I would say this is one section required to be included in the CER; you don’t need to create a stand-alone report. You still need the state of the art.
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
- Pre-market Registration
- Modification Registration
- Renewal Registration
- Request for Classification
- Legal Agent Representation
- NMPA Expert Panel Meeting
- NMPA Supplemental Notice
Quality Assurance
- Postmarket Surveillance Compliance (IFU, Label, GSP)
- 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
- Biocompatibility Testing
- EMC Testing
Clinical Research Organization (CRO)
- Clinical Trials/Research
- Real-World Study
- China CER & MDR CER
- Clinical Evaluation Feasibility Assessment
Customized Training
- China Regulatory Training
- China QMS Training
- China GCP Training
- China Localization Training
- Periodic Regulatory Updates Training
Other Services
- Translation
- Patent & Trademark
- Distributor Evaluation & Audit
- KOL Interview/Consultation
- Investment
- Global regulatory services
