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Technical File Preparation for Korea MFDS Submissions

ANSWERED ON THIS PAGE:

  • Do Korean device submission requirements vary by device classification?
  • What device information is included in a Korean Technical File?
  • Which medical devices require clinical data with their device submission?

Medical devices and IVDs are separated into four classes of increasing risk in Korea: Class I, II, III, and IV per the MFDS process chart. While Class I devices are eligible for a simplified notification process, Class II, III, and IV devices require the preparation of a Technical File, which is submitted as part of the medical device registration with the Korean Ministry of Food and Drug Safety (MFDS). Emergo's team in Seoul, South Korea has the expertise to help you prepare a complete technical file for your MFDS device submission.

Types of medical device technical files in Korea

The Technical File contains information about the medical device design, materials, intended use, manufacturing methods, and so on. The Korean Technical File is similar to a European Technical File or US FDA 510(k) submission. Class II and higher devices will need to submit testing information with their Technical File, and most products will require additional performance testing to meet Korean requirements. Additionally, Class IV devices require a Summary Technical Document (STED) submission, in addition to the standard application.

Class II, III, and IV medical devices with new technology or without a Substantially Equivalent (SE) device must submit clinical data to MFDS for review, in addition to the standard technical file. The Clinical Data Review application (formerly Safety and Efficacy Review – SER) is a comprehensive submission type, similar to a European Design Dossier or US FDA PMA submission.

Emergo can prepare your Korean medical device technical file

Our experienced team in Seoul has been assisting medical device and IVD companies with MFDS submissions and Technical File preparation for many years. Our services include:

  • Classification determination
  • Assistance with identifying a Substantially Equivalent device
  • Reviewing existing technical documentation prepared for the medical device to see if it meets Korea's requirements
  • Support with determining appropriate Type Testing to satisfy MFDS requirements
  • Preparation of the Technical File and Clinical Data Review application
  • Filing with MFDS

We also assist companies without a physical location in South Korea with Korea Good Manufacturing Practice (KGMP) and Korea License Holder (KLH) representation.

 

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Common questions

What is required for an MFDS Clinical Data Review application?

For products that require a Clinical Data Review, a more robust application is required, including clinical data information. Typically Class III and IV devices require data from human studies, while Class II devices may be able to provide scientific literature instead.

How is substantial equivalence defined in South Korea?

To be substantially equivalent in Korea, the device should have an equivalent design, mode of action, performance, intended use, and method of use.