Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

January 10, 2018  Source: Emergo 123

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.

The regulator’s latest batch of updates includes medical device clinical trial design, in-country device testing and mobile medical devices, according to Emergo consultants in Hong Kong.

Clinical trial design guidelines

First, CFDA has issued new technical guidance (link in Chinese) for clinical trial designs. The new guidance includes information regarding selection of study endpoints, methods for calculating sample sizes and related study design considerations.

Mobile medical device registrations

Second, new technical guidance (link in Chinese) has been issued to clarify what CFDA considers mobile medical devices. According to CFDA, “mobile medical device” refers to software and equipment that utilize non-invasive mobile computing terminals such as handheld smartphones and tablets, wearables as well as commercial off-the-shelf technologies to perform medical functions.

Funding for in-country testing of medical devices

Next, a new CFDA notice (link in Chinese) was published in late 2017 for the agency’s local-level offices and device testing centers; the notice advises the following:

  • Local CFDA branches should request financial support from local governments to support registration testing activities
  • Local CFDA branches should provide support for test centers
  • Test centers should accept applications from other provinces
  • Testing timelines should be clarified and confirmed in contracts
  • Test centers should issue results within reasonable timeframes

This clarification follows a shift in CFDA policy in 2017 in which medical device registrants were no longer assessed testing fees; issues including delayed testing timeframes and some local test centers no longer accepting applications from foreign registrants have arisen since this policy shift, so the new notice may help address these discrepancies.

Additional Chinese medical device regulatory resources:

  • China FDA medical device registration and approval consulting
  • CFDA clinical and testing requirements assessment consulting
  • Medical device material and chemical characterization testing support
  • Whitepaper: China CFDA medical device registration requirements
  • Regulatory process chart: CFDA regulatory approval for medical devices
By Ddu
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