EMERGO SUMMARY OF KEY POINTS:

• The China Food and Drug Administration (CFDA) has published new technical guidance on accepting medical device clinical data from sources outside China.
• Foreign clinical data used in CFDA registration applications must meet China Good Clinical Practice requirements.
• Chinese market registrants should notify CFDA before submitting applications that they intend to use foreign clinical data in their applications.

Following the China Food and Drug Administration’s recent announcement that the regulator plans to make clinical trial requirements for foreign manufacturers of higher-risk devices and IVDs more flexible, additional information on how these changes will impact registrants has become available.

As Emergo previously reported, CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. Now, Chinese regulators have issued new draft technical guidance (link in Chinese) on acceptance criteria for clinical data obtained in other countries.

Key changes to CFDA foreign clinical data acceptance criteria

According to an Emergo analysis of the latest CFDA technical guidance, Chinese market registrants using clinical data from foreign sources in their applications must ensure that the following criteria are met:

• Foreign clinical trials must have been conducted according to China Good Clinical Practice (China GCP); any deviation from China GCP should be explained and justified.
• Foreign clinical data may be used as clinical study data for devices that would undergo the clinical trial route in China, or as a verification source for substantial equivalence to a predicate device under the Clinical Evaluation Report (CER) route.
• CFDA reviewers will focus on differences in clinical evaluation requirements (selected clinical study endpoints, for example), ethnicity (data should apply to Chinese populations) and clinical trial conditions such as intended user populations.

Chinese market registrants should also discuss plans to use clinical data from foreign sources with CFDA before submitting their applications to the regulator. However, no standard process for setting up pre-submission consultations with CFDA is currently in place.

Additional clinical changes proposed by CFDA

Emergo consultants have examined proposed Order 650 amendments and related clinical trial requirement changes to identify additional issues affecting CFDA registrants. Such issues include:

• Foreign CFDA registrants’ local agents will have to assume liability for devices on the Chinese market, as well as responsibility for adverse event reporting to Chinese regulators.
• CFDA will no longer require home-country approval for imported products that qualify as innovative medical devices.
• Test reports required for Chinese registration will not have to be issued by CFDA testing labs; self-test reports will also be acceptable.

Related CFDA resources from Emergo:

• China FDA registration consulting for medical device companies
• CFDA clinical and testing requirements assessment
• Whitepaper: CFDA medical device registration requirements
• Video overview: China’s medical device market