July 31, 2025
National Medical Products Administration Sets "Red Lines" for LED Light Safety; Industry Enters a New Era of Standardization
On July 11, 2025, the National Medical Products Administration officially issued the “Guidance Principles for the Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment Containing Light Sources” (hereinafter referred to as the “Guidance Principles”), clearly defining the “red lines” for the regulation of medical-grade light sources, with the document taking effect immediately. This move is viewed by the industry as a major turning point for the development of the light health industry.
On July 11, 2025, the National Medical Products Administration officially issued the “Guidance Principles for the Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment Containing Light Sources” (hereinafter referred to as the “Guidance Principles”), clearly defining the “red lines” for the regulation of medical-grade light sources, with the guidelines taking effect immediately.This move is viewed by the industry as a major turning point for the development of the light health industry.
Key Points of the New Regulations at a Glance
Clarification of Regulatory Status: Products containing light sources and used for myopia control or amblyopia treatment are classified as medical devices.
Detailed Classification Criteria:
Laser light sources → Class III medical devices (16-05);
LED red light sources used for myopia control → Class II medical devices (16-03);
LED/halogen light sources used for amblyopia treatment → Class II medical devices (16-03).
Define promotional boundaries: Non-medical products must be labeled with the statement “Not intended for myopia control or amblyopia treatment,” and exaggerated claims regarding therapeutic effects are prohibited.
Emphasis on Safety: The risk of cumulative retinal damage during clinical use must be assessed to ensure patient safety.
Background: Urgent Need to Address Industry Chaos
In recent years, with the widespread use of electronic devices, eye health issues have become increasingly prominent, and LED health lighting technology has rapidly emerged. However, industry irregularities have become frequent:
Exaggerated Claims: Some non-medical products misuse medical terminology such as “treatment” and “correction”;
Non-compliant use of light: The use of violet light and far-infrared light wavelengths beyond approved ranges poses potential safety risks.
The release of these “Guidelines” will regulate industry development at its source, prevent the “overgeneralization of concepts,”and ensure that light-based health products truly return to their scientific foundations.
Industry Implications: Standardization and High Quality Go Hand in Hand
These new regulations not only provide medical institutions with clear criteria for product evaluation, ensuring the safety and effectiveness of myopia and amblyopia treatments, but also, by strictly controlling the promotional boundaries of non-medical products, promote the “separation of fact from fiction” in the LED health lighting industry, propelling it toward precise, scientific, and high-quality development.
MiJi Technology will actively comply with the policy, leveraging innovations in AI and optical technology to create smarter, healthier, and safer lighting environment solutions, thereby helping the industry enter a new era of standardized development.
What do you think: Is the LED health lighting industry experiencing “tightened regulation” or “accelerated standardization”?
Annex to Announcement No. 25 of 2025 by the National Medical Products Administration.docx