Accel

China Green Pathways: Expedite Your Market Entry in China
2023-12-23 08:00 - 17:00 (America/New_York) | China Med Device, LLC, United States
China NMPA created several special fast-track registration channels for medical devices. To further encourage innovation, China announced recently that approved innovative products can enjoy special pricing with higher premium enjoy reimbursement and exempt from China Volume-based Purchasing (VBP). China is the 2nd largest MedTech market and the only country with continuous double-digit growth. How can overseas companies benefit from accessing the China market faster with these special pathways?
Innovation is one of the pre-market submission pathways with equal opportunity for both overseas and domestic manufacturers. In addition, there are other special pathways.
This session will address the topics of:

Overview of green pathways
Criteria and requirements of innovation pathway
Innovation special review dossier process
Advantages and consideration of fast-track channel: traditional vs. innovation pathway
Benefit of innovative products in VBP, pricing and reimbursement

Free

Online via Microsoft Team

Understanding IVD Reagents Registration Requirements: China & US Perspectives
2023-11-07 10:00 - 11:30 UTC
Join our webinar to stay up to date on the changing regulatory landscape in both China NMPA and US FDA for In Vitro Diagnostics (IVD) reagents. Our expert speakers will explore the key requirements, processes, and approval criteria for reagent products in these 2 largest Medtech markets in the world.
After this 75-minute webinar you will have a practical understanding of the following areas about IVD reagents registration:
China NMPA

General regulatory landscape of IVD reagents
Specific IVD classification rules and registration unit division
Registration dossier requirements and best practices
Significant NMPA requirements that you need to comply for your type testing success
Using Overseas Clinical Trial Data for China submission
Regulation on human genetic resources for clinical studies

US FDA

FDA risk classification for IVDs
Requirements for registration and listings of IVD products
510K exempt devices
Concept of general controls
Special controls and pre-market approval
