The Ministry of Food and Drug Safety said that it has set up a new guideline for a smart contact lens that can measure blood sugar.
The ministry expects that the new guideline will help realize the commercialization of smart contact lens as medical devices.
A smart contact lens is used to manage diabetes patients by embedding a sensor into a contact lens to measure the glucose level in a patient’s tears and converting it into blood glucose levels. Afterward, the data is sent to the user's smartphone or other IT devices.
“In the era of the Fourth Industrial Revolution marked by the rapid development of science and technology, products in movies and science fiction are becoming a reality,” the ministry said. “The government is trying to improve relevant systems and guidelines.”
Local companies are also working hard to break the stereotype that contact lenses should be used only for vision correction and develop them into smart devices that combine medicine, medical equipment, and information and communication technology, the ministry noted.
The guidelines contain requirements for ensuring the electromechanical and biological safety of smart contact lenses and their efficacy in verifying glucose levels while performing its conventional roles as a contact lens.
“This guideline is significant as a preemptively establish guidelines for products being developed through public and private cooperation,” the ministry said.
In response to the changing times, the government will actively support the rapid commercialization of medicines, medical device convergence products, and innovative and creative medical devices to strengthen the competitiveness of the local medical device industry and improve the quality of public health, the ministry added.