Mar 8, 2021

China’s National Medical Products Administration (NMPA) and its Center for Medical Device Evaluation (CMDE) recently published annual reports summarizing regulatory activities in 2020. Both of these reports reflect an active year, with regulatory bodies and medical device manufacturers scrambling to respond to the impact of the COVID-19 pandemic.

CMDE publishes annual report on medical device and IVD registration activities

The CMDE released the 2020 Medical Device Registration Work Report (links in Chinese), which details medical device and IVD registration activities throughout the past year. Out of the 10,579 registration applications accepted (for initial registration, renewal, and technical changes), the NMPA approved 9,849, 16.3% more than were approved in 2019. Notably, 6,246 of the approved applications were for imported medical devices, showing an 18% increase from 2019. Registration activities related to the COVID-19 emergency response and innovative medical devices are also highlighted in the report.

NMPA report details new medical device standards introduced in 2020

The NMPA also published the China Medical Device Standards Management Annual Report (2020), which summarizes its activities and progress in the area of medical device standards. The report shows that the NMPA issued 29 mandatory standards last year (18 National Standards and 11 Industry Standards), along with numerous voluntary standards, bringing the total number of medical device standards to 1,758 as of December 31, 2020. The report provides lists of the National Standards, Industry Standards, Industry Standard amendments, and projects released in 2020, all included as attachments to the report.

The report also shows the NMPA initiating the development of key standards to respond to the COVID-19 public health emergency. The voluntary Industry Standard Technical Requirements for Reusable Medical Protective Clothing (YY/T 1799-2020) was completed, and several other standards intended for the COVID-19 response are currently underway.

More China medical device and IVD 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

  • Timothy Herr

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