[Report Reference] Food and Drug Administration Improvements for Innovation Medical Device Designation Evaluation System

"On "30/06/2025", the "Korea Food and Drug Administration (KFDA)" issued an update regarding "[Report Reference] Food and Drug Administration Improvements for Innovation Medical Device Designation Evaluation System". The KFDA revised the 'Innovation Medical Device Designation Procedure and Method, Standards, etc. Guidebook' to improve the designation evaluation system, expanding the scope of submitted materials, integrating and deleting certain evaluation criteria, and reducing the burden on businesses.