Medical Device & IVD Development and Regulatory Consulting in Japan
Supporting medical device and IVD companies, startups, and research institutions with Japanese regulatory strategy, PMDA consultation preparation, clinical evidence generation, and market entry.
Our Services
Strategic support for medical devices, IVDs, and SaMD throughout the development and regulatory pathway in Japan.
Japan Regulatory Strategy
Strategic guidance on regulatory pathways, product classification, development planning, and submission strategy for medical devices, IVDs, and SaMD in Japan.
PMDA Consultation Support
Strategic support for PMDA consultations, including consultation strategy, preparation of briefing materials, and regulatory communication.
Clinical Evidence Strategy & Generation
Strategic planning and generation of clinical evidence to support regulatory submissions, product development, and clinical positioning.
Japan Market Entry Support
Strategic support for overseas medical device and IVD companies navigating regulatory requirements and entering the Japanese market.
Clinical Experience
Clinical perspectives grounded in extensive experience in patient care, cardiovascular medicine, geriatrics, and gerontology.
Regulatory Experience
Eight years of experience as a physician reviewer at PMDA, including medical device review and involvement in international regulatory harmonization through the IMDRF.
Medical Device & IVD Development
Hands-on experience in medical device and IVD development, bridging clinical needs, product development, clinical evidence, and regulatory submission.
Data & Evidence Generation
Expertise in clinical research, real-world data analysis, and evidence generation to support product development and regulatory strategy.
Our Expertise
Why HANDA ENTERPRISE