AMAR REG-2023REG-2023/04
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
REG-2023/04 is the official AMAR identifier for “Declaration-route medical-equipment registration procedure — REG-2023/04”. REG-2023/04 is the official identifier AMAR uses for this instrument.
- Instrument
- REG-2023
- Full name
- REG-2023/04
- Category
- Registration
- Source publication
- Hebrew
- Readable HTML
- 1 language version
- Published
- 2023-09-03
- Effective
- —
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Declaration-route medical-equipment registration procedure — REG-2023/04
Complete 22-page Hebrew REG-2023/04 procedure with registration, renewal and change sections and all declaration annexes. The printed scope is class I devices (including Is, Im, Ir) and low-risk IVD (Other under IVDD/class A under IVDR), with stated recognized-country and route conditions. Physical pages 21–22 retain the full change-declaration annex including holder/manufacturer name/address/model fields and conditional undertakings. It is not a universal route for all risk classes, a holder-transfer approval, or an import procedure. The cover explicitly prints publication 3 September 2023; no absolute effective date is invented. The complete official PDF and all original physical page images are retained; native PDF text is an explicitly incomplete search layer, not a verified full transcription. Fresh direct download on 26 October 2026 matched the bytes already held on 20 October; this is preservation of an unadmitted expression, not evidence of a new legal version. Present-day legal currentness and case-specific change requirements are not established by this source-only capture.
REG-2023/04 is the official identifier AMAR uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.