Korea Changes Regulations to Allow Early Market Access of New Medical Devices

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:

  1. 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.
  2. 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.