By Stewart Eisenhart, Emergo Group
Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago.
According to US representatives at the 25th US-China Joint Commission on Commerce and Trade, less cumbersome registration pathways in China would provide a boon to US manufacturers exporting their devices to the country. (US device exports to China totaled $2.7 billion in 2013.) Faster market authorization timeframes would also provide faster access to innovative medical products and technologies for the Chinese population, stated the officials.
Three points of consensus pertaining to Chinese medical device and pharmaceutical registration processes make up the agreement:
- The China Food and Drug Administration (CFDA) will fast-track assessments of how to speed up the regulator’s approval systems for medical devices and drugs
- Registration applicants using Multi-Regional Clinical Trial data that includes data obtained in China and whose submitted materials comply with technical review requirements may apply for and obtain clinical trial waivers for their devices in China
- Devices and drugs undergoing clinical trials in other markets may also undergo clinical trials in China on a concurrent basis
Chinese officials have additionally agreed to expand the CFDA’s list of clinical trial product exemption catalogues, as well as expand the scope of devices exempted from clinical trial requirements in China. No firm timeline has been set for implementation of less strict requirements, but the potential for faster Chinese market access once the new agreements come to fruition should not be lost on affected US manufacturers.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
