JSK Biomed's Mirajet Achieves World-First CE Certification

On the last 12th, JSK Biomed has revealed that its needle-free injection system “Mirajet” acquired the world’s first “CE-MDD (CE mark certification for medical devices)” from the EU.

According to JSK Biomed, “Mirajet” allows penetration of medicine through the skin without needles using the powerful energy of laser pulse instantly. This is the world's first application using a laser pulse pressure technology other than the existing air pressure method. In particular, it is more suitable for an aesthetic treatment that requires a rapid injection of a small amount of medication into a wide area.

The original technology was transferred to JSK Biomed from Seoul National University and began commercialization since November 2015. It was approved by the Ministry of Food and Drug Safety in January this year and accomplished splendid achievement in marketing the product to a front line of dermatological clinics first in the world in April.

Since the second half of 2019, JSK Biomed has processed a certificate through Italy-based MTIC. MTIC is an international certification body that certifies a wide range of systems, products, and personnel that meet the requirements of international standards, European directive (CE markings), and national regulations. After examinations by MTIC, JSK Biomed received a copy of the final version of CE marking on the 11th of this month.

CE-MDD is a regulation on quality, performance, durability, and safety proposed by the EU. This is issued to only products that pass strict requirements and evaluation criteria under the conformity procedure. The certification is necessary for exporting and selling products to Europe. As Mirajet has acquired the CE marking, it can reach into 27 countries of EU and regions that acknowledge EU CE marking such as the Middle East, Asia, and Central and South America. Mirajet is currently preparing for FDA approval from the United States.

“Mirajet commercialized an innovative technology of injecting medicines with fast speed into the skin without needles,” Chang-Hun Huh, the professor of the dermatologic department at the Seoul National University Bundang Hospital said. “It is easy and convenient to inject drugs, so patients can undergo various procedures without fear or pain from needles. We will continue to create new markets not only in the beauty field but also in the skin area such as hair loss or cancer treatment,” he added.

“Painless drug injection system will lead the ‘drug delivery system (DDS)’ in medical aesthetic areas such as wrinkles, hair loss, obesity, etc.,” JSK Biomed CEO Jun Jin Woo stated. “Beginning with the medical aesthetic field, we will lead a worldwide needle-free injection market by broadening its applications to general drug administration,” he added.

Meanwhile, JSK Biomed is a medical device startup that is committed to expanding markets by introducing South Korea’s medical technologies and products to the world.