About HANDA ENTERPRISE
HANDA ENTERPRISE provides strategic consulting for medical device, IVD, and SaMD development in Japan, combining clinical experience, regulatory expertise, hands-on product development, and evidence generation. We support companies, startups, and research institutions in navigating the Japanese regulatory pathway from development strategy and PMDA consultation preparation to clinical evidence generation and market entry.

Nobuhiro Handa, MD, PhD
Founder & Principal Consultant
Physician and medical device regulatory expert with extensive experience in clinical practice, regulatory review, medical device and IVD development, clinical evidence generation, and large-scale healthcare data analysis.
Eight years of experience as a physician reviewer at PMDA, including medical device review and involvement in international regulatory harmonization through the IMDRF.
His clinical background spans cardiovascular medicine and geriatrics & gerontology. He also has extensive experience in large-scale healthcare database research and real-world data analysis, providing an integrated perspective that bridges patient care, product development, evidence generation, and regulatory strategy.
Selected Publications
Medical Device Innovation and Regulatory Expertise
1. Handa N, et al. Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan.
EBioMedicine. 2015;2(9):1211-6. doi: 10.1016/j.ebiom.2015.07.011.
2. Yokoi H, et al. Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese
Perspective. Circ J. 2018;82(9):2233-2239. doi: 10.1253/circj.CJ-18-0014.
3. Handa N, et al. Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment:
PMDA's perspective. J Artif Organs. 2020;23(3):203-206. doi: 10.1007/s10047-020-01161-4.
Real-World Data & Evidence Generation
4. Handa N, et al. Associations of coprescribed medications for chronic comorbid conditions in very old adults with clinical dementia: a
retrospective cohort study using insurance claims data. BMJ Open. 2021;11(7):e043768. doi: 10.1136/bmjopen-2020-043768.
5. Handa N, et al. Safety profile of hypnotics or sedatives on community-dwelling older adults aged 75 or older in Japan: A retrospective
propensity-matched cohort study. Int J Geriatr Psychiatry. 2024;39(4):e6085. doi: 10.1002/gps.6085.
Clinical Registry & Risk Stratification
6. Handa N, et al. Procedure- and age-specific risk stratification of single aortic valve replacement in elderly patients based on Japan Adult
Cardiovascular Surgery Database. Circ J. 2012;76(2):356–364. doi: 10.1253/circj.cj-11-0979.