Execution authority: district/county Food and Drug Administration

Application procedure:
Execution procedure:
(I) Procedure for application for establishment
1. The applicant for establishment of a Type 2 or 3 Medical Appliances Trade Enterprise shall submit an application and following documents to the local district/county Food and Drug Administration:
(1) "Commitment in Advice of Application for Establishment of Medical Appliances Trade Enterprise";
(2) "Notification on Approval of Preselected Enterprise Name" checked and issued by the administrative authority for industry and commerce;
(3) Copy of ID card of the legal representative;
(4) Other certification documents required.
2. Within 5 working days since reception of the commitment form and the relevant documents, the district/county Food and Drug Administration shall issue the "Notification on Approval of Establishment of Medical Appliances Trade Enterprise", if the application is approved. The applicant shall apply for the business license to administrative authority for industry and commerce subject to the "Notification on Approval of Establishment of Medical Appliances Trade Enterprise".

Should the applicant apply for the business covering all types of medical appliance, it shall submit the application to municipal Food and Drug Administration.
(II) Procedure of approval
1. After the enterprise accomplishes the project preparation as required by "Interim Regulations of Shanghai on Establishment and Approval of Medical Appliances Trade Enterprises", it shall apply for the "License of Medical Appliances Trade Enterprise" and submit following documents to local Food and Drug Administration:

(1) "Application Form for License of Medical Appliances Trade Enterprise";
(2) Copy of business license, with official seal;
(3) Copy of qualification certificate and training certificate of major management staff;
(4) Documents indicating the right of using the business place or storage place: (copy of house ownership certificate or the house ownership certificate of the lessor and the lease contract);
(5) Self-evaluation table for the qualification of the business;
(6) Catalogue of quality management system;
(7) If the business is a branch, it shall submit the commitment letter of responsibility issued by the superior company;
(8) Other certification documents required.
2. Within 15 working days since the reception of the application materials, the district/county Food and Drug Administration shall review the materials and conduct a field investigation and thus make the decision, issuing "License of Medical Appliances Trade Enterprise" to the qualified applicant or notifying the unqualified of the reasons for rejection in written form.

The application made by the applicant who applies for a business scope covering all types of medical appliance shall be reviewed and approved jointly by the municipal Food and Drug Administration and the local Food and Drug Administration in charge of the business place of the applicant. The routine administration shall be executed by the local Food and Drug Administration.
(III) Application for change
1. If the business plans to change the content in the "License of Medical Appliances Trade Enterprise", it shall submit an application and following documents to the local Food and Drug Administration:
(1) "Application Form for Change in the Medical Appliances Trade Enterprise";
(2) Original and duplicate copy of "License of Medical Appliances Trade Enterprise";
(3) Copy of business license;
(4) Different documents in accordance with the items to be changed:
Change of legal representative or principal of the business: approval of superintendent authority and solution of board of directors, copy of ID card of new legal representative or the new principal and the training certificate.
Change of enterprise name: copy of "Notification on Approval of Preselected Enterprise Name" verified by the authority for industry and commerce.
Change of business location: lease contract and/or house ownership certificate.
Change of business scope: copy of qualification certificate and training certificate of major management staff, self-evaluation table for the qualification of the business and catalogue of quality management system.
(5) Other certification documents required.
2. The district/county Food and Drug Administration shall make the decision within 5 days since accepting the application in case for change of legal representative, principal and enterprise name or 10 days working days since accepting the application in case for change of business location and business scope.

The application made by the applicant who applies for a business scope covering all types of medical appliance shall be reviewed and approved jointly by the municipal Food and Drug Administration and the local Food and Drug Administration in charge of the business place of the applicant. The routine administration shall be executed by the local Food and Drug Administration.
Standard and basis of charge: 300 yuan for each "License of Medical Appliances Trade Enterprise"

Submitted to:
Execution address:
audituser：
Basis of execution: (I) "Regulations on Supervision and Management of Medical Appliances", No. 276 Decree of State Council;

(II) "Measures on Administration of Medical Appliances Trade Enterprises", No. 19 Decree of State Food and Drug Administration;

(III) Category of Chinese Medical Appliances;

(IV) "Some Regulations on the Administration of Disposable Bacteria-free Medical Appliances in Shanghai", No. 5 Decree of Shanghai Municipal Government;

(V) "Measures on the Administration of Disposable Bacteria-free Medical Appliances", No. 24 Decree of State Food and Drug Administration;

(VI) "Detailed Rules on Implementation of Qualification Approval on Disposable Bacteria-free Medical Appliance Trade Enterprises (Interim Version)", No. GUOYAOJIANSHI (2001) 444;

(VII) "Interim Regulations of Shanghai on Establishment and Approval of Medical Appliances Trade Enterprises", No. HUYAOJIAN (2002) 650;

(VIII) "Some Regulations of Shanghai on the Application for Changes of License of Medical Appliances Trade Enterprise", No. HUYAOJIAN (2002) 883;

(IX) "Reply of Agreement on Charging for the Review of License of Medical Appliances Producing and Trade Enterprise", No. HUCAIZONG (2000) 46 and No. HUJIAHANG (2000) 158, issued by Shanghai Finance Bureau and Shanghai Price Bureau.

Contact phone:
Website:
Duration of service: 9:00-11:00 and 13:00-16:00, every Tuesday and Thursday

Time limit:
Applicant's qualification: Scope of application:

The requirements of establishment for the applicant, as the Type 2 or 3 medical appliances business, for establishment, approval and change (of business) are as following:

(I) With proper business place and environment;

(II) With relevant quality inspection staff;

(III) Able to provide after services, like training and maintenance, for the products;

(IV) With quality management system for the medical appliances;

(V) Collecting and keeping the national standards and industrial standards on medical appliances.