On November 7, 2024, the Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on the Approval, Notification, and Review of IVDs.
The purpose of the amendment is to reflect minor changes in the Enforcement Rules of the In Vitro Diagnostic Medical Device Act, and to reasonably improve and complement the current system.
This includes expanding the recognition of clinical performance data in cases where it is difficult to obtain specimens domestically.
The key amendments to the Regulations on the Approval, Notification, and Review of IVDs are as follows:
1. Expansion of Reporting Deadline for Minor Changes:
- In line with the amendments to the Enforcement Rules of the IVD Act, the regulations allow for the reporting of minor changes on a rolling basis and extend the quarterly reporting period.
2. Expansion of Recognition of Clinical Performance Data in Cases Where Specimen Collection is Difficult Domestically (Articles 2, 6, 12, 14, 27, and 62-2):
a) In cases where the number of clinical cases of the target disease due to the analyte is low, and is difficult to secure specimens for clinical performance test, data using artificial specimens will be accepted as clinical performance data.
b) Those wishing to conduct the above clinical performance tests can request a meeting with the MFDS, such as via video conference. If approved, the use of artificial specimens will be noted in the approval documentation, and it will be required to consider this when using such specimens.
3. Term Revision (Article 32):
- The term “Re-evaluation” will be revised to “Post-Market Surveillance”.
Please refer to the attached document below.
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