The China Food and Drug Administration (CFDA) has proposed exempting additional medium- and high-risk medical devices and in vitro diagnostic (IVD) devices from clinical trial requirements.

CFDA’s proposed exemptions would amend Order 650 (links in Chinese), and apply to 48 Class II and III medical device product names, as well as several IVD product names. Earlier in 2017, the regulator proposed clinical trial exemptions for 22 Class II devices and six Class III devices; these additional proposed exemptions suggest ongoing attempts by CFDA to loosen some Chinese market access requirements to attract more foreign medical device and IVD manufacturers.

Emergo consultants in Hong Kong are currently analyzing the proposed CFDA Order 650 changes to determine how Chinese medical device and IVD market registrants may be affected; some key issues already identified in the proposal include:

  • Increasing CFDA acceptance of clinical data obtained in other countries
  • Increasing acceptance of self-test reports from Class II and III device manufactures for Chinese registration purposes (testing at CFDA test centers is no longer mandatory)
credit: emergogroup