Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices that utilize digital technology like AI, Big Data, and some software applications. The MFDS also said that it may require consultations with applicants to confirm the use of RWE prior to device approval.
The MFDS also points out that RWE must be reliable, and the data must be of high quality. To ensure this, the FDS says that the people gathering and examining the data must be qualified to do so. The RWE selection and exclusion criteria must be systematic. Finally, results from RWE must be double-checked and clearly explainable before it can be used.