AMAR DocumentAMAR ordinary-route change declaration v1.0
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Registration-holder declaration for medical device and IVD registration changes in the ordinary route — v1.0 is published by Ministry of Health — Medical Device Division. This document is identified by its title; no separate official document code is recorded.
- Instrument
- Document
- Full name
- AMAR ordinary-route change declaration v1.0
- Category
- Registration
- Source publication
- Hebrew
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
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Registration-holder declaration for medical device and IVD registration changes in the ordinary route — v1.0
Complete Hebrew version 1.0 form dated 2 June 2024, expressly for device/IVD registration changes in the ordinary route. The material/non-material change matrix, administrative-change option, supporting-document and adverse-event/FSCA conditional statements, recognized-country conditions, European transition undertaking and signatures are retained. The matrix is a blank applicant declaration and does not itself approve or universally classify any proposed change. The printed date is the form-version date. The original editable Office bytes, all 3 pages of a separate workspace-bundled LibreOfficeDev layout render and the complete reviewed visible text are retained. The rendered pages are labelled as derived Office renders, not official PDF originals. Fresh direct retrieval matched the file already held on 20 October 2026; no new legal version is claimed. An uncompleted form is not an approval, and this source-only proposal does not establish present-day consolidated currentness or resolve a particular product-change case.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.