AMAR DocumentAMAR CE/ISO 13485 update 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.
Declaration updating CE and/or ISO 13485 evidence in a registration file — 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 CE/ISO 13485 update declaration v1.0
- Category
- Registration
- Source publication
- Hebrew
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
Open a language version
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 updating CE and/or ISO 13485 evidence in a registration file — v1.0
Complete Hebrew version 1.0 declaration dated 12 May 2025 for updating CE and/or ISO 13485 evidence for class II/III devices and medium/high-risk IVD registered in the ordinary or fast route. The form preserves the distinct European transition and missing-valid-evidence-at-renewal conditions and the confirmation that remaining prior-declaration particulars are unchanged. It is not a generic manufacturer/holder transfer form. The date identifies the form version, not a newly inferred effective date. The original editable Office bytes, all 2 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.