China medical device QA/RA blog

News and commentary on regulatory changes.

China FDA Reorganization: Impact for medical device registrants

EMERGO SUMMARY OF KEY POINTS:

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

China CFDA to be reorganized as China Drug Administration for medical device regulation 2018The 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 China Drug Administration (CDA)
  • A new entity, the State Administration for Market Supervision or SAMS, will oversee CDA, not the China State Council
  • City-level CDA divisions will cease operation; CDA offices will be run only on the provincial level

By refining the CDA’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, CDA officials should also be able to apply policies more consistently.

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

Emergo 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:

 

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