definiens: means Complete Diagnostic Kits and/or Component Systems which are Sold to End -Users who use them for diagnostic purposes and/or healt h care of a human subject and whose use is, in countries with an approval or registration process, Not Yet Approved by a regulatory agency having jurisdiction over the Sale of such products regardless of whether the labeling and/or other written materials accompanying such products contain recommendations and/or instructions for such use . In countries without an approval or registration process, the labeling has to clearly identify the intended use of the product ( e.g. for In Vitro Diagnostic Use ) . The Part ies agree that regulatory submissions for Not Yet Approved or Not Yet Registered In Vitro Human Diagnostic Products shall, in countries with an approval or registration process, be filed not more than twenty -four ( 24 ) months after the first commercial Sale of such Not Yet Approved or Not Yet Registered In Vitro Human Diagnostic Product