China's First Medical Device Approved for Marketing by Using Domestic Clinical Real-World Data

On March 26 ^th , 2020, the NMPA approved the registration of “Glaucoma Drainage Tube” product from Allergan, Inc.

In order to promote the reform of China's medical device review and approval system and explore the use of clinical real-world data for the registration of medical device product, in June 2019, the NMPA and the Hainan Provincial Government jointly launched the pilot project of Hainan clinical real-world data application.

This product is the first product to be piloted. In the registration, clinical real-world evidence collected in the Boao Lecheng Pioneer District in Hainan was used to evaluate the racial differences, making it the first product approved in China through this route.

This product is composed of a drainage tube and a syringe. The drainage tube is made of pigskin gelatin and glutaraldehyde and is pre-installed in the syringe. It is suitable for open-angle glaucoma that meets the following 4 conditions:

1. The entrance of the anterior chamber angle is wide;

2. Medication does not work well or cannot be used;

3. Anterior chamber angle laser treatment cannot control the progress of the condition, or the doctor judges that it is not appropriate or impossible to perform angle laser treatment;

4. Traditional filtering surgery is ineffective or intolerable.