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South Korea due to publish draft device regulations

This article was originally published in Clinica

Executive Summary

South Korea's draft revised medical device regulations were due to be published at the beginning of December. This follows nearly two years of industry lobbying for changes to the new regulatory requirements announced in February 1994, which were considered extremely onerous and of doubtful necessity (see Clinica No 611, p 10). The South Korean authorities intend to canvass industry opinion on the revisions.

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