NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline offers regulatory clarity for market entry of ophthalmic devices that use light to manage myopia or treat amblyopia. For international manufacturers, this marks a key opportunity to align with Chinese regulations and meet rising demand for pediatric vision correction solutions.
Scope of the Guideline
The guideline applies to medical devices that:
- Contain a light source (such as lasers or LEDs),
- Use light to irradiate the eyes,
- Are intended for myopia control or amblyopia treatment, including devices that achieve these outcomes through training-based mechanisms.
This scope also includes products labeled as “myopia training devices” or “amblyopia rehabilitation trainers” that ultimately aim for clinical improvement of myopia or amblyopia. These are considered medical devices regardless of whether the therapeutic mechanism involves physical therapy, behavioral training, or light exposure.
However, the guideline excludes the following:
- Devices without a light source,
- Equipment utilizing electric, magnetic, or thermal mechanisms,
- Diagnostic tools like optometric and ophthalmic measuring instruments,
- Ophthalmic surgical laser devices,
- Non-therapeutic eye massagers or ambient light lamps not aimed at vision correction,
- Standalone software products for vision training or monitoring.
Determining Product as Medical Device
To qualify as a medical device under China’s Regulations on the Supervision and Administration of Medical Devices, a product’s intended purpose and mechanism of action must align with therapeutic or diagnostic use.
The document explicitly excludes:
- Light-based products aimed only at relieving eye fatigue in healthy individuals (e.g., LED lamps for general wellness),
- Eye massagers where light is used solely for heating eye-surrounding skin,
- Eye protection lamps that provide comfortable lighting but are not involved in myopia control or amblyopia treatment.
For these, manufacturers must clearly state in product documentation that the devices are not intended for myopia control or amblyopia treatment, to avoid misleading marketing or unintentional classification as medical devices.
Risk-Based Classification and Coding
The guideline establishes clear risk-based classifications for light-based devices:
- Class III (High Risk): Devices that use laser light sources to irradiate the eye for myopia control or amblyopia treatment fall into this category. They are assigned Classification Code 16-05 due to higher safety concerns.
- Class II (Moderate Risk): If the product uses red light from a non-laser light source (such as an LED light source) to irradiate the eyes for myopia control, it shall be regulated as a Class II medical device, with Classification Code 16-03.
Currently, red LED light is the only color with some safety and efficacy evidence for myopia control. Products using other colors or alternative mechanisms will require further scientific validation and case-by-case classification through formal application.
It’s important to note that products falling under this guidance must be classified under Category 16 – Ophthalmic Devices. They cannot be listed under:
- Category 09 – Physical Therapy Devices, or
- Category 19 – Medical Rehabilitation Devices (used for visual stimulation but without light sources).
Standardized Naming
To avoid ambiguity, the guideline advises that such products be named:
- “Myopia Control Devices” (instead of “Myopia Treatment” or “Myopia Prevention” devices), reflecting current clinical understanding that myopia cannot be cured or prevented, but its progression can be delayed.
- “Amblyopia Treatment Devices”, as existing clinical methods for amblyopia have demonstrated curative outcomes.
This nomenclature reflects scientific accuracy and regulatory precision, ensuring that product names do not overpromise outcomes beyond what current technology supports.
Future Regulatory Pathways for Non-Light-Based Devices
While the current guideline is focused solely on light-based devices, non-light-based devices for vision correction are still subject to regulation under the Medical Device Classification Catalogue. For products using alternative methods—such as mechanical lens shifting to exercise the ciliary muscle—manufacturers must refer to other regulatory documents or apply for product-specific classification determinations.
Implications for Overseas Manufacturers
This regulatory update reflects China’s increasing attention to the booming vision care market, especially among children and adolescents affected by the country’s high myopia prevalence. For international companies, it is vital to:
- Adapt existing products to comply with Chinese classification codes and risk levels;
- Demonstrate clinical validity and safety in light-based vision therapy devices,
- Avoid mislabeling or over-claiming functions that may reclassify the device as a higher-risk product.