Tsuyoshi Kato

Tsuyoshi Kato has more than 30 years of experience in roles related to Japan's Pharmaceutical Affairs Law, including clinical operations, quality management and regulatory applications. He has spent most of his career in the cardiovascular field, specializing in coronary artery therapies and rhythm management. Prior to joining MCRA Japan, Tsuyoshi worked at Boston Scientific, managing a wide array of regulatory projects including multiple drug eluting stent products, bare metal stents, IVUS catheter and console and other IC/PI devices. 

As a member of MCRA Japan’s Regulatory Affairs team, Tsuyoshi manages regulatory consultations and submissions for cardio and cerebrovascular programs as well as orthopedic devices. Tsuyoshi has led the Shonin approvals of multiple of Class III and Class IV products, helping companies navigate the initial PMDA consultation process through post-approval activities. Tsuyoshi is a seasoned regulatory expert with a deep understanding of clinical operations and quality systems. He specializes in regulatory strategy and regulatory submission development as well as evaluation of pre-clinical and clinical data.