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Medical Devices / Regulatory Affairs

IMDRF Gains 10th Member: Korea’s Ministry of Food and Drug Safety

Dec. 29, 2017
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Korea’s Ministry of Food and Drug Safety has become the 10th official member of the International Medical Device Regulatory Forum.

Korea joins founding member countries — the U.S., Europe, Canada, Australia, and Japan — as well as Brazil, China, Russia, and Singapore in the effort to harmonize medical device regulations via guidance documents, standards, and auditing practices.

A cornerstone of the forum’s strategy is the Medical Device Single Audit Program, which recognizes a common set of requirements for audits to prevent confusion and reduce audit times.

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