Register for Upcoming Webinar on DEC. 8 @ 11AM

New white paper available now!

2022 China NMPA (CFDA) Bluebook

2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulations

China’s overhaul of medical device and IVD regulations could mean huge benefits. Manufacturers have additional options for fast-track approvals and more flexible testing / clinical-evaluation pathway requirements. Is your company positioned to benefit from a faster and less-costly market entry?

Medical devices and IVD manufacturers are facing a vastly different regulatory landscape in China today. This 2022 annual NMPA (CFDA) Blue Book provides with a snapshot of 2021 changes and impacts on 2022.

Get it today with the completion of survey below:

This 70+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements:

  • “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released as part of the China NMPA continuous regulatory reform.
  • Two pilot zones for NMPA unapproved devices – Hainan & Great Bay Area (GBA) continue to improve its special policies to allow unapproved medical devices to be clinically used in these areas more effectively.
  • To be more dynamically adapting to the market needs to introduce needed device to the market faster, within a year, the NMPA has consolidated requests for feedback about the reclassification for 31 medical devices.
  • The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application, and change & renewal applications.
  • NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected.
  • Innovative devices or those that address unmet healthcare needs, may be eligible for one of three fast-track channels.
  • NMPA published “Medical Device Clinical Trial Quality Management Measures (draft)”, the China GCP, on May 7, 2021.
  • The old “Clinical Trial Exempt Catalog” is replaced by the new “Clinical Evaluation Catalog” after Order 739.
  • NMPA released eight clinical guidelines to support the new State Order 739 to cover the full spectrum of clinical requirements for China NMPA submissions.
  • The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing.
  • The NMPA published the “Checkpoints for Medical Device Registrants and Filers Conducting Adverse Event Monitoring” on April 9, 2021, directing the manufacturers for quality management system inspection and adverse event monitoring.
  • ……. And a lot more

For a 15 minute complimentary consultation on the impacts of these changes to your business, please indicate it when you submit your survey.

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