MFDS Reappointed as Chair of the Working Group in the Global Medical Device Regulatory Cooperation Forum
Attended GHWP Annual General Meeting... Strengthening Global Leadership
The Ministry of Food and Drug Safety (MFDS) announced on the 24th that it attended the annual meeting of the Global Harmonization Working Party (GHWP) held in Riyadh, Saudi Arabia from the 13th to the 16th (local time) to strengthen the international medical device cooperation network and explore export support measures for domestically produced products.
GHWP is a cooperative organization established in 1996 for the international harmonization of medical device regulations, currently comprising 33 member countries worldwide, including the United States, Japan, China, and Singapore. It is composed of a Technical Committee and nine working groups, and Korea served as the chair country from 2015 to 2017.
At this meeting, the MFDS was recognized for its excellent regulatory capabilities in approval and review, and was reappointed as the chair of the 'Medical Device Approval Working Group (Working Group 1)'.
Additionally, GHWP began discussions to adopt the MFDS's 'Guideline for Approval and Review of Artificial Intelligence-based In Vitro Diagnostic Medical Devices (Software)' as an international common guideline. Furthermore, at this meeting, the MFDS's 'Guideline for Approval and Review of Artificial Intelligence Medical Devices' was added as an important reference guideline to the guidelines applied by GHWP member countries when changing medical device approval details.
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Meanwhile, the meeting selected 'Expansion of Digital Health Device Applications' as a special topic for discussion. In particular, representatives from Korea's MFDS, industry, and hospitals participated as speakers to present advanced domestic regulatory systems and cases of innovative product utilization. Interest was drawn to the first domestically approved digital therapeutic device (DTx) supported by tailored regulatory assistance such as proactive guideline preparation, smart hospitals applying digital technology, and various cases of artificial intelligence medical device utilization.
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