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Korea proposes elimination of in-country device testing requirements.

This article was originally published in The Gray Sheet

Executive Summary

KOREAN DEVICE REGULATION PROPOSED REVISIONS ELIMINATE IN-COUNTRY TESTING by Korean testing houses as a prerequisite to marketing clearance. An outline of proposed revisions to the program recently provided to the Health Industry Manufacturers Association indicates that in the future, the Republic of Korea Ministry of Health and Welfare (MOHW) plans to accept a "certificate of testing results" in lieu of in-country testing. The certificates could be issued only by "testing agencies designated by" MOHW, the outline says, but "certificates of testing results issued by foreign certified testing agencies which meet certain standards" would be "recognized."
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