To successfully obtain the NMPA approval, one must provide an indication for your product that the NMPA reviewer can accept. As a foreign product, the NMPA reviewer usually asks you to provide the same indication as your home country’s approval. For example, a device using US FDA as home country clearance/approval shall not submit indications using for European approval unless the US and EU indications are the same, or the EU indication is more accurate than the US indication. NMPA reviewer does not accept indication that is out of the scope of your home country approval.
Takeaway: Green Innovation Registration Pathway does not require home country approval for the products
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
