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South Korea Update: Release of IVD Clinical Performance Testing Institutions and More

South Korea’s regulator MFDS announced several regulatory changes that medical device manufacturers who do business in the country should review.

Korean building at night

December 8, 2023

South Korea’s medical device regulator, The Ministry of Food and Drug Safety (MFDS) announced several regulatory changes with which medical device manufacturers who do business in the country should become familiar.

MFDS updates IVD clinical performance testing institutions list

The MFDS released the list of designated IVD clinical performance testing institutions (list in Korean), through November 29, 2023. Notably, this list now includes 107 IVD clinical performance institutions following the designation of a new institution.

Korean translation of IMDRF medical device cybersecurity guidelines released

The Korean translation of medical device cybersecurity guidelines from the International Medical Device Regulators Forum (IMDRF), which include Principles and Practices for Medical Device Cybersecurity, Principles and Practices for the Cybersecurity of Legacy Medical Devices, and Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity, has just been released by MFDS.

MFDS releases various medical device guidelines

The MFDS has published the following guidelines for Korean Good Manufacturing Practices (K-GMP) for medical devices (links in Korean):

  • Medical Device Manufacturing and Quality Control Standards (GMP) Review Casebook (Guide-1316-01) - The new document introduces major cases relating to medical device GMP and addresses frequently asked questions.
  • Comprehensive Guidelines for Medical Device GMP (8th Edition) (Guide-0106-06) - Updated to reflect revisions made to the Medical Device Manufacturing and Quality Control Standards, as revised on May 12, 2023.

The MFDS also released the revised public official guideline, Convergence Medical Product Approval Review Procedures (Handbook-1005-02), which now reflects in vitro diagnostic medical devices and GMP operating procedures.


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