China: NMPA highlights accelerated reviews after bumper year for device registrations

15-01-2019

China: NMPA highlights accelerated reviews after bumper year for device registrations

(Source: RAPS 2019-01-16)

China has highlighted the impact of its special review channel following a bumper year for medical device registrations. The National Medical Products Administration (NMPA) registered 21 devices via the channel last year, almost twice as many as in 2017, and shaved months off their review times.

The number of devices registered under the special review channel, which handles breakthrough medical technologies, rose slowly in the years following its introduction, growing from nine in 2015 to 12 in 2017. The rate of uptake changed in 2018 when NMPA registered 21 devices, increasing the number of products to come to market via the channel by more than 60% in a single year.

Chinese authorities created the special review channel to get breakthrough medical devices onto the market sooner. The characteristics of the devices registered via the channel and data on their review times suggests the initiative is working as intended.

According to the Center for Medical Device Evaluation (CMDE), products processed via the special channel were on average reviewed 83 days faster than other technologies that came to market for the first time. Devices that benefited from these accelerated reviews include vagus nerve stimulation implants and positron emission tomography imaging systems.

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