Medical devices refer to instruments, equipment and instruments directly or indirectly used for human body, in vitro diagnostic reagents and materials related to calibration objects
Medical devices are classified according to the degree of risk。Categories I, II and III.
| I： | Low risk, the implementation of routine management can ensure its safe and effective medical devices |
| II： | Medical devices that pose a moderate risk and require strict control and management to ensure their safety and effectiveness |
| III： | Medical devices are of high risk and require special measures to strictly control and manage them to ensure their safety and effectiveness |
| product I | product II，III |
|---|---|
| STEP1: Business talks and contract | STEP1: Business talks and contract |
| STEP2:Document review | STEP2: Document review |
| STEP3. submit | STEP3. Test（3-12months） |
| STEP4: Issues certificates | STEP4: Audit（8-12months） |
| STEP5: Pass | |
| STEP6: Issues certificates |
