New South Korean device regulations ready by July 1996
This article was originally published in Clinica
Changes to the South Korean medical device regulations will hit companies by mid-1996, Richard Larkin, director of international regulatory affairs at Bard International, told delegates at a HIMA meeting in Washington, DC, on December 7th. Comments on the proposed revisions, an outline of which was circulated at the meeting, are sought by the US government by the end of the year. The Korean Ministry of Health and Welfare, which has worked with the US in developing the regulations, plans to finalise them by July 1st, 1996.