Another Beijing E-Town Manufacturer enters green channel for innovative medical device approval
Beijing Charmwin Optoelectronic Medical in Beijing E-Town recently obtained approval from the Beijing Municipal Drug Administration (NMPA) for its innovative medical device - the "LED Red Light Therapy Device".
In 2014, the NMPA launched a special approval and review procedure for innovative medical devices, prioritizing the evaluation and approval of medical devices with patented technologies, domestic pioneering status, international leadership, and significant clinical application value. It is known in the industry as the “green channel”.
Charmwin's LED Red Light Therapy Device belongs to the intersection of medicine and lighting. It has innovatively developed LED red light into a high-power density, large-area, naturally dissipating, flexible and wearable phototherapy device.
Charmwin possesses the core technology of Charmwin Light's light source module. Its core light source has been adopted by top European photobiology research institutions and received high praise.
"The project has completed equipment type inspection and clinical trials, and plans to apply for Class II medical device registration in July," introduced the head of the enterprise.
At present, Charmwin Light has completed the development of multiple products, including the treatment of dysmenorrhea, stretch marks, non-specific lower back pain, neonatal jaundice, and rheumatoid arthritis, and has initiated new projects such as the treatment of gynecological inflammation using light therapy.