China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval.
Requests for predicate device performance parameters
First, NMPA has issued a notification (link in Chinese) clarifying how registrants should apply to the regulator to obtain performance parameters of appropriate predicate devices in order to produce clinical evaluation reports (CER).
According to Emergo by UL sources in Beijing and Hong Kong, the NMPA’s predecessor agency CFDA (China Food and Drug Administration) first established the process for requesting performance parameters of predicate devices in 2014, but these requirements had not been made public until now.
Once NMPA receives online requests for performance parameters, the regulator will provide the information in about two months. Chinese market applicants may then use that information in CERs to support equivalency claims between their products and predicate devices…