China has recently reclassified repeated low level red light (RLRL) devices for use in myopia treatment from Class II to Class III,1 as reported by Wang et al, in a viewpoint article published in JAMA Ophthalmology.
Similar to the system employed by the United States Food and Drug Administration, the China National Medical Products Administration (NMPA) classifies devices into class I, II, and III, which correspond to low-,intermediate-, and high-risk levels, respectively.
However, unlike other international countries, class II devices in China are managed on a provincial administrative level without standardised requirements including for clinical trials. The recent reclassification to class III therefore results in more rigorous regulatory oversight on a national level, exclusively managed by the national regulatory body as in other jurisdictions. This renders previous Class II registrations invalid in China from 1 July 2024, meaning RLRL devices manufactured after 1 July 2024 can no longer be sold until they undergo a reclassification process, which could take years.
No Impact Outside China
Eyerising International, the manufacturer of the Eyerising device in all jurisdictions excluding China, has offered a response to this article. Although the company is a separate company from Suzhou Xuanjia Optoelectronics Technology (SXOT) which manufactures and sells the Eyerising device in China, the statement addresses concerns from the international community regarding this reclassification, particularly as the Eyerising device is the only RLRL device to have yet achieved international regulatory approval.
Eyerising International said “As a novel therapy for myopia management, Eyerising International welcomes the need for appropriate regulatory oversight into RLRL in China.
“Whereas most countries and the European Union regulate medical devices on a national or regional level, a Class II classification in China means regulatory approvals are mandated on a provincial administrative level with no standardisation of requirements from both an efficacy and safety perspective.
“This resulted in over 20 RLRL devices being approved with varying degrees of clinical evidence, some of these without any published clinical studies proving their effect.
“In contrast, the Eyerising device in China is backed by a robust body of clinical trials and evidence, making it one of the most thoroughly supported devices in this category”.
International Approval
Unlike other RLRL devices in China, the Eyerising device has received Class IIa/Class B regulatory approval internationally, “based on strong evidence of its efficacy and safety”. Eyerising International stated that these approvals were granted independently and are not dependent on China’s NMPA.
“Therefore, the recent reclassification in China to Class III does not affect the Eyerising device. Going forward, the Eyerising device’s supporting evidence will be submitted for national NMPA review in China by Suzhou Xuanjia Optoelectronics Technology, as Eyerising International has done in other markets.”
Continued use in China
Eyerising International also confirmed that the reclassification does not constitute a product recall within China for SXOT.
“Existing users of RLRL devices in China are allowed to continue using the device, and all devices manufactured before 1 July 2024 are allowed to be sold. As a result, the Eyerising device remains in use by over 110,000 daily users in China. Despite rigorous monitoring for complications by the NMPA, no significant adverse events have been observed. The single case report of reversible changes mentioned in this article was also submitted as part of both Suzhou Xuanjia Optoelectronics Technology’s and Eyerising International’s ongoing post-market surveillance.”
Need for Continued Research and Monitoring
Ophthalmologist Associate Professor Loren Rose, who is currently using the Eyerising RLRL device to treat patients with myopia resistant to other treatments, also welcomed the reclassification in China, and agreed that stringent monitoring is essential.
She said the one published adverse RLRL event had “concerned everyone” back in 2023 and highlighted the need for close supervision and a clear treatment protocol.
“The children (being treated with RLRL) need close monitoring, and OCT should be mandatory. I have a couple of patients doing well, but I have watched them closely, especially at the start.”
She acknowledged that in China, many “copycat devices may not be well-built to regulate the light dose”, noting as well the “lack of appropriate animal studies, and this is highlighted with China asking for this data now as part of their approval”, which she would support. She also advocated for additional research into the treatment dose required for greatest efficacy. “Does treatment need to be over five consecutive days; could the currently recommended three-minute treatment be shortened or treatment frequency reduced to get the same effect?”
Evolving use of RLRL
In agreement with the ViewPoint article and Assoc Prof Rose, Eyerising International acknowledged the need for “a crucial balance between advancing medical innovation and ensuring patient safety”. For this company, the way forward involves both stringent safety monitoring of current use of RLRL, and continued research into RLRL’s mechanism and optimisation, which they reassure are currently underway. Such research would be instrumental in the developing field of RLRL, although the manufacturer argues this need not necessarily delay current use of RLRL as long as it is deployed in an appropriately monitored manner.
Highlighting Eyerising International’s “safety precautions and stringent monitoring”, the manufacturer stated that “the Eyerising device is only available through an eye care professional (e.g. optometrist, ophthalmologist) that has been appropriately trained on RLRL, and has never been made available without physician oversight.
“We also require regular follow-up of all patients using the Eyerising device at one, three and six months and every six months thereafter, and strongly recommend OCT (optical coherence tomography) at each of these appointments, to be reassured of continued safety.”
Concluding its response, Eyerising International stated it “support the efforts in China to standardise and improve their regulatory oversight into RLRL. However, we would like to clarify that the reclassification in China does not reflect current safety or regulatory concerns on the part of the Eyerising device or Eyerising International.
“We remain committed to the continued efficacy and safety of our product, and continued safety monitoring practices and ongoing research as RLRL adoption increases in future.”
Reference
- Wang YX, Wang N, Wong TY. Red Light Therapy for Myopia-Current Regulatory Changes in China. JAMA Ophthalmol. 2025 Jan 23. doi: 10.1001/jamaophthalmol.2024.5977. Epub ahead of print. PMID: 39847347.
