KTC Signs MOU with COSMOS to Support Domestic Medical Device Companies' Expansion into Japan
▲ Photo of the KTC-COSMOS MOU signing ceremony (Left: Kay Hamaguchi, CEO of COSMOS, Right: Sungil Ahn, President of KTC)
Korea Testing Certification institute (KTC) announced on August 4th that it has signed a MOU with COSMOS, a Japanese certification body, to support the export of domestic medical device companies to Japan.
COSMOS is a certified testing and certification organization in the field of medical devices and is registered as an International Electrotechnical Commission (IEC) National Certification Body (NCB) for medical devices in Japan. It is a third-party certification body designated by the Ministry of Health, Labour and Welfare of Japan, responsible for overseeing medical device regulations.
Under the MOU, KTC will collaborate with COSMOS, Japan's largest medical device certification body, to △ facilitate medical device certification △ exchange information on standards and technical documents △ expand technical exchanges through seminars and more. Particularly, KTC will provide technical feedback and review on the evaluation of Summary Technical Documents (STED), an essential component of international standardization technology documents that many companies often find challenging during the process of obtaining medical device certification in Japan. This support is expected to significantly enhance operational convenience for our companies in the future.
Japan's medical device market ranks third globally, following the United States and Germany, with an average annual growth rate of 4.5%. The market has consistently expanded in size. In 2022, our companies' exports of medical devices to Japan amounted to approximately $630 million, showing a substantial increase of 127% compared to the previous year. As the aging population accelerates, leading to increased healthcare expenditures, the Japanese medical device market is anticipated to grow even more rapidly.
To further facilitate the expansion of our companies into Japan, KTC not only plans to provide support through testing and certification but also intends to organize education and seminars targeting businesses within the third quarter of this year. KTC will offer the latest certification information and acquisition strategies for entering the demanding Japanese market, characterized by stringent approval procedures.
President Sungil Ahn of KTC stated, "The medical device industry is a future growth sector and a nationally important industry with continuous growth prospects," and he expressed, "Through systematic certification support, we will drive the expansion of the medical device industry into Japan."
This collaboration between COSMOS and KTC follows an ongoing partnership that began with KTC's visit to COSMOS in March this year. With this MOU, KTC has expanded the scope of its collaborative efforts from fields such as electric vehicle chargers and wires/cables, which previously included PSE (mandatory certification in Japan), to the medical device sector, enabling comprehensive support for our companies' expansion into Japan.
