March 17, 2025
By Dwight Akerman, OD, MBA, FAAO, AAO Dipl, FBCLA, FIACLE
Photo Credit: Getty Images
The JAMA Ophthalmology Viewpoint article “Red Light Therapy for Myopia — Current Regulatory Changes in China” by Ya Xing Wang, Ningli Wang, and Tien Yin Wong provides a comprehensive overview of recent developments regarding red light therapy as a treatment for myopia in children and adolescents. The authors discuss the device’s origin, clinical applications, safety profiles, and the changing regulatory landscape in China.
Among the various strategies to prevent the development of myopia and slow its progression, repeated low-level red light (RLRL) therapy has emerged as a popular yet controversial option. RLRL is a non-pharmaceutical treatment for children that involves exposing the retina to a red light laser (635-650 nm) for a few minutes, typically twice a day for five to seven days a week. Over the past few years, this therapy has quickly gained popularity and widespread use in China.
Recently, the China National Medical Products Administration (NMPA) implemented significant regulatory changes that largely affect the manufacturing and sale of RLRL devices. This marked a pivotal shift for the future of myopia treatment using RLRL in China.
For over three decades, practitioners in China have used RLRL therapy as an alternative treatment for amblyopia, despite lacking conclusive evidence regarding its efficacy. In recent years, researchers and clinicians have repurposed RLRL as a new method for treating myopia, leading to its increased use among the population. This trend is partly based on several randomized clinical trials (RCTs) conducted in China, which suggest that RLRL can effectively slow the progression of myopia, reduce axial elongation, and enhance choroidal thickness with follow-ups lasting up to 12 months. Furthermore, one study indicates that RLRL may decrease the incidence of myopia.
RLRL has quickly garnered significant attention from the ophthalmic industry, parents, and researchers in China. While it is challenging to determine the exact number of children who have received RLRL therapy, data from the NMPA website suggests that around 20 companies have obtained medical licenses for RLRL devices between 2021 and 2023.
Meanwhile, regulatory authorities in several countries, such as Australia, have approved RLRL devices for myopia as medical devices. Notably, researchers conducted all published clinical trials on these devices in China.
The regulatory landscape for RLRL devices in China has recently evolved significantly. Initially, the NMPA classified RLRL devices as class II, following earlier regulations specific to amblyopia treatment. Similar to the system used by the US Food and Drug Administration, class I, II, and III devices in China correspond to low-, intermediate-, and high-risk levels, respectively. Regulatory authorities require additional controls for Class II devices to ensure their safety and effectiveness; however, they do not strictly mandate clinical trials.
In mid-2023, the NMPA reclassified RLRL devices as class III, imposing more stringent regulatory oversight. Rigorous safety and effectiveness research is now necessary before approval, and the approval process is solely managed by the national NMPA, rather than provincial administrative departments. As of July 1, 2024, RLRL devices without a class III registration certificate cannot be manufactured or sold in China, and all previously approved RLRL products under class II certification will have their approvals revoked and invalidated.
Following this reclassification, the NMPA released a detailed guideline outlining the criteria for class III registration of RLRL devices. This guideline requires that manufacturers conduct extensive safety studies, including trials on primates and long-term histopathological assessments, which must be completed and reviewed before initiating any clinical trials.
The evolving regulatory framework for RLRL therapy in China underscores the critical balance between advancing medical innovation and ensuring patient safety. This balance is particularly important given the significant public health implications and the large market associated with juvenile-onset myopia. As technology advances, new treatments emerge rapidly, making this balance even more essential than ever.
Abstract
Red Light Therapy for Myopia — Current Regulatory Changes in China
Ya Xing Wang, MD, PhD; Ningli Wang, MD, PhD; Tien Yin Wong, MD, PhD
This Viewpoint discusses the ophthalmic device, red light therapy, for myopia treatment in children and adolescents in China, including its development and use, safety concerns, and implications surrounding recent regulatory changes and reclassification of this device.
Wang, Y. X., Wang, N., & Wong, T. Y. Red Light Therapy for Myopia—Current Regulatory Changes in China. JAMA ophthalmology. 2025 Jan 23. E-pub ahead of print
DOI: 10.1001/jamaophthalmol.2024.5977
