2018 China Medical Device Approval Statistics

06/20/2019

The Chinese National Medical Products Administration (NMPA) has published some new data regarding device approvals:


Key NMPA report findings:

  • 38% decline in medical device registrations approvals yoy
  • 5,528 initial registrations, registration renewals and change registrations were approved, lowest number of approvals in five years.
  • Approval rates fell across nearly all registration categories and for all medical device classifications, according to the report.
  • More than 40% of registrations approved licensing changes
  • Class II medical devices imported from other countries saw a three-percent increase between 2017 and 2018;
  • 18% of imported devices were first-time device registrations
  • 40% of first time registrations were Class III devices
  • Approvals of imported Class III devices decreased more than nine percent from 2017 to 2018.

Behind Lower Registration Approval Rates

Regulatory changes in China also appears to be affecting foreign medical device and IVD manufacturers' commercialization plans.

Learn more about Chinese medical device and IVD regulatory issues at Zi-Medical including:

  • China NMPA medical device registration and approval consulting
  • Certificate of Free Sale (CFS) support for medical device exports
  • Whitepaper: China NMPA medical device registration requirements
  • Regulatory process chart: China NMPA medical device regulatory approval