About MK Consulting

Representative Director

Kohei Kakuno

At Century Medical, Inc., he was responsible for introducing endoscopic therapeutic devices from overseas medical device manufacturers, including Taewoong Medical Co., Ltd., MICRO-TECH (Nanjing) Co., Ltd., and Ovesco Endoscopy AG, to the Japanese market and launching the related businesses.

Later, at Boston Scientific Japan K.K., he was involved in introducing SILUX biliary plastic stents to the Japanese market and supporting the development of other Japan-based OEM products.

In 2018, he launched UMIDAS and supported the development of ERCP-related medical devices, including the biliary plastic stent “UMIDAS NB Stent” and the “ERCP Guide Sheath.” These products remain part of Olympus's medical device product lineup in Japan.

Drawing on his experience in introducing overseas products to Japan, launching businesses, and developing Japan-based OEM and ERCP-related devices, he currently supports regulatory strategy, consultations with PMDA and Registered Certification Bodies, approval and certification applications, clinical evaluation, QMS, reimbursement, and Japan market entry at MK Consulting K.K.

Director

Masaaki Hitomi

At Century Medical, Inc., he worked on numerous approval applications, including Class III and IV medical devices, and was responsible for obtaining approvals for multiple products, including cases that used clinical trial data generated overseas. He also handled health insurance coverage under Japan's C categories for multiple products.

For products where PMDA consultation indicated that a new clinical study would be required, he also evaluated and implemented an approval application approach using clinical evaluation reports based on the review and assessment of existing literature, resulting in approvals for multiple products.

Later, he participated in the launch of CONMED Japan and was responsible for establishing QMS and GVP systems and related procedures for obtaining a Type I medical device Marketing Authorization Holder license, supporting the process through license acquisition.

Based on this experience, he currently supports medical device approval applications, PMDA consultations, clinical evaluation, QMS/GVP, reimbursement, and Marketing Authorization Holder licensing at MK Consulting K.K.