Course Description

Medical Device Pre-Market Approval Process in Korea

Course Description:

This course provides a comprehensive review of the Korean medical device pre-market approval process requirements released in April 2012. It examines current regulatory documents, including different market access programs, classification systems, device categories, and manufacturing practices specific to Korea.

As part of this course, learners will be walked through the decision-making process of choosing which market access programs correlate to which medical devices (including exceptions to the rule). The course also includes a review of Korea FDA (KFDA) inspection policies.

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Apply the different requirements of Korean regulations for medical devices during your market access process
  • Understand the mechanism of categories and classifications of medical devices in Korea
  • Plan a Korean medical device listing or notification process for a device

Who Should Enroll:

Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Affairs Director, Clinical Project Manager, Export Manager, and R&D Engineeractive in the Korean market, and Korean importers or license holders new to the Korean medical device system are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

An understanding of the basic regulatory principles as outlined in IMDRF (formerly GHTF) is required, these can be found in the following courses:

  • pre-market Regulatory Model (ID N170).
  • Post market regulatory model (ID N171)
  • Supporting documents (ID N172)
  • International Implementation (ID N173)
  • Essential principles of safety and performance of medical devices (ID N182)
  • STED and its contents (ID N187)

In addition a detailed understanding of Quality systems requirements (ISO 13485), and Risk management (ISO 14971) are required to successfully achieve the above stated objectives. You can learn about these topics in the following WMDO courses:

  • ISO 13485: Foundations and Basic Principles (ID 196)
  • ISO 14971:2007 Review (ID 78)
  • Preparing Risk Management File and Which Techniques Apply (ID 83)
  • Integrating Risk Management Into Your Quality Management System (ID 94)
  • Implications of EN-ISO 14971:2012 (N189)

Subject Matter Expert:
Young Kim

60 min

Release date:

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