What are the materials required for the renewal of the Medical Device Operator's License?

Application materials including paper and electronic version, paper materials need to be stamped with the seal of the enterprise

First look at the products you are operating under the control of which Drug Administration, the provincial bureau or municipal bureau, call and ask, mainly depending on the type of products you operate. Then prepare the above materials. After accepting the material, the site acceptance within a month. The above materials have to prepare a two or three times, it can let you pass. Note that in 2010, whether it is a new start-up or license renewal enterprises have to have 1-2 internal auditors. This to the local Medical Devices Association to test. 1-2 months under the license. Good to pass.

Business enterprises to submit the following information:

(1) "Medical Device Business Enterprise License Renewal Application Form";

(2) "Medical Device Business Enterprise License" and a copy of the original and copies of the industrial and commercial business license (the original is returned after checking the original, the original copy of the original to retrieve the license returned);

(3) the quality of the quality management person's identity card, education, Title, original and copy of the training certificate and resume (original certified and returned);

(4) enterprise organization chart, institutional functions and staff roster;

(5) business address and warehouse address of the geographical location map, business premises and warehouse layout plan (indicating the area), proof of ownership of the house, lease agreement (contract) and the lessor of the property rights of the original and copy (original certified) and photocopies (the original is returned after checking);

(6) quality management system document catalog;

(7) storage facilities and equipment directory;

(8) enterprise business product catalogs, copies of registration certificates and authorization of agency;

(9) the applicant shall be responsible for the authenticity of the declaration of all the contents of the information, the declaration of information, if any, shall bear legal responsibility for the declaration of the information commitment to bear legal responsibility, and signed by the legal representative.