Medical Device Clinical Trial Institutions Must Undergo Simultaneous Written and On-Site Inspections Every 3 Years

[Asia Economy Reporter Lee Gwan-ju] From this year, medical device clinical trial institutions will undergo simultaneous written and on-site inspections every three years.

The Ministry of Food and Drug Safety announced on the 16th that it will reorganize the inspection system for all institutions that have conducted medical device clinical trials with at least two performances after obtaining approval from their own Institutional Review Board (IRB).

The IRB is a permanent committee independently established within the trial institution to protect the rights and safety of subjects participating in clinical trials. It reviews clinical trial protocols or amendment plans, methods of obtaining written consent from subjects, or information provided, and continuously verifies and inspects these aspects.

This year, the inspection targets are 25 institutions with many clinical trial performances conducted solely through their own IRB review. Next year, 29 institutions will be inspected, and in 2025, 23 institutions are planned for inspection. Institutions with one or fewer clinical trial performances and those subject to inspection this year as pharmaceutical clinical trial institutions are excluded.

The Ministry of Food and Drug Safety inspects by reviewing the written evaluation forms and related certification documents self-checked by the clinical trial institutions, then directly visiting the site to verify the institution's operational status and compliance with relevant laws for individual clinical trials. Inspection results are classified as 'Normal' or 'Insufficient'; normal results lead to re-inspection after three years, and insufficient results after one year.

The Ministry stated, "This reorganization of the clinical trial institution inspection system is expected to enhance the safety and reliability of domestic clinical trials, eliminate management blind spots, and help ensure the safety of subjects."

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