The following enterprises will no longer be renewed, the original "license" to be canceled:
1, only the operation of Class I medical device products and the State Food and Drug Administration does not need to apply for a "license" of the second class of medical devices products
2, the termination of the operation of medical devices;
3, not in the original "license" before the expiration of the application for renewal.
Two, renewal approval process
(A) business application
Enterprises should be in the "license" six months before the expiration of the validity of the license, but not less than 30 days before the application for renewal, and submit the following materials.
1, the enterprise renewal application materials cover and directory (including serial number, material name, page number);
2, "xx Province, medical device business application for renewal of the license review form" in duplicate (see Appendix 1);
3, "license" and a copy of the original copy of the copy;
4, enterprise "business license" copy;
5, enterprise quality management personnel ID card, a copy of proof of education or title and resume, certified by the contract authentication authority of the labor contract;
6, implantable medical devices and sales of home therapeutic medical devices to individuals in the enterprise's medical staff ID card, education and title copy of proof and certified by the contract authentication authority of the labor contract;
6, implantable medical devices and sales of home therapeutic medical devices to individuals in the enterprise medical staff ID card, education and title copy and certified by the contract authentication authority of the labor contract. Contract authentication authorities certified labor contract;
7, the business of medical equipment for personal testing and dispensing enterprises of professional and technical personnel certificates, copies of identity cards and certified by the contract authentication authorities certified labor contract, testing and dispensing equipment and instrumentation list (indicating the name, specifications and models, manufacturers, instrumentation, number, number);
8, the enterprise's registered business address and the address of the warehouse Lease agreement, a copy of proof of property rights, floor plans (indicating the area) and geographic location map;
9, the enterprise quality management system of medical devices catalog;
10, the relevant personnel of the enterprise by the drug regulatory authorities issued by the Department of training and qualification of the "Certificate of Competent Training" copy (submitted for verification of the original);
11, electronic version of the material USB flash drive (see Annex 2 "electronic version of the material declaration instructions");
12, "administrative licensing (administrative confirmation) application materials to ensure the authenticity of the statement" (see Annex 3)
Renewal of the license process