Overseas Medical Devices Initial registration which have not obtained the Marketing approval of Overseas Medical Devices

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 Applicable Product standard and compiling declaration(two copyies)

5 The whole performance test reports of products.

6 Statement for present resources condition and quality management capability(Including the test methods)of products of manufacturers.

7 Instructions for use (User manual) of Medical Devices.

8 Authorization of Agent,Commitment of Agent and Business license of Agent.

9 Authorization of After-Sale Services organization,Commitment of After-Sale service organization and Business license of After-sale service organization.

10 Declaration on the authenticity of submitted materials.