Register for Upcoming Webinar on DEC. 8 @ 11AM

2024 China NMPA Bluebook is here:

Loading Events

Events

January 25 @ 10:00 am 11:00 am

China is re-opening to the world after COVID isolation in 2023. As the only double-digit growth country in MedTech, 2nd largest market in the world, China market entry has its challenges to enter and sustain the growth. We will review key policies, guidelines, standards, and announcements in the past and look ahead 2024. How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, impacts of PTR tests and standards change, different clinical pathway and RWD program, increased post market compliance inspections and the penalties? In addition, there is also the emerging Made-In-China policy and innovation approval to enjoy premium pricing.

  • New law, regulation, policy, standards & guidelines in 2023.
  • Leverage the latest regulations to shorten the time-consuming local type testing.
  • Latest clinical evaluation requirements: decision tree, overseas clinical data, clinical trial, CER, piloted real-world data.
  • “Made-in-China” policy to shorten time-to-market: definition, criteria, requirements and different models.
  • Green pathway to enjoy special pricing and exempt from China Volume Based Purchasing (VBP).
  • Great Bay Area & Hainan pilot policy for NMPA un-approved devices use in China.
  • Post market Surveillance and Quality Management System (UDI, NHSA code, AE, Recall and Inspection).