Israel: Ministry of Health Supplement Notification, AMAR Medical Devices and Hebrew Labelling Discipline
Israel operates a relatively pragmatic regulatory regime overseen by the Ministry of Health (משרד הבריאות, MoH) through its Food Service (Sherut Mazon) for food and supplements and the AMAR Medical Devices Division for medical devices.
In Short
- The Public Health (Food)(Food Supplements) Regulations 1997 (תקנות בריאות הציבור (מזון) (תוספי מזון)) define food supplements as concentrated sources of nutrients or…
- The Medical Devices Regulations 5772-2012 (effective 2013) created the AMAR (אגף ציוד רפואי) Medical Devices Division within the MoH and the AMAR Registry as the…
- Hebrew is the mandatory primary labelling language for food, supplements and medical devices placed on the Israeli market, with Arabic and English supplementary text…
Dietary supplements are governed by the Public Health (Food)(Food Supplements) Regulations 1997 and require pre-marketing notification with the MoH Food Service; medical devices follow the Medical Devices Regulations 2013 and AMAR registration; the new Food Protection Law 5776-2015 modernised general food law in line with FAO/WHO Codex direction. Hebrew is the mandatory primary labelling language with Arabic and English supplementary, kosher certification is commercially essential for the domestic market, and the kosher (mehadrin/badatz tiers) and halal supply chains drive supplier qualification well beyond regulatory minima. This guide covers supplement notification, AMAR medical device registration, label/kosher discipline and the practical realities of operating in Israel.
Food Supplement notification under the 1997 Public Health Regulations
The Public Health (Food)(Food Supplements) Regulations 1997 (תקנות בריאות הציבור (מזון) (תוספי מזון)) define food supplements as concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form to supplement normal diet, and govern notification, composition, labelling and claims. Pre-marketing notification with the MoH Food Service is required for each supplement SKU before placement on market — the file covers ingredient list with quantitative declaration of active substances, manufacturing site GMP evidence, finished-product specification, label artwork in Hebrew, evidence supporting claimed structure-function statements, target population, recommended daily dose with safety substantiation and country-of-origin documentation.
More on food Supplement notification under the 1997 Public Health Regulations
The MoH operates positive lists for vitamins and minerals with upper daily-intake limits (broadly aligned with EU food supplements directive 2002/46 plus Israel-specific national positions) and reviews novel botanicals, amino-acid blends, probiotic strains and bioactive ingredients case-by-case. Disease-treatment, prevention and drug-like claims trigger reclassification to medicinal product (requiring marketing authorisation through the Pharmaceuticals Division — a far heavier pathway). Typical notification timeline is 30-90 working days depending on novelty; complete files for routine vitamin/mineral combinations clear faster, while novel ingredients may extend to 6+ months with expert committee review.
AMAR medical device registration and the 2013 Medical Devices Regulations
The Medical Devices Regulations 5772-2012 (effective 2013) created the AMAR (אגף ציוד רפואי) Medical Devices Division within the MoH and the AMAR Registry as the formal device-listing system. Devices are classified by risk (I, IIa, IIb, III mirroring the EU MDR risk tiers), and Israel accepts reference-country approvals — FDA 510(k) or PMA, EU MDR CE marking with a notified-body certificate, Health Canada licence, Japanese PMDA marketing authorisation or TGA registration — as the technical basis for AMAR registration, dramatically simplifying the dossier for products already approved in major reference markets.
More on aMAR medical device registration and the 2013 Medical Devices Regulations
The application covers proof of reference-country approval, Israeli authorised representative appointment, Hebrew labelling and instructions for use, post-market surveillance plan and incident-reporting commitment. Class I devices follow a simplified declaration pathway with AMAR notification; Class IIa/IIb/III follow the full registration pathway with technical review proportionate to risk class. Registration validity is typically 5 years with renewal required. Without a valid AMAR registration the device cannot be imported, distributed or used in Israeli healthcare. Post-market obligations include incident reporting to AMAR within prescribed timelines (typically 10 working days for serious incidents), Field Safety Corrective Action (FSCA) coordination with AMAR, and annual reporting for higher-risk classes.
Hebrew labelling, kosher discipline and the multilingual market reality
Hebrew is the mandatory primary labelling language for food, supplements and medical devices placed on the Israeli market, with Arabic and English supplementary text permitted (and commercially useful for the Arab Israeli market and tourist channels). Mandatory information aligns broadly with Codex and the EU FIC framework — product name, ingredient list, allergen declaration, nutrition information, net quantity, manufacturer and importer details, country of origin, manufacturing/expiry date, storage conditions, supplement-specific recommended daily dose and any notified claims, plus the prescribed supplement statement ('Not a substitute for a balanced diet' or equivalent).
More on hebrew labelling, kosher discipline and the multilingual market reality
Kosher certification is commercially essential for >85% of the Israeli domestic market — the major certifying bodies (Chief Rabbinate of Israel, Badatz Edah HaChareidis, OU Israel, OK Israel and others) operate tiered kosher schemes (mehadrin = strictest, regular kosher, kosher for Passover with specific Passover-eligible ingredients only) that drive supplier qualification, manufacturing-line dedication or kosherisation between runs, ingredient sourcing (gelatin from kosher slaughter, dairy/parve/meat segregation), packaging-material kosher certification and seasonal Passover production planning. Halal certification serves the Arab Israeli and export-to-Muslim-market channels. Cosmetic, personal-care, supplement and food brand-owners typically maintain parallel kosher and halal supply chains with full traceability documentation back to the certifying body.
Import, post-market surveillance and Israel-specific commercial realities
Imports clear through MoH Border Inspection (food and supplements) and AMAR import authorisation (medical devices) with documentary checks (notification or registration, certificate of free sale from country of origin or reference market, certificate of analysis, kosher certificate where claimed) plus risk-based physical inspection and sampling. The MoH Food Service operates retail surveillance with sampling against the notified specification; AMAR conducts post-market device surveillance including incident analysis and field-action coordination.
More on import, post-market surveillance and Israel-specific commercial realities
Non-compliance triggers product seizure, notification or registration suspension, administrative fines and — for serious safety violations or fraud — criminal liability under the Public Health Ordinance and Medical Devices Regulations. Commercial realities include a concentrated retail landscape (Super-Pharm and Be Pharm dominate supplement/pharmacy channels; Shufersal and Rami Levy dominate grocery), strong direct-to-consumer e-commerce growth, Hebrew-only digital marketing in the domestic market, kosher-certification scrutiny as a marketing-funnel filter, and a sophisticated consumer base that values clinical substantiation, kosher tier and origin-country signalling. Reference-country approvals (FDA, EU, Health Canada) carry significant brand weight in the regulated-product categories.
Questions
Does Israel accept EU CE-marked devices without AMAR review?
No — AMAR registration is required even for CE-marked devices, but the dossier is dramatically simplified for products with valid EU MDR CE approval (or FDA 510(k)/PMA, Health Canada, PMDA, TGA). AMAR conducts an administrative review of the reference-country approval plus Israel-specific elements (Hebrew labelling/IFU, Israeli authorised representative, post-market surveillance commitment) rather than a full de-novo technical review. Class I devices follow a simplified notification path; higher classes follow proportionate review.
Is kosher certification legally mandatory in Israel?
No — kosher certification is not legally mandatory for most food and supplements, but it is commercially decisive for the domestic market where >85% of consumers actively seek kosher product and the major retail chains (Super-Pharm, Shufersal, Rami Levy) effectively gate shelf space by kosher certification. Pharmacy and supplement-specialty channels follow the same pattern. Non-kosher product is viable only in tourist channels and certain Tel Aviv urban segments. Kosher tier (mehadrin > regular kosher) drives shelf placement and premium pricing within the kosher market.
Can we use an English-only label with a Hebrew sticker?
A Hebrew-language sticker overlaying or supplementing English-only primary artwork is technically acceptable for import compliance provided the sticker covers all mandatory Hebrew elements (product name, ingredient list, allergen declaration, nutrition information, recommended daily dose for supplements, manufacturer/importer details, expiry date, storage conditions) without obscuring mandatory non-Hebrew information, and is applied prior to placement on market. In practice, retailers strongly prefer fully-printed Hebrew primary artwork — sticker-only labelling reads as imported afterthought and undermines premium positioning. Major brands invest in Hebrew-primary artwork for the Israeli SKU.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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