Formalizing its commitment to facilitating Sino-U.S. cooperation on standards for medical devices, the American National Standards Institute (ANSI) signed a Memorandum of Understanding (MoU) with China's National Institute of Food and Drug Control (NIFDC). Joseph Tretler Jr., ANSI vice president for international policy, signed the agreement on behalf of ANSI at a ceremony in Shanghai on October 16, 2014.
ANSI began a dialogue with NIFDC's China Medical Device Standardization Administration (CMDSA) in 2013, offering a platform for information exchange on the standards systems and processes in the U.S. and China. An initial seminar was held in Beijing in July 2013, bringing together Chinese experts and ANSI members in the field of medical devices [see related news item]. Since then, three more exchanges have been held in China and a delegation from CMDSA visited the U.S., and participants have discussed topics such as unique device identification (UDI), small-bore connectors, medical robotics technology, and standards for software as a medical device.
CMDSA 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 online to ANSI members.
Speaking at the signing ceremony, Mr. Tretler noted, "This cooperation provides an important vehicle for ANSI members to engage China. ANSI members represent the wide range of players involved in standards for medical devices, including government regulators, standards developers, conformance bodies, and medical device manufacturers. Like ANSI, our members believe this cooperation can lead to higher quality medical devices and facilitate trade between our two countries."
Following the MoU signing, the ANSI-CMDSA experts' exchange series continued with a discussion on standards for software as a medical device. ANSI members AAMI, Siemens, and Intertek presented on the U.S. standards landscape. In addition, participants heard from CMDSA and the Shanghai Center for Medical Testing and Inspection (CMTC) on the Chinese landscape.
For more information about the MoU signing, experts' exchange, or other ANSI China program activities, please contact Leslie McDermott, ANSI senior manager of international development, at [email protected].