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2018 Annual Report for Medical Device Registration Released

CCFDIE|Updated: 2019-07-06

On May 31, 2019, NMPA issued the 2018 Annual Report for Medical Device Registration, which consists of five parts, namely, the situation of medical device registration; the acceptance of medical device registration applications; review and approval of medical device registration; review and approval of registration for innovative medical devices and other products; and management of other registration affairs. The statistics period of this Report spans from January 1, 2018 to December 31, 2018.

for medical devices, decreased by 3.3% as compared with that in 2017.

In 2018, NMPA approved a total of 5,528 items of medical device initial registrations, registration renewals and registration of changes. Compared with 2017, the total number of registration approvals is down by 38.0%. Among them, 1,128 were for initial registrations, 2,150 were for registration renewals, and 2,250 were for registration of changes in licensing items.

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Among them, in 2018, within its purview, NMPA accepted 6608 applications for initial registration, registration renewal and registration  of  changes in  licensing items.

In 2018, NMPA has rejected a total of 118 medical device registration applications, while 238 applications were voluntarily withdrawn by the enterprises.