It is preferred to select products that have been approved for registration in China and that are basically equivalent to the product under application in terms of basic principle, structural composition, manufacturing materials, manufacturing process, performance requirements, safety evaluation, complied national/ industry standards, intended use, etc. If there is no such basically equivalent product, a product that is as similar as possible should be selected. If it is not possible to use marketed similar products for reasonable reasons, it is allowed to choose products that have been widely used clinically and have proven and recognized efficacy for the corresponding indications.
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
