On March 26, the NMPA reviewed and approved the registration of XEN Glaucoma treatment system of the US Allergen Company.

In order to promote the reform of China’s medical device evaluation and approval system and explore the use of real-world data for medical device registration, the NMPA and the Hainan Provincial Government jointly launched the pilot program of real-world application in Hainan in June 2019. This product was the first pilot product. In the registration, the real-world evidence collected in the Lecheng Pilot Zone was used for racial difference evaluation, which was the first product approved through this channel in China.

The product is composed of two parts, namely drainage tube and syringe. The drainage tube is made of pork skin gelatin and glutaraldehyde and preinstalled in the syringe, suitable for open angle glaucoma that meets the following four conditions: 1. With a wide anterior chamber angle; 2. With poor medication effect or cannot use drugs; 3. Anterior chamber laser treatment cannot control the disease progression, or doctors do not suggest anterior chamber laser treatment; 4. The effect of traditional filtering surgery is poor or intolerant.

Medical product regulatory authorities will strengthen the post-marketing supervision of the product to effectively protect the safety of patients in using the medical device.