On March 26, the National Medical Products Administration (NMPA) approved the registration of "glaucoma drainage tube" of Allerga upon the review.
In order to promote the reform of review and approval system of medical devices in China and explore the use of clinical real-world data for the registration of medical device products, NMPA and Hainan Provincial Government jointly launched the pilot use of clinical real-world data of Hainan in June 2019. The device is the first pilot product. Clinical real-world evidence collected at the Hainan Boao Lecheng International Medical Tourism Pilot Zone was used for the evaluation of racial differences in its registration. It is the first product approved by this way in China.
The product is comprised of a drainage tube and a syringe. The drainage tube is made of pigskin gelatin and glutaraldehyde, and shall be pre-installed in the syringe. The product is applicable to open-angle glaucoma when the following four conditions are met: 1. The entrance of the chamber angle is relatively wide; 2. The use of drugs alone does not have a good effect or drugs cannot be used for treatment; 3. Laser therapy of chamber angle cannot control the disease progression, or a doctor judges that it is inappropriate or unable to carry out the laser therapy of chamber angle. 4. The traditional filtering surgery does not have a good effect or cannot be tolerated.
Medical products administrations will strengthen the post-marketing supervision of the product and effectively protect patients' safety in device use.