The biocompatibility evaluation study of such products should pay attention to the following: the administrative counterpart should provide a biological evaluation report that meets the requirements of GB/T 16886.1 according to the intended clinical use of the products. If biological test are conducted for such products, the relevant evaluation test should be carried out in accordance with the requirement that the product is in direct contact with circulating blood and the cumulative contact duration exceeds 30 days.
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
