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 Market Approval Certificate of Medical Devices approved or authorized by the Medical Devices Competent Administrative Department of Overseas Government.
5 Applicable Product standard and compiling declaration(two copyies)
6 Instructions for use (User manual) of Medical Devices.
7 Registration test report of procuts issued by the Medical Devices test organization(Adapting for the Class II and III Medical Devices)
8 Clinical data of Medical Devices
9 Product Quality Guaranty issued by the Manufacturers.
10 Authorization of Agent,Commitment of Agent and Business license of Agent.
11 Authorization of After-Sale Services organization,Commitment of After-Sale service organization and Business license of After-sale service organization.
12 Declaration on the authenticity of submitted materials.