On January 21st, the National Medical Products Administration solicited public opinions on the “Guiding Principles for Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment (Draft for Comments)”. It is mentioned that the management category of medical devices for myopia control and amblyopia treatment should be comprehensively determined based on their light source characteristics, structural features, expected use, and form of use. If the product uses laser as a light source to irradiate the eyes for myopia control or amblyopia treatment, it shall be classified and coded as 16-05 according to the management of Class III medical devices. If the product uses red light generated by LED as a light source to illuminate the eyes for myopia control, it is classified and coded as 16-03 according to the management of Class II medical devices. If the product uses the light generated by LED as the light source to irradiate the eyes, or uses the monochromatic light formed by halogen lamps or tungsten filament lamps through filters as the light source to irradiate the eyes for amblyopia treatment, it shall be classified and coded as 16-03 according to the management of Class II medical devices.
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