It’s not only a name change in fact.
Of course the Korean FDA became The MFDS (Ministry of Food and Drug Safety), but beyond that the agency has been promoted to a ministry level.
Following several concerns related to food safety this re-organization is supposed to tackle those issues. The ways to respond to safety accidents should be improved through better food safety management system. Additionally, modern means of administrative management should be implemented.
Without exactly knowing what “modern means of management” means, it is clear that there will now be a separation of duties between the Headquarters and the so called “Regional Food and Drug Administration” (RFDA).
The Headquarter will be responsible of the policy making and development while the RFDA will be in charge of the enforcement, surveillance, monitoring and evaluation.
Among the most important changes in the country is the oversight of on-site drug inspections by newly-created departments within regional authorities. In addition, the National Institute of Food and Drug Safety Evaluation (NIFDS) will be making changes meant to link the risk assessment procedures for food and drug products with the safety and efficacy evaluations of drug and device approvals.
According to the MFDS reorganization announcement, the RFDA will also set up discrete departments responsible for on-site inspections of medical device companies. Potentially this could help to improve the on-site inspection process for medical devices manufacturers.
It is difficult to predict any change impacting the registration and approval process of the medical devices so far.
The original communication can be found here.
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
