drug Administration website with the organization code to register an account, online reporting.

4, online filing of "medical device filing application form" need to submit electronic materials, which add * for the necessary items.

Third, for two types of medical equipment license conditions

1, with the scale and scope of operation of the quality management organization 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 the characteristics of medical equipment products in line with the requirements of the storage facilities, equipment;

4, should be established. 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 its business with the medical device products appropriate technical training and after-sales service capabilities, or agreed by

third party to provide technical support.