U.S. experts from ANSI members the Association for the Advancement of Medical Instrumentation (AAMI), the Advanced Medical Technology Association (AdvaMed), and the U.S. Food and Drug Administration (FDA), as well as Medtronic, provided an overview of U.S. medical device standardization, including private-sector standards and conformance programs, national and international participation, and the important role played by standards in supporting the FDA's mission. The event was attended by approximately 50 people representing Chinese and American industry, government, and academia.
Participants provided U.S. and Chinese perspective on both countries' plans to implement Unique Device Identification (UDI) systems, which are systems that enable the tracking and identification of medical devices. The workshop provided an ideal opportunity for technical exchange and identification of further areas for cooperation.
CMDSA, which reports to the Chinese Food and Drug Administration (CFDA), is responsible for technical research related to standards and conformity assessment for medical devices and has responsibility for managing many of China's national and international technical committees for medical devices. Additional background information on CMDSA is available to ANSI members.
The report from the workshop, including English translations of the presentations, is available in the ANSI Member library. Photos from the workshop are available online.
For additional information regarding the workshop, please contact Leslie McDermott, ANSI senior manager for international development, at [email protected].
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