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2024 China NMPA Bluebook is here:

2023 China NMPA (CFDA) Bluebook

2023 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 2023 annual NMPA (CFDA) Blue Book provides with a snapshot of 2022 changes and impacts on 2023.

Get it today with the completion of survey below:

This 80+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements:

  • 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.
  • NMPA released eleven submission filing review guidelines, which are equivalent to FDA’s Acceptance and Filing Reviews, on September 1, 2022, to provide a more stringent guide for applicants during the technical review process for medical devices, as well as IVDs. 
  • To be more dynamically adapting to the market needs to introduce needed device to the China market faster, the NMPA has released announcements on reclassification and modifications of intended uses for certain neurosurgical, cardiac surgery, aesthetic, analytical, ortho and dental medical devices on March 24 and March 30, 2022. 
  • NMPA released the “Guideline on Writing Medical Device Product Technical requirements (PTRs)” on February 9, 2022, guiding manufacturers on preparing the PTR, one of the most important documents in its submission to NMPA.
  • NMPA issued the “2022 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. NMPA finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, in which 86 medical devices and IVDs are affected. 
  • NMPA and China Health Commission released the “Norms on the Quality Management for the Clinical Trials of Medical Devices (China GCP)”, effective May 1, 2022. 
  • NMPA issued the “Guideline on Inspection of Quality Management System for Medical Device Registration” on October 10, 2022, intended to provide general requirements in different types of inspection, including registration, self, commissioned, and extended inspection, etc. 
  • NMPA announced modifications to 27 medical devices’ classification catalog on March 30, 2022, among which 16 were cosmetic related. Starting from April 1, 2024, certain cosmetic devices should not be produced, imported or sold without medical device registration certificate obtained.
  • …… 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