On November 22, 2019, the American National Standards Institute (ANSI) hosted a bilateral meeting with a delegation from China's National Medical Products Administration (NMPA). Under the newly formed State Administration for Market Regulation (SAMR), NMPA is the Chinese regulatory body for Chinese drugs and medical devices and has the responsibility of developing production standards for medical devices to ensure quality and safety. Led by Wang Zhexiong, the director-general of NMPA's department of medical device supervision, the delegation was invited by the United States Trade and Development Agency (USTDA). U.S. industry representatives had the opportunity to showcase their technologies and capabilities, as well as discuss opportunities for partnership and collaboration.
During the meeting, the Chinese delegation met with ANSI staff from the international development team and China program, as well as representatives from the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer.
The meeting promoted dialogue on U.S. and Chinese standardization, consensus standards, and risk management in medical devices. ANSI spoke about the U.S. standardization system and China program activities. Joseph Lewelling, AAMI's vice president of emerging technology and health IT, provided background on AAMI's role in medical device standardization. He discussed the U.S. process for medical device standardization and described the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) committees and subcommittees that AAMI administers. Subject matter expert Patty-Krantz-Zuppan from Medtronic led a presentation on IEC 62304, the international standard on medical device software and risk management. NMPA's Mu Ruihong provided an introduction of medical device standards management in China.
The presentations sparked conversation on the differences and similarities in medical device standard development, which helped both countries see how they could better collaborate in the future. In addition, each group discussed potential future challenges of medical device standardization, especially the complexity of standards for health IT. This bilateral meeting increased knowledge sharing and established a propitious foundation for the continuation of U.S.-Chinese collaboration with medical device standardization.
Since 2018, the Chinese government has proactively reorganized its regulatory oversight and introduced several policies to regulate the medical device industry. Through the USTDA-funded U.S.-China Standards and Conformity Assessment Cooperation Program, ANSI coordinated and co-organized two medical device standardization workshops in partnership with NMPA and the U.S medical device industry in 2018 and 2019. These workshops aimed to help U.S. industry navigate pre-market registrations and testing requirements, discuss the interplay between voluntary standards and market approval in the U.S., and highlight the latest progress on standards development for medical robotics in China, the U.S., and around the world. Additionally, ANSI maintains a Memorandum of Understanding (MOU) with the National Institutes for Food and Drug Control (NIFDC) in China. The MOU facilitates dialogue for information exchange on the standards systems and processes related to the U.S. and China.
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