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 Technical report of products.
5 Risk analysis report.
6 Applicable Product standard and compiling declaration(two copyies)
7 Performance Self-testing report of products.
8 Registration test report of procuts issued by the Medical Devices test organization.
9 Clinical data of Mediacal Devices.
10 Instructions for use (User manual) of Medical Devices.
11 Effective certificate documents of Quality system appraisal of production of products.
12 Authorization of Agent,Commitment of Agent and Business license of Agent.
13 Authorization of After-Sale Services organization,Commitment of After-Sale service organization and Business license of After-sale service organization.
14 Declaration on the authenticity of submitted materials.