China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements

EMERGO SUMMARY OF KEY POINTS:

• CFDA has proposed adding more Class II and III medical devices and IVDs to its clinical trial exemption list.
• The regulator has already exempted more than 300 Class II and about 100 Class III devices from clinical trial requirements.
• CFDA registrants qualifying for these exemptions may submit clinical data obtained outside China for market application purposes.

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)

Additional Chinese medical device regulatory resources from Emergo:

• CFDA medical device registration and approval consulting
• CFDA clinical and testing requirements assessment
• Clinical trial data management consulting and support
• Whitepaper: CFDA medical device registration requirements
• Video overview: Chinese medical device market access