🇰🇷South Korea Medical Device Regulations

Korean Medical Device Regulatory Framework

MFDS overview of the Medical Devices Act, its enforcement rules, risk classes I–IV, and the notification, certification, and approval pathways for devices marketed in Korea.

Permission, Notification and Review of Medical Devices

Detailed MFDS rules for device permission, notification, technical-document review, and changes to approved or certified products.

Medical Device Good Manufacturing Practice Regulations

Current English MFDS compilation of Korean medical device GMP regulations and standards for manufacturers and importers.