On May 19, 2015, the China Food and Drug Administration
("CFDA") unveiled the Technical Guideline Governing
Medical Device Clinical Evaluation ("Guideline").
The long-awaited Guideline explains the methodology for clinical
evaluation and elaborates the conditions for clinical study waivers
under the 2014 revised Regulations on the Supervision and
Management of the Medical Devices (also known as Order #650).
Medical device manufacturers are advised to carefully review the
Guideline and analyze the implications for their product
registrations in China.
The Guideline governs the clinical evaluation of Class II and
Class III devices (excluding in-vitro diagnostic reagents), a
mandatory component of technical reviews under Order #650. The
applicant is expected to demonstrate through a comprehensive
evaluation of clinical literature, empirical data and clinical
study data that (i) the device can achieve its intended function
under normal conditions of use; (ii) the benefits of the device
outweigh the risks; and (iii) the clinical performance and safety
of the device are supported by adequate evidence.
Pursuant to the Guideline, a clinical study waiver is possible
if the device under review is proven to be "equivalent"
to a device listed in the CFDA's List of Devices Exempted
from Clinical Studies. Alternatively, if the device under
review is deemed "basically equivalent" to the same type
of devices previously approved by the CFDA, the applicant can also
waive the clinical study of its own device by using the clinical
study and empirical data derived from the previously approved
equivalent devices. Two devices are deemed "basically
equivalent" if differences in their operating principles,
structures, materials (for active devices, this applies tomaterials
that come into contact with humans), production processes, safety
evaluation, applicable national/industry standards, and intended
use do not cause a negative impact on product safety and
With respect to the clinical study requirement for imported
devices, the applicant may reference foreign study data, provided
that (i) the study design meets CFDA's requirements for
in-country registration studies (e.g., minimum sample size,
selection of the control group, study end point, and outcome of
therapeutic effects) and (ii) the applicants can present data
showing no ethnicity differences. However, an in-country
registration study on Chinese patients is mandatory for any devices
listed in the List of Class III Devices subject to Clinical
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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