Jun 27, 2016
Chinese medical device regulators are seeking comment on a draft proposal for determining which devices qualify for the country’s high-priority review program, and in what order.
The China Food and Drug Administration (CFDA) has targeted domestic Class II devices and imported Class II and III devices in the proposal (link in Chinese); the regulator seeks to establish three review groups for determining which devices qualify for high-priority reviews.
Group 1 devices would include products that are part of China’s National Science and Technology Major Project or the National Key Technologies Research & Design Program. Reviews of Group 1 devices to determine whether they qualify for high-priority registration would take five business days.
Group 2 devices would include the following types of products:
The CFDA would convene expert panels on a monthly basis to determine which Group 2 devices qualify for high-priority review and which should undergo normal premarket review.
Group 3 devices would include other products that should be evaluated as high priority.
The CFDA first announced its high-priority review pathway in 2014 as a way to introduce innovative medical technologies into the Chinese market faster than through standard registration. While the high-priority pathway does not necessarily curtail any requirements of the standard CFDA registration process, it may nonetheless speed up review timeframes for qualifying manufacturers.
Emergo consultants in China will provide updates on the CFDA proposal in the near future.
Chinese medical device market regulators have more clearly defined the responsibilities of in-country representatives and limited exemptions for clinical evaluations in new rules, according to Emergo Group colleagues.
Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process.
CFDA Administrative Order No. 4 covers new and revised requirements for Class I, II and III device registrations in China that will take effect October 1, 2014.
The China Food and Drug Administration (CFDA) will launch an expedited registration process (link in Chinese) on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country.