On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”). Comments are due on June 20, 2016. This is the second round of clinical trial exemption catalogues since the revisions to the framework regulation, the Medical Device Supervision and Administration Regulation (“MDSAR”) was issued in 2014.
MDSAR introduced a conceptually clearer framework for applicants to determine whether their device could be exempt from the general requirement that they conduct clinical trials in China to support marketing approvals for Class II and III devices, and MDSAR required that CFDA issue catalogues of specific exempt devices to facilitate that system. The CFDA Draft Catalogues apply to both devices that are manufactured domestically in China and those that are imported. They also apply to in vitro diagnostics (“IVDs”).
China has also committed to expanding clinical trial exemptions for more medical devices as part of the bilateral dialogue with the United States, known as the Joint Commission on Commerce and Trade (“JCCT”). Specifically, during the 26th JCCT, China committed to “complete the drafting of the second batch of medical device clinical trial exemption catalogues in order to further expand the scope of the exemption catalogues” in 2016.
CFDA issued its first two clinical trial exemption catalogues in mid-2014, one for Class II devices containing 488 entries and one of Class III containing 79 entries. The CFDA Draft Catalogues expand upon that work. CFDA’s Center for Medical Device Evaluation (“CMDE Draft”), an affiliated center that organizes technical reviews of device applications, issued an earlier version of the CFDA Draft Catalogues in December of 2015. Likely based on the comments received on the CMDE Draft, the CFDA Draft Catalogues now include an additional 114 Class II medical devices and 8 more Class III medical devices.
Chinese and foreign medical device companies doing business in China should submit comments on the CFDA Draft Catalogue and continue to monitor developments for the final version.