How to replace the medical device business license in Henan Province when it expires?

Call the Food and Drug Administration of the jurisdiction to inquire, and the process is similar to the previous application mode. 1. Scope of renewal: Enterprises that hold Class II and Class III medical devices licenses need to continue their business after the license expires. The following enterprises will not renew their certificates, and the original License will be cancelled:

1, which only deals in Class I medical device products and Class II medical device products that do not need to apply for a License as stipulated by the US Food and Drug Administration;

2. Termination of medical device business;

3. The original "Permit" did not apply for replacement before the expiration.

Second, the renewal approval procedures

(1) When applying, an enterprise shall apply for renewal of the license 6 months before the expiration of the validity period of the license, but not less than 30 days before, and submit the following materials.

1, cover and catalogue of application materials for enterprise renewal (including serial number, material name and page number);

2. Approval form for replacement of medical device enterprises in 2.xx Province in duplicate (see Annex1);

3. The original and copy of the License;

4. A copy of the business license of the enterprise;

5, enterprise quality manager's ID card, diploma or title certificate copy and resume, the labor contract certified by the contract verification organ;

6. Implantable medical devices and home therapeutic medical devices sold to individuals, copies of enterprise medical technicians' ID cards, academic qualifications and professional titles, and labor contracts verified by contract verification organs;

7. A copy of the professional and technical personnel certificate and ID card of the enterprise engaged in providing medical devices for individuals, and a list of equipment and instruments (indicating the name, specification, manufacturer, instrument number and quantity) for the labor contract verified by the contract verification organ;

8. The lease agreement of the registered business address and warehouse address of the enterprise, a copy of the house property certificate, the floor plan (indicating the area) and the geographical location map;

9, enterprise medical device quality management system directory;

10, a copy of the Training Certificate issued by the relevant personnel of the enterprise after being trained by the drug supervision department (submit the original for verification);

1 1, USB flash drive of electronic materials (see Annex 2 "Description of Electronic Materials Declaration");

12, statement of authenticity assurance of application materials for administrative license (administrative confirmation).