Inner and outer packaging and the accompanying leaflet are part of the regulated product
Under Jordan's device testing regulation the 'sample' (العينة) that is submitted for examination and against which conformity is judged is defined as the final product of any medical supply, steriliser, disinfectant or cosmetic preparation, expressly including the inner and outer packaging and the leaflet accompanying it. The leaflet (النشرة) and both packaging layers are therefore regulated elements of the product, not marketing material. Where a sample fails to satisfy the specifications stated in the technical file as regards the secondary packaging materials — the inner and outer packaging, the leaflet accompanying it and other specifications — or where the laboratory report records an observation (ملاحظة) on the sample, the Director General decides what to do with it on the recommendation of the committee, notwithstanding that the sample passed the test.
Source is Arabic; both excerpts are quoted verbatim with an English translation. The published PDF has a defective text layer: it carries kashida/letter-spacing runs and reverses the lam-alef ligature (لا is rendered as ال), so words such as 'النهائي' extract as 'النهلللللائي' and 'مستلزم' as 'مسللللللتلام'. The excerpts below repair those two mechanical artifacts only; no wording was changed. The Arabic wording was read against the glyph layout, and the repaired words were confirmed against the same regulation's Art. 2 and Art. 9 as cited by the registry's existing D09 fact dossier.sample-technical-file-conformity, which quotes the identical article. This fact concerns the label/leaflet as a regulated element of the product; it does not state a language requirement — see the unresolved note for D11.
