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2024 China NMPA (CFDA) Bluebook

2024 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 2024 annual NMPA (CFDA) Blue Book provides with a snapshot of 2023 changes and impacts on 2024.

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  • This 80+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements:
  • The NMPA issued a notice on January 18, 2023, highlighting the significance of the Medical Device Master File system in protecting intellectual property rights for medical device raw materials. 
  • China’s Ministry of Science and Technology issued the “Details for the Implementation of the Human Genetic Resources Regulations” on June 1, 2023, building upon regulations effective since July 1, 2019. The guidelines simplify licensing applications and specify requirements for international research, clinical trials, information provision, and data management related to human genetic resources.
  • NMPA announced on August 21, 2023, the reclassification of certain neurosurgical, cardiac surgery, orthopedic, hemodialysis, and radiological devices, aiming to expedite market entry for needed devices. Notable changes include down-classifying devices from Class III to Class II.
  • On October 11, 2023, NMPA issued a notice for the second round of feedback on the “Guideline on Medical Device Human Factors Design,” following the initial draft released in May 2020. This guideline specifies the human factors design and usability engineering of Class II and III medical devices, excluding in vitro diagnostic reagents. 
  • On July 18, 2023, the NMPA released the “Medical Device Benefit-risk Assessment Guideline (2023 revised version),” aiming to enhance the predictability, consistency, and transparency of the pre-market review process. 
  • Addressing medical electrical standards, the NMPA implemented the “Notice on Implementation of GB 9706.1-2020 and Supporting Standards” on March 16, 2023, with a grace period for compliance until December 31, 2025.  
  • NMPA Recognized Innovative Devices: 61 innovative devices
    have been recognized in the NMPA 2023 Innovation Approval Notices. 
  • Another pivotal development was the release of the “Guideline on Medical Device Real-world Study Design and Statistical Analysis (Draft)” on September 28, 2023, signaling a direction towards real-world evidence generation, particularly through pragmatic randomized controlled trials. 
  • In March 2023, the NMPA unveiled the “2023 National Inspection Plan for Medical Devices,” instructing provincial MPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs). 
  • In March 2023, the NMPA unveiled the “2023 National Inspection Plan for Medical Devices,” instructing provincial MPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs). 
  • …… 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

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