July 2018: Japan Regulatory Updates

The U.S. and Japan are also committed partners in the International Medical Device Regulators Forum, which is a group that works together to accelerate international medical device regulatory harmonization and convergence.

HBD organizes scientific sessions in conjunction with annual scientific conferences to promote regulatory convergence between FDA and MHLW premarket reviews and discuss advances in cardiovascular technology. In 2013, the Transcatheter Cardiovascular Therapeutics (TCT) Conference included a special session on HBD, 10th Anniversary Harmonization by Doing (HBD) at TCT: Novel Japan-US Synergy Research Opportunities in Global Medical Device Innovationdisclaimer icon.

The Harmonization by Doing East (HBD) 2017 Think Tank Meeting disclaimer icon will be held on December 7, 2017 at the National Center for Global Health and Medicine in Tokyo. In addition to Working Group activity updates, this meeting will discuss recent hot topics such as Early Feasibility Studies and Real-World Evidence. This meeting will be open to public, and will also include a round table discussion where HBD members and other experts can share their experiences and have a free discussion on overcoming challenges in medical device clinical trials.

Leave a Reply