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Technical Committee No |
TC11 |
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Status |
Active |
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Category |
Health Sector |
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Sub Category |
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$Resources:StandardType; |
Kuwaiti Standard |
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.
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Decision No |
51/2025 |
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Decision By |
From Ministers Office |
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Date of Meeting |
13-08-2025 |
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Approval Date |
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Decision Date |
12-11-2025 |
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Newspaper Publication Date |
07-12-2025 |
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Newspaper Number |
1768 |
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