Korea Introduces New Pilot Program to Ease Medical Device Registration

Korean regulatory authorities have recently begun a pilot program that will simplify the medical device registration process. Under this new program, medical device companies whose products meet the pilot program conditions can submit a single application to the Korean Ministry of Food and Drug Safety (MFDS). The MFDS will then collaborate with the Ministry of Health and Welfare (MOHW) to approve the medical device and conduct a health technology assessment. If the medical device is approved, the MFDS will issue a single certificate containing the approval and the health technology assessment.

Currently, the MFDS and the MOHW issue separate approvals, which sometimes leads to discrepancies and lengthens registration times. Korean regulators hope that this new pilot program will expedite the approval process and reduce costs for medical device companies. The pilot program will run until July 2016.