Jun 13, 2022

Several new guidelines have been announced by medical device market regulators in China.

First, the Chinese National Medical Product Administration (NMPA) released updates regarding rules for clinical trials of medical devices and IVD reagents conducted for the purpose of device registration.

Second, the Center for Medical Device Evaluation (CMDE) published device-specific guidelines including Registration Review Guidelines for Intravascular Guidewires. In addition, the CMDE published Guidelines for Stability Studies of Passive Implantable Medical Devices, 2022 Revision.

NMPA revises Medical Device Clinical Trial Quality Management Regulation

The NMPA released the revised Medical Device Clinical Trial Quality Management Regulation, effective May 1, 2022. This revision is intended to regulate clinical trials of medical devices and IVD reagents that are conducted for the purpose of device registration with the NMPA. The NMPA also issued Announcement No. 21 of 2022 to specify details for the implementation of the revised regulation. It replaces the prior NMPA Order No. 25, published in March 2016.

The revision adjusts the overall framework of the regulation and:

  • Revises requirements for IVD reagents
  • Modifies the safety information reporting process
  • Simplifies some requirements and harmonizes with other global regulatory requirements

Details are provided in the attachment to Announcement No. 28 of 2022 and in the accompanying Interpretation of Medical Device Clinical Trial Quality Management Regulation.

CMDE publishes various guidelines and technical review points

China’s CMDE published several device-specific guidelines. The Registration Review Guidelines for Intravascular Guidewires (Announcement No. 11 of 2022) were published in order to strengthen the management of intravascular guide wires.

Guidelines for Stability Studies of Passive Implantable Medical Devices (2022 Revision) (Announcement No. 12 of 2022) were published in order to further strengthen the management of the stability research of passive implantable medical devices.

All links above and their attached annexes are in Chinese.

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

Learn more about complying with China’s medical device regulations 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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