2023 China NMPA (CFDA) Bluebook

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