Mar 24, 2016

The China Food and Drug Administration (CFDA) plans to begin enforcing new clinical trial quality management requirements for medical devices starting June 1, 2016.

Applicable to medical devices but not IVDs, the new guidelines pertain to all clinical studies for safety and effectiveness of products submitted for CFDA registration. China’s previous rules for clinical trials under the Provision on Medical Device Trials of 2004 will be replaced by these new requirements.

The new guidelines (link in Chinese) include the following provisions that China medical device market registrants should be aware of:

  • Sponsors should complete all pre-trial testing such as CFDA registration testing before conducting actual clinical trials; pre-trial test reports should be issued no later than one year prior to beginning a clinical trial.
  • Devices that have not been cleared or approved for sale in other markets before CFDA registration must undergo feasibility studies with small sample sizes in order to verify safety and efficacy.
  • Foreign-based sponsors must appoint a Chinese Agent to liaise with the CFDA on their behalf.

To be sure, the new clinical trial quality system requirements do more to codify what CFDA officials have had in place over the past few years than to introduce altogether new requirements, according to Emergo consultants in China. High-level clinical trial requirements had been included in CFDA Order 650 published in 2014, but now Chinese regulators have provided more details on their formalized clinical trial process.

Bottom line: New CFDA guidelines are more of an upgrade to China’s 2004 Provision on Medical Device Trials than an introduction of new requirements. Nonetheless, CFDA medical device registrants should note that these rules will soon be officially codified and enforced.

To learn more about medical device registration and approval in China, see our regulatory process chart.


  • Stewart Eisenhart