First Medical Device NMPA Approval for Real-world Data Application

On 26.03.2020, the NMPA (National Medical Products Administration) approved the US firm Allergan’s glaucoma drainage tube, the first imported medical device registered with the support of real-world data to register in China.

The NMPA and the Food and Drug Administration of Hainan launched the pilot scheme in June 2019 to explore the applicability of real-world data in the approval system of medical devices. Allergan’s glaucoma drainage tube was the scheme’s first product, and the product’s real-world evidence was collected in Hainan’s Boao Lecheng International Medical Tourism Pilot Zone to evaluate the differences in effectiveness when the product was treated on local Chinese.

Following the first successful registration approval, the NMPA will further strengthen the post-market surveillance system to ensure the safe use of the approved device.