Medical Imaging and Technology Alliance Teams Up with Advanced Medical Technology Association
A series of activities created to overcome an array of obstacles between China and the United States, as well as an alignment of international standards for medical devices, was recently sponsored by the Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed).
These include: U.S.-China Joint Commission on Commerce and Trade (JCCT) Pharmaceuticals and Medical Device Subgroup meeting, and a two-day standards workshop that provided China's State Food and Drug Administration (SFDA) and Chinese industry representatives with additional expertise on IEC (News
) 60601-1 third edition - the internationally recognized standard for electrical medical equipment.
In order to increase the Chinese government's familiarity with the standard and further expedite their transition process, MITA and AdvaMed hosted a robust standards workshop on IEC 60601-1 third edition closely with the U.S. Department of Commerce and other industry partners, according to a recent article
The event also had industry experts and international consultants that came together in one place to discuss best practices and the future of healthcare.
Further, at the meeting, SFDA officials expressed appreciation for the opportunity to exchange information on this challenging regulatory area, and revealed that the Chinese system has been modeled on international best practices.
AdvaMed also emphasized a joint review mechanism for combination products based on the primary mode of action, and described the benefits of moving certain in-vitro diagnostic devices into lower-risk categories for regulatory purposes.
"China's transition to the third edition will usher in a more collaborative era of medical standards, driven by safety and international progress in technology," said Ralph Ives, AdvaMed executive vice president for Global strategy and Analysis.
Edited by Braden Becker
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