Bairen Medical (688198.SH): Application for registration of biological supplements for ophthalmic surgery was not approved

Zhitong Financial App News, Bairen Medical (688198.SH) issued an announcement. The company received the “Medical Device Unregistered Approval” from the State Drug Administration on September 4, 2026. The company's application for the registration of biological supplements for ophthalmic surgery was not approved by the State Drug Administration and officially announced on the official website of the State Drug Administration.

According to the opinion of the Medical Device Technical Evaluation Center of the State Drug Administration, “Registered applicants carry out clinical evaluations through the clinical trial pathway. The clinical trial used a prospective, multi-center, single-group target value design, and did not use a randomized control design; minors and adults were enrolled at the same time. Different groups had different pathophysiological characteristics, disease progression, prognosis, and risk benefits, so separate prospective multicenter randomized controlled clinical trials were required. The existing data does not support the assessment of product risk benefits, and cannot prove the safety and effectiveness of the declared product.”