In order to promote earlier market access of novel medical devices, Korea’s Ministry of Food and Drug Safety (MFDS) proposed changes for the “Regulation on Approval/Report/Review, Etc. of Medical Devices”. The proposed changes include:
- Designation criteria for rare-disease devices will include both finished products and developmental stage products. This will allow patients with rare diseases earlier access to innovative therapeutic products.
- Reduction of submission requirements for medical device software. The proposed amendments state that medical device software applications will only require descriptions of appearance, structure, function of each part/structure, and primary function of software.
The proposed changes must still be reviewed but if approved, will aim to improve market access and patient outcomes.