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法规标准
content
Registration work flow
2024-08-12
graphic expression:
necessary procedure
potential involved procedures
Registration work flow
Pre-submission
Consultation
Medical Devices
Classification
Testing
Products listed In Catalogue of Medical Devices Exempted from Clinical Trials
Comparison with Predicate Medical Device
Clinical
Evaluation
Innovative
Medical Device
Review and
Emergency review
Clinical Trials
Review and Approval
Acceptance of
Registration
Application
Priority
Evaluation
and Approval
Processes
Supplementary
Expert
consultation
meeting
Consultation
after
Supplementary
Rejected Registration
and
Initiative Revocation
of Registration
Application
Issuing of
Certificates
Changes to
Registration
Renewal
Notification on
Instruction for
Use Changes
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