1 Application Form of Overseas Medical Devices.
2 Qualification Certificatte of Manufacturer of Medical Devices.
3 Business License copy of appliers and Appointment of Registration issued by Manufacturers.
4 Original registration certificate
5 Market Approval Certificate of Medical Devices approved or authorized by the Medical Devices Competent Administrative Department of Overseas Government.
6 Applicable Product standard and compiling declaration(two copyies)
7 Instructions for use (User manual) of Medical Devices.
8 Registration test report of procuts issued by the Medical Devices test organization(Adapting for the Class II and III Medical Devices)
9 Quality tracking report of products
10 Product Quality Guaranty issued by the Manufacturers.
11 Authorization of Agent,Commitment of Agent and Business license of Agent.
12 Authorization of After-Sale Services organization,Commitment of After-Sale service organization and Business license of After-sale service organization.
13 If it belong to the Aricle 34 of <Registration management regulation of Medical Devices>,please provide the relevant statement and certificate documents.
14 Declaration on the authenticity of submitted materials.