Yuya Kumagai

Yuya Kumagai

Regulatory Affairs Associate

Yuya Kumagai, with over five years of experience in MedTech regulatory affairs in Japan, has previously managed PMDA submissions as well as US 510(k) clearance, Taiwan, and ASEAN registrations for devices used for physical rehabilitation. At Vorpal, Yuya's responsibilities include PMDA consultations, drafting marketing approval documentation, product evaluation, and reimbursement support, with notable contributions across various Class IV product types including  orthopedics and cosmetics and new Class II SaMD products.