While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some defined exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says.
Devices that are demonstrated to be equivalent to ones already on the market, with equivalent safety and efficacy, may be exempted from clinical trials, under the new rules, says John Balzano, special counsel for Covington & Burling’s food and drug practice group.
Exemptions also are available for devices whose safety and effectiveness can be evaluated nonclinically and ones that can be evaluated on the basis of existing clinical data.
The China Food and Drug Administration has prepared catalogues to help devicemakers determine classification and whether exemptions apply, Balzano notes. The agency has also issued draft guidance on clinical trials guidance that, once finalized, should help firms use the exemption catalogue and compare product names, descriptions and intended uses.
While parts of the draft need clarifying, it is a step forward in terms of offering guidance, the lawyer says.
The regulations were adopted in March 2014 and took effect Oct. 1.
Before devicemakers apply to register their devices, they should perform testing to ensure that their products conform to CFDA technical requirements, says Balzano, who discussed the new regulations during an FDAnews webinar.
Firms must also determine the device’s class. Classification is a key process because it determines many requirements, such as whether a trial is necessary or if a trial must be preapproved, as is the case with certain high-risk Class III devices, Balzano notes.
Classification also determines which accredited trial site will be used for a particular type of device, Balzano says. As with preregistration testing, applicants must conduct trials at state-accredited clinical trial institutions such as state-run hospitals.