AMAR DocumentAMAR fast-route change affidavit 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 affidavit for class II/III and medium/high-risk IVD changes in the fast 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.
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- AMAR fast-route change affidavit v1.0
- Category
- Registration
- Source publication
- Hebrew
- Readable HTML
- 1 language version
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Registration-holder affidavit for class II/III and medium/high-risk IVD changes in the fast route — v1.0
Complete Hebrew version 1.0 affidavit dated 2 June 2024. The heading expressly limits scope to class II/III devices and medium/high-risk IVD in the fast registration route. The change matrix and all conditional undertakings are retained, including the separate lawyer-certification page. It is not a universal fast-route entitlement or blanket approval of an administrative change. The date is a form-version date rather than an inferred legal commencement 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. The derived class-heading plus glyph has a diamond-shaped appearance; literal source/native text is retained and this rendering limitation is disclosed in the author proof.
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.