NMPA: Myopia Control and Amblyopia Treatment Containing Light Sources

I. Purpose  

To standardize the determination of the regulatory attributes and management categories of medical devices for myopia control and amblyopia treatment containing light sources, these guiding principles are formulated in accordance with the "Regulations for the Supervision and Administration of Medical Devices," the "Medical Device Classification Rules," the "Medical Device Classification Catalog," and other relevant regulations.  

II. Scope  

The medical devices for myopia control and amblyopia treatment containing light sources referred to in these guiding principles are products that meet the definition of medical devices under the "Regulations for the Supervision and Administration of Medical Devices," contain light sources, and are intended for myopia control or amblyopia treatment by irradiating the eyes with light (including products achieving the aforementioned purposes through training).  

These guiding principles do not apply to optometry equipment and devices, visual function examination equipment and devices, ophthalmic measurement and diagnostic equipment and devices, ophthalmic laser surgical treatment equipment, intraocular illumination equipment and devices, low vision aids, contact lenses, independent software products for myopia control (including training), and independent software products for amblyopia treatment (including training).  

III. Determination of Regulatory Attributes  

The regulatory attributes of medical devices for myopia control and amblyopia treatment containing light sources shall be comprehensively determined based on the product's intended use, mechanism of action, and other factors.  

For other products containing light sources that achieve their intended purpose by irradiating the eyes with light, if the product does not meet the definition of a medical device under the "Regulations for the Supervision and Administration of Medical Devices," it shall not be managed as a medical device. The intended use claimed for such products shall explicitly state "not for myopia prevention and control (including training) or amblyopia treatment (including training)." For example:  

- Products containing non-laser light sources that irradiate the eyes to alleviate visual fatigue caused by excessive eye use in the general population and are not intended for myopia prevention and control (including training) or amblyopia treatment (including training).  

- Eye massagers where the contained light source only provides a warm massage effect on the periorbital skin and are not intended for myopia prevention and control (including training) or amblyopia treatment (including training).  

- Eye-protection desk lamps where the light emitted by the contained light source provides a comfortable lighting environment and are not intended for myopia prevention and control (including training) or amblyopia treatment (including training).  

IV. Determination of Medical Device Management Category  

The management category of medical devices for myopia control and amblyopia treatment containing light sources shall be comprehensively determined based on the characteristics of the light source, structural features, intended use, form of use, and other factors.  

1  If the product uses laser light sources to irradiate the eyes for myopia control or amblyopia treatment, it shall be managed as a Class III medical device, with classification code 16-05.  

2  If the product uses red light generated by non-laser light sources (e.g., LED light sources) to irradiate the eyes for myopia control, it shall be managed as a Class II medical device, with classification code 16-03.  

3  If the product uses non-laser light sources (e.g., LED light sources, monochromatic light sources formed by halogen or tungsten lamps with filters) to irradiate the eyes for amblyopia treatment, it shall be managed as a Class II medical device, with classification code 16-03.  

Note: Products using light irradiation of the eyes for myopia control or amblyopia treatment should fully consider factors such as potential cumulative damage to the patient's retina during clinical use and should be used with caution.  

V. Other Provisions  

Medical devices for myopia control and amblyopia treatment containing light sources shall not be assigned classification code 09 (Physical Therapy Devices) under the "Medical Device Classification Catalog," nor shall they be assigned classification code 19 (Medical Rehabilitation Devices).