• Journal of Korean Ophthalmic Optics Society
• /
• v.12 no.3
• /
• pp.143-149
• /
• 2007

We have compared and analyzed the definition of medical devices, classification, who treats, controls and sales the spectacle frames in South Korea, USA and European Union in this paper. South Korea classifies the spectacle frames as an industrial products while EU and USA regards it them as the medical devices. Sunglasses are industrial products in South Korea and EU but they are still the medical devices in USA. Assignment of spectacle frames and sunglasses as an industrial products could bring into several problems. Restricted classification of medical devices on spectacle frames and sunglasses will resolve the problem mentioned.