Interactive Tool: China NMPA Medical Device & IVD Clinical Trial Assessment

Planning your regulatory route into China? One of the biggest factors impacting your timeline and budget is whether China's National Medical Products Administration (NMPA) will require local clinical trials for your medical device or IVD.

This interactive assessment tool is designed to give you a quick, preliminary evaluation of your clinical trial requirements in China. Simply answer a few brief questions about your product, predicate availability, and existing evidence to instantly view your preliminary assessment.

Once completed, you can share your results directly with our experts to receive a tailored strategy for your NMPA medical device registration.

*Disclaimer: This tool provides a preliminary, informational assessment based on user-provided inputs. It does not constitute formal regulatory advice or a guarantee of any NMPA registration outcome.

Take the Next Step in Your NMPA Strategy

While this assessment offers a quick preliminary snapshot, navigating China's clinical evaluation requirements often involves complex technical nuances. Whether your product qualifies for a Clinical Trial Exemption, requires local clinical trials, or qualifies for an alternative pathway, Cisema can help you chart the fastest, most cost-effective path to market.

Backed by over 20 years of on-the-ground experience in China, our team provides comprehensive regulatory support, including:

• Product Gap Analysis: Thorough comparison of your device against registered predicates in China.
  
• CER & PER Preparation: Expert compilation of Clinical and Performance Evaluation Reports.
  
• Overseas Data Evaluation: Assessment of non-China clinical studies to meet NMPA ethnic variance and GCP requirements.
  
• Full-Service CRO Support: In-country trial management, site selection, and protocol design if local medical device clinical studies are required.

To discuss your medical device portfolio and accelerate your entry into the Chinese market, contact Cisema today.

Further Information

Explore Cisema's China Medical Device CRO & NMPA Clinical Trial services.

Read more about medical device clinical trials in China:

• When Is a Clinical Trial Required for China NMPA Medical Device Registration?
• How China Medical Device Clinical Trial Strategy Affects NMPA Approval Timelines
• A Guide to China Medical Device GCP Compliance
• How China Medical Device Clinical Trial Strategy Affects NMPA Approval Timelines
• 9 Key Terms: China Medical Device & IVD Clinical Trials