By Stewart Eisenhart, Emergo Group
The Korea Food and Drug Administration (KFDA) is now the second Asian medical device regulator in recent weeks to announce a structural reorganization and name change, to the Ministry of Food and Drug Safety (MFDS), following the news that China’s State Food and Drug Administration is now the China Food and Drug Administration (CFDA).
Like the CFDA, the MFDS has been reformed as a ministry-level agency primarily in response to concerns about food safety. Operations of the MFDS have also been decentralized: The agency’s head office in Seoul will oversee policymaking and development, while regional offices throughout South Korea (collectively the Regional Food and Drug Administration, or RFDA) will handle enforcement, surveillance and monitoring in their assigned areas.
According to the MFDS reorganization announcement, the RFDA will also set up discrete departments responsible for on-site inspections of medical device companies. This move may help make medical device firms’ inspection processes more efficient in the long run. Beyond that, the effects of the MFDS reorganization on medical device registration and approval in Korea remain to be seen.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
