MDREX Newsletter

2024.5.22.

MDREX, Online seminar on the procedures and case studies for insurance reimbursement of medical devices (SaMD, etc.) in Japan

As innovative medical devices incorporating AI technology (e.g., SaMD and DTx) continue to be developed diversely within the domestic market, MDREX plans to host an online seminar in collaboration with the Medical Device Industry Association on "Insurance Registration of Medical Devices in Japan." It's worth noting that the size of the Japanese medical device market ranks among the top 3-4 globally (approximately four times the size of the Korean market), making it a country that domestic medical device companies considering overseas expansion must consider, following Europe and the United States. However, due to stringent market entry regulations and complex insurance reimbursement procedures, many excellent medical devices from Korea have been unable to enter Japan, or if they do, they often receive lower prices. Therefore, MDREX plans to introduce the specific procedures and cases of insurance reimbursement of medical devices in Japan to member companies of the Medical Device Industry Association.

• Seminar objective: Introduction to Insurance Reimbursement Procedures and Cases of Japanese Medical Devices (SaMD, etc.)
• Seminar schedule : May 29, 2024 (Wed, 15:00~16:00)
• Seminar pre-application: https://forms.gle/j1wmq7guqFpAAMpi8
• Seminar pre-application period : May 24, 2024
• Seminar online link: the Medical Device Industry Association will provide a link to the pre-application participants mentioned above.
• Seminar fee: N/A

The main content of the seminar will focus on "Japan's insurance reimbursement administrative procedures, classification criteria for new functions/technologies (C1/C2), additional fees based on facility standards, and challenge system." Additionally, considering the characteristics of domestic medical device companies, we plan to introduce "cases of registration for similar products (e.g., various products incorporating AI technology, prognostic and DTx devices).

The presenters will consist of three individuals, and the seminar will be conducted in Korean. In cases where immediate answers are not possible during the Q&A session, we will collaborate with MDREX's Japanese partner to provide specific answers in the foreseeable future. We encourage MDREX clients interested in Japanese regulations to attend.

Please note that the seminar content will be recorded and can be viewed on YouTube

at (https://www.youtube.com/@RA_QA_MA).

Thank you.