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.
For additional information regarding the workshop, please contact Leslie McDermott, ANSI senior manager for international development, at email@example.com.
Instructions for opening documents in the ANSI Member Library:
To view the CMDSA Background document or the ANSI Manufacturer Member Roundtable in China Summary Report, ANSI members can access the ANSI Member library with their My ANSI Login ID and password.
Forgot your Login ID? No problem: Retrieve your Login ID now
Forgot your Password? No problem: Retrieve your Password now
You will be asked to type in your email address and then to submit the form. A new password will be emailed to you with instructions on how to change it to a password of your choice.
If, after resetting your password, you are still having difficulty, please send an email to firstname.lastname@example.org. Please provide as much detail as possible in your email, including your user ID and password, so we can quickly resolve your problem.