In Depth: South Korea Medical Device Approval and Compliance


Posted April 2015.

With 50 million residents and high per capita spending on healthcare, South Korea is one of the largest Asian healthcare markets, roughly equal in size to India. All medical devices in South Korea must undergo an approval process overseen by the Ministry of Food and Drug Safety (MFDS).

This six-part video describes the steps for manufacturers to import their devices into South Korea, breaking it down into easy to follow steps. Once you begin the series you may skip to the next section at any time using the Playlist in the player window.

  • Overview of the Regulatory Process for Medical Devices in South Korea [runtime = 2:23]
  • Determining Your Medical Device Classification [runtime = 2:14]
  • Key Players in the MFDS Approval Process [runtime = 1:39]
  • Quality Management System Requirements [runtime = 3:01]
  • Registration Requirements [runtime = 3:04]
  • Final Steps [runtime = 3:03]