Data released by China’s National Medical Products Administration (NMPA) on May 31 showed a steep decline in the registration of new medical devices in 2018. The 25 percent decline between December 2017 and December 2018 sunk the overall medical device registration numbers to their lowest since 2013, when China first began publishing registration data. The declines in approval rates come amid efforts by the government to update and improve its regulatory system.
According to the report, 5,528 initial registrations, registration renewals, and registration changes were approved by NMPA in 2018. The year before, more than 8,500 total registrations were approved. The declines were spread across the majority of registration categories and medical device classifications, according to the report.
The declines were driven by drops in several areas—a nine percent decrease in approval rates for imported Class III devices and a 59 percent drop in approved renewals. More than 40 percent of registrations approved during the year were for licensing changes, perhaps reflecting an increase in the number of medical devices already registered for use in China.