The change of leading site is a major amendment, and the change application should be conducted.
Strategy Consulting
- Market Entry Strategy
- Regulatory Strategy
- Clinical Strategy
- China Localization Strategy
- Hainan Urgent Use Pathway
- Innovation Pathway
- Fast Track Pathway
- Digital Health Consulting
Registration Affairs
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- Request for Classification
- Legal Agent Representation
- NMPA Expert Panel Meeting
- NMPA Supplemental Notice
Quality Assurance
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- Adverse Event Reporting
- Recall Handling
- Periodic Risk Evaluation Report
- Annual QMS Self-Inspection Report
- NMPA Inspections & Mock-Audit
- QMS Establishment/Audit/Remediation
- QA Gap Analysis
- Factory Audit
- Unique Device Identifier
Device Testing
- China Local Type Testing
- Device Modification Compliance Testing
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Clinical Research Organization (CRO)
- Clinical Trials/Research
- Real-World Study
- China CER & MDR CER
- Clinical Evaluation Feasibility Assessment
Customized Training
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Other Services
- Translation
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