The Medical Imaging & Technology Alliance (MITA) met with international leaders on Wednesday at the US-China Joint Commission on Commerce and Trade (JCCT) Pharmaceuticals and Medical Devices Subgroup annual meeting to promote increased collaboration and access to life-saving medical imaging technology. Following MITA’s presentation to the Chinese State Food and Drug Administration (SFDA), subgroup co-chairs Peter Perez, US deputy assistant secretary for manufacturing, and Xu Youjun, director general of the China Department for International Cooperation, agreed to a 2012 work plan that includes a workshop to provide China with expert assistance in their transition to IEC 60601-1 third edition safety and performance standards later this year.
"MITA looks forward to working closely with SFDA through the JCCT in order to prepare for the standards workshop," said Zach Helzer, manager, MITA International Programs. "This important event further illustrates the combined commitment of the United States and China to delivering the highest-quality, most innovative medical care."
IEC 60601-1 is the basic safety and essential performance standard for medical electrical equipment. The third edition contains many improvements, driven by safety and progress in technology, and is far more comprehensive, covering additional product types and technologies.
"This agreement marks a significant turning point for MITA’s leadership in this international forum," said Helzer. "Our cooperative work with the Medical Device Task Force and our Chinese partners will lower barriers to trade and increase access to innovative life-saving imaging technologies in the Chinese market."
