Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA.
U.S. Food and Drug Administration, Silver Spring, MD, USA; U.S. & Japan Medical Device Harmonization by Doing (HBD) Group, USA.
Cardiovasc Revasc Med. 2022 Apr;37:118-119. doi: 10.1016/j.carrev.2021.08.020. Epub 2021 Sep 1.
Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.
日本和美利坚合众国（美国）的医疗器械监管审批流程通常需要类似的临床试验来建立安全性和有效性。通过做来协调（HBD）计划为监管机构、学术界和行业之间的交流提供了一个协作环境，促进了支持两国批准的美日临床试验的设计和实施。
