In late 2016, Korea’s Ministry of Food and Drug Safety (MFDS) announced a revision draft for medical device clinical trials. Key revisions to the regulations include:
- For pilot clinical trials, the MFDS has eliminated the need to calculate the number of subjects and submit a statistical analysis plan. Pilot clinical trials are early-phase clinical trials conducted for a short term before the pivotal clinical trial is conducted. The elimination of statistical analyses in pilot trials will expedite the approval of pivotal trials, which should decrease the overall time needed to conduct clinical trials.
- The MFDS will now be allowed to seek advice from the National Evidence-based Healthcare Collaborating Agency (NECA) before approving medical device clinical trials. Clinical trials must also meet requirements of the New Health Technology Assessment (nHTA), which is regulated by the NECA. The nHTA regulations are required for new medical devices that introduce new procedures to the user. This revision should assist device companies in obtaining both regulatory and nHTA approval.
The addition of these two revisions is expected to accelerate the process of developing and selling medical devices in Korea.