Apr 1, 2018

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) is being reorganized into a new agency.
  • A new State Administration for Market Supervision take over management of the regulatory agency from the Chinese State Council.
  • Emergo consultants are still determining whether and how the Chinese regulatory reorganization will affect medical device registrants.

The Chinese government has reorganized its medical device and pharmaceutical regulatory oversight structures, but the effects of this restructuring for device registrants in China remain to be determined.

According Emergo sources in Guangzhou and Hong Kong, a series of Chinese government agency restructurings includes changes to the China Food and Drug Administration (CFDA):

  • CFDA will no longer regulate food and be renamed 
  • A new entity, the State Administration for Market Supervision or SAMS, will oversee the CFDA successor agency, not the China State Council
  • City-level CFDA successor divisions will cease operation; reglatory offices will be run only on the provincial level

By refining the CFDA successor agency's focus to medical device and drug oversight, Chinese regulators should be able to utilize resources as well as address market registration reviews more effectively. By consolidating offices at the provincial level, officials should also be able to apply policies more consistently.

The Chinese regulatory restructuring is expected to occur by March 2019.

Emergo by UL will continue monitoring the situation to determine how Chinese medical device market registrants will be impacted by these regulatory changes.

Additional Chinese medical device regulatory resources: