Israel medical device regulations
Official sources linkedAMAR rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| REG-2024/03 | Registration Procedure - Documents Required for Registration AMAR procedure REG-2024/03 (Hebrew official text) on documents required for registration in the medical equipment register. Ingested sections 1–8, 6.א/6.ב, and Annex 1 from the official PDF. Published 2 June 2024, in force 1 January 2025, last change-history date 12 May 2025. | Registration | 1 January 2025 | Official |
| AMAR Forms | Medical Equipment Division Forms Official forms for medical device registration, import permits, and other AMAR services. Includes application forms for device registration and renewal. | Registration | 2024 | Official |
| AMAR Guidelines | Medical Equipment Division Guidelines Collection Collection of official guidelines from the Medical Equipment Division including registration procedures, classification requirements, and compliance documentation. | Registration | 2024 | Official |
| Import Guide | Medical Equipment Import Requirements Guide for importing medical equipment to Israel. Import through customs requires Ministry of Health approval per the Free Import Order. Details products requiring import license or compliance verification. | Registration | 2024 | Official |
| About Medical Equipment Division | About the Medical Equipment Division Overview of the Medical Equipment Division responsibilities including device registration, import/export permits, and market supervision. Israel accepts CE and FDA certified products via reference country pathway. | General | 2012 | Official |
| Medical Equipment Division | Medical Device Division - Ministry of Health The Medical Device Division (AMAR) handles registration, import permits, marketing supervision, and export documentation for medical devices in Israel. Established in 1993 under the Medical Equipment Law of 2012. | General | 1993 | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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