2019年 6月 4日
China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval.
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.
Second, NMPA plans to fully implement an electronic medical device registration management system, the eRPS system (link in Chinese) on June 24, 2019. manufacturers may use eRPS for initial registration, renewal and modification submissions for certain devices: domestic Class III devices and imported Class II and III devices.
In addition, eRPS will be used for electronic applications related to clinical trial approvals, Indications for Use change notifications and other regulatory review processes.
Finally, Chinese regulators have published new technical review guidelines (link in Chinese) for device types including synthetic resin teeth, intra-uterine devices and implantable drug delivery devices. These guidelines explain technical data China registration applicants should provide in their submissions to NMPA reviewers.