2020 China NMPA (CFDA) Bluebook

2020 China NMPA Blue Book: Revised Medical Device and IVD Regulations

China’s overhaul of medical device and IVD regulations could mean huge benefits to device manufacturers. Just as one example, now NMPA offers additional options for fast-track approvals and more flexible testing/clinical-trial requirements. Is your product positioned to benefit from faster and less-costly China market entry? Compared to other major markets around the world, medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China. Our 2020 version of the NMPA Bluebook, the all-in-one resource for medical devices and IVDs, provides an up-to-date overview and information on dozens of new regulations, along with clear explanations of how they could affect registration, renewal and post-market compliance for your product in China. Get it today for free ($500 value) with completion of a survey:

This 50+ page guide outlines in thorough detail NMPA regulatory changes, from Product Registration, Clinical Evaluation, Manufacturing, Labeling to Post-Market Surveillance, including:

  • How the creation of 3 new divisions under NMPA will affect your submission speed
  • What are the Revised Standards for 81 medical devices and 12 IVDs
  • How can Innovation Devices eligible for 3 new Fast-Track channels
  • What are these 171 Clinical Trial exemptions and the new procedure that could expedite your clinical trials
  • Know about these 8 GMP guidelines for Software Manufacturers
  • Get updated with these 5 major changes to Adverse Event Reporting
  • What are the trends to expect in 2020 such as Real Word Data, Market Authorization Holder system, a Complete Lifecycle Supervision approach and International Harmonization.
  • How to avoid these 11 issues cited in Overseas Inspections and why 2 manufacturers were cited for suspension
  • Last but not least, find about an extensive index of regulatory documents issued in 2019 covering Policy, Technical Guidance and Industry Standards
2020 Bluebook

The China NMPA Blue Book will help foreign medical device and diagnostic companies to overcome the barriers and to be kept informed of the Chinese regulatory system due to language and culture differences. It will be a valuable tool for overseas companies to enter China.

— Mr Gong Zhi Jun, Director Administration Institute of Executive Development NMPA