Through Japan-US Medical Device Harmonization by Doing (HBD)1, the U.S. FDA2, MHLW/PMDA, academia, and industry developed internationally agreed upon standards for global clinical trials related to cardiovascular devices, and addressed regulatory barriers that may delay timely medical device approvals in both countries.
In order to announce the outcome of recent HBD activities and discuss future plans with the public, the HBD East 2023 Think Tank Meeting will be held on December 14, 2023 in Tokyo.
Ref:
1) HBD Brochure (in English)
2) U.S.-Japan Regulatory Collaboration | FDA
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
The Japan Federation of Medical Device Associations (JFMDA)
For more information on HBD East 2023 Think Tank Meeting, please click here.
Thursday, December 14, 2023
9:30 a.m. - 6:00 p.m.
Ariake Central Tower and Conference (Tokyo)
Registration fee : Free
Registration system (Deadline : 21th,November(JST) ) :
https://reg18.smp.ne.jp/regist/is?SMPFORM=linj-ljmhtb-c5b5780fc27168581cfda88de47763cb