EMERGO SUMMARY OF KEY POINTS:

• CFDA inspections of medical device clinical trial sites will begin in the near future.
• CFDA inspectors will be examining traceability and authenticity of clinical data.
• Clinical trial sponsors and institutions will be notified prior to on-site inspections.

The China Food and Drug Administration (CFDA) plans to begin conducting on-site inspections of clinical trials for medical devices in an effort to improve clinical data used in premarket review decisions.

According to a CFDA notice (link in Chinese), the regulator is currently forming inspection teams that will assess medical device clinical trial sites in China to verify sponsors’ compliance with regulations and protocols. The inspections will focus on registrations applications that are currently under CFDA review, for which clinical trials started prior to June 1, 2017. Inspection teams are expected to be established by late July 2017.

How the clinical trial inspection process will work

The inspection will be based on “Medical Device Clinical Trial On-site Inspection Procedure (Attachment 2 of CFDA Order No. 98 [2016] (link in Chinese)).” On-site inspections will be prioritized based on individual devices’ risk profiles and any related product complaints, according to the notice. The CFDA will notify clinical trial sponsors and institutions in writing ahead of inspections. 

What CFDA inspectors will be assessing

CFDA inspection teams will seek to verify that medical device and IVD clinical trial sites are generating traceable and authentic data to support Chinese market authorization approvals, and that the studies are conducted according to Good Clinical Practices and other related clinical trial regulations. Before CFDA publishes the list of applications to be inspected, Chinese market registrants will have the option to withdraw their registration applications rather than undergo official rejection from the regulator. In cases where inspections result in clinical data compliance issues or problems, the clinical trial sponsors and sites will face penalties according to CFDA regulation, and their registrations may be rejected.

Related Chinese medical device regulatory resources:

• CFDA registration support for medical device companies
• CFDA clinical and testing assessment support
• China medical device regulatory process chart
• Video overview: Chinese medical device market