Jul 25, 2022

China’s Center for Medical Device Evaluation (CMDE) published several new pieces of guidance that medical device manufacturers doing business in the country should review to confirm continued compliance. All links below are in Chinese.

Updated compliance guidelines from CMDE for medical device safety and performance

The CMDE published new guidance to help medical device registration applicants interpret how to implement Essential Principles of Medical Device Safety and Performance, issued in March 2020. CMDE Announcement No. 29 of 2022, Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance, was created to help medical device manufacturers integrate the requirements of the regulation into the development and manufacture of medical devices. Notably, the guidelines identify applicable products and methods to demonstrate compliance for each section of the Essential Principles.

CMDE outlines recommended paths for clinical evaluation of certain devices

The CMDE published additional documents that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. CMDE Announcement No. 30 of 2022, Recommended Clinical Evaluation Paths for Certain Medical Devices, serves to guide registration applicants in determining the clinical evaluation path for the following products:

  • 01 Active Surgical Instruments
  • 04 Orthopedic Surgical Instruments
  • 07 Medical Diagnostic and Monitoring Equipment
  • 08 Respiration, Anesthesia and First Aid Devices
  • 09 Physiotherapy Equipment
  • 10 Blood Transfusion, Dialysis and Cardiopulmonary Bypass Devices
  • 19 Medical Rehabilitation Equipment
  • 21 Medical Software

For guidance on using these documents, the CMDE also published Instructions for Use of the Recommended Path for Clinical Evaluation of Related Products for each subcategory. For details, these documents are provided as attachments to CMDE Announcement No. 30 of 2022.

Emergo by UL will post updates to China’s medical device regulations as they are released.

Additional Chinese medical device regulatory resources from Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

Author

  • Kathryn Burke's picture
    Kathryn Burke

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