On December 23, 2024, the Ministry of Food and Drug Safety (MFDS) announced a partial amendment to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act.
The purpose of this amendment is to establish the necessary provisions for implementation in line with the revision of the In Vitro Diagnostic Medical Devices Act, which allows clinical performance testing to be conducted at institutions other than designated clinical performance testing institutions, depending on the characteristics of the testing.
The revised contents of the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act are briefly as follows.
ü Amendment to Article 13(2)(3): The following provision is updated.
3. Matters regarding the name and location of the clinical performance testing institution under Article 8(1) of the Act (hereinafter referred to as "clinical performance testing institution").
[In cases where clinical performance testing is conducted by an institution other than a clinical performance testing institution under the proviso of Article 7(3)(1) of the Act (hereinafter referred to as "clinical performance testing participating institution"), the reasons, the name and location of the participating institution, and matters related to its management and supervision shall be included].
ü Amendment to Article 16(1)(3): The term "clinical performance testing institution" is revised to "clinical performance testing institution and clinical performance testing participating institution."
ü Addition of Article 17(1)(1-2): A new provision is added as follows.
1-2. Clinical performance testing shall be conducted at a clinical performance testing institution or a clinical performance testing participating institution designated by the Minister of Food and Drug Safety.
[In cases where clinical performance testing is conducted at a clinical performance testing participating institution, the clinical performance testing institution shall manage and supervise the participating institution].
Please refer to the attached document below.
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