The National Medical Products Administration (NMPA) of China has recently expanded the list of medical devices exempted from providing locally generated clinical trial data and allowed the use of real-world data for medical device registration. These steps will encourage foreign medical device manufacturers to access the Chinese market as the new process will reduce registration cost and the time to market a device in China, says GlobalData, a leading data and analytics company.

GlobalData’s research reveals that the China medical devices market, which accounted for more than 30% of the Asia-Pacific medical devices market in 2019, is expected to grow at a compound annual growth rate (CAGR) of 5.6% through 2025. 

Rohit Anand, Medical Devices Analyst at GlobalData, comments: “Many foreign medical device manufacturers postponed or canceled plans to supply devices in China after the country amended regulatory process in 2014, making it mandatory for majority of Class 2 and all Class 3 devices to undergo clinical trials locally. This had resulted in an exorbitant cost and an extended timeline for market entry.”

NMPA has recently approved Allergan’s Xen glaucoma treatment system comprised of gel stent and injector through real-world data (RWD) program for the surgical management of patients with refractory glaucoma. The real-world data collected in China was used to ‘evaluate ethnical differences’ of the glaucoma treatment system. Controlled clinical trials data conducted outside China should be used with the real-world evidence data for device approval under this program.    

Anand concludes: “The use of real-world data to get medical device approval is a major reform for the medical device approval process in China and may become a major clinical pathway to get device approval in the future. The successful launch of Xen glaucoma treatment system by Allergan is an encouraging sign for companies waiting to lauch their medial devices in China.

“This process will also reduce the associated costs to conduct clinical trials in China and reduce the time to bring a device into the market. Additionally, it will help the country to procure urgently needed medical devices in case of healthcare emergencies.”