The Medical device offices of PMDA recognizes the importance of globally harmonized medical device regulatory policy and practices. This page explains how the PMDA collaborates with stakeholders in U.S. and Japan through the Harmonization by Doing (HBD) initiative, and provides information on programs, resources, and accomplishments.
Through HBD-led projects, U.S. and Japanese regulators (including the FDA), academia, and industry collaborate regularly to promote regulatory convergence and address barriers that may delay patients in both countries from getting timely access to safe and effective medical devices.
Scientific Sessions and Think Tanks
HBD organizes scientific sessions in conjunction with annual clinical and regulatory conferences in the U.S. and Japan, such as those listed below:
- Cardiovascular Revascularization Therapies (CRT)
- Japan Endovascular Treatment (JET)
- Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT)
- Pediatric Interventional Cardiovascular Society (PICS)
- Regulatory Affairs Professionals Society (RAPS)
- Transcatheter Cardiovascular Therapeutics (TCT)
- Vascular InterVentional Advances (VIVA)
HBD also organizes stand-alone “Think Tanks” to discuss emerging issues in medical device development and access, such as pediatric device development, use of real-world clinical evidence, and regulation of digital health technologies.