Israel Product Registration & Certification
Important Notes
- Mandatory Hebrew Language Requirements: All technical documents, labels, and instructions must be in proper Hebrew requiring professional translation agencies
- Import License System: Medical devices must obtain import licenses from Israeli Ministry of Health Medical Device Division for import and sale
- Dual Legal Representative Requirements: Must appoint both Israeli Authorized Representative and importer for regulatory and commercial responsibilities respectively
- Limited International Certification Acceptance: Accepts CE certification and FDA approval as technical basis but requires supplementary Israeli-specific labeling and documentation
- Post-market Surveillance Obligations: Must establish complete PMS system including adverse event reporting, quality tracking, and periodic safety reports after registration
- VAT Compliance: All commercial transactions subject to 17% Value Added Tax (VAT) requiring importer tax registration and declarations
- Clinical Data Requirements: High-risk medical devices may require Israeli local clinical trial data or sufficient clinical literature support
- Registration Validity Management: Import licenses have defined validity periods (typically 5 years) requiring renewal application 6 months in advance
Israel Specific Requirements
- Strict Hebrew Labeling System: All product information must be in Hebrew reflecting Israeli language policy and consumer protection
- Mandatory Dual Local Representative System: Requires both Israeli Authorized Representative (technical responsibility) and importer (commercial responsibility)
- EU Classification System Adoption: Medical device classification essentially adopts EU MDD/MDR classification maintaining international standard alignment
- Innovative Medical Device Priority: Establishes expedited approval pathways and technical support for digital health and innovative products
- International Certification Localization Path: Accepts CE/FDA as base certifications but requires Israeli-specific registration and labeling compliance
- Stringent Post-market Supervision: Implements strict post-market surveillance requiring mandatory adverse event reporting and periodic safety updates
- Registration Validity Management System: Import licenses have defined validity periods requiring corporate tracking systems for renewal
- Technology Transfer & Local Collaboration: Encourages foreign manufacturer partnerships with Israeli companies promoting technology transfer and local production
Medical Devices Registration
Regulatory Requirements
- Medical Device Import License
- Classification according to risk classes (I, IIa, IIb, III)
- Complete Hebrew technical documentation
- Quality Management System Certificate (ISO 13485)
- CE Marking or FDA Approval (as technical file basis)
- Clinical Evaluation Report (for Class IIb and III devices)
- Biocompatibility Test Reports (for body-contact devices)
- Performance Verification Data
- Risk Assessment Documentation
- Sterilization Validation Reports (if applicable)
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- MOH Medical Devices Division assessment
- Local authorized representative appointment
- Import license obtainment
- Post-market surveillance establishment
Registration Timeline
8-24 months (depending on product class and complexity)
Official Fees
ILS 25,000 - 350,000 (including application fee, technical assessment fee and registration fee)
Service Fees
$18,000 - $65,000
Regulatory System Overview
Israel MOH
Israel Ministry of Health (MOH)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and dietary supplements. Medical Devices Division specifically handles medical device import licensing, technical assessment and post-market surveillance.
Innovation Authority
Israel Innovation Authority (IIA)
Supports medical technology innovation and development, provides technical assessment, R&D funding support and market access guidance for innovative medical devices, promoting Israel medical technology industry development
Standards Institution
Standards Institution of Israel (SII)
Responsible for developing Israeli product standards and conducting certification, ensuring product quality and safety comply with Israel National Standards (SI Standards), providing product testing and quality management system certification services
Medical Devices Registration Process
Product Classification
Determine risk classification according to Israel medical device classification rules (Class I, IIa, IIb, III), largely adopting EU MDD/MDR classification system
Technical Documentation
Prepare complete Hebrew technical documentation including product specifications, test reports, clinical data, risk assessment
Quality Management System
Provide valid ISO 13485 certificate or undergo MOH quality system audit
Local Representative
Appoint authorized representative in Israel responsible for MOH communication and product registration
MOH Application
Submit import license application to MOH Medical Devices Division through authorized representative
Technical Assessment
MOH conducts technical file evaluation, safety assessment and conformity review
Import License
Receive Medical Device Import License, typically valid for 5 years
Cosmetics Registration
Regulatory Requirements
- Cosmetic Import License
- Complete Cosmetic Product Safety Report (CPSR)
- Compliance with Israel Cosmetic Regulations (Public Health Regulations - Cosmetics)
- Hebrew product labeling and instructions
- Good Manufacturing Practice (GMP) Certificate
- Product Stability Test Reports
- Microbiological Testing Reports
- Non-animal Testing Declaration
- Product Information File
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Technical documentation preparation
- Import license application
- Label compliance review
- Market access completion
Registration Timeline
4-12 months
Official Fees
ILS 12,000 - 85,000 (including application fee, assessment fee and registration fee)
Service Fees
$9,000 - $25,000
Regulatory System Overview
Israel MOH
Israel Ministry of Health (MOH)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and dietary supplements. Medical Devices Division specifically handles medical device import licensing, technical assessment and post-market surveillance.
Innovation Authority
Israel Innovation Authority (IIA)
Supports medical technology innovation and development, provides technical assessment, R&D funding support and market access guidance for innovative medical devices, promoting Israel medical technology industry development
Standards Institution
Standards Institution of Israel (SII)
Responsible for developing Israeli product standards and conducting certification, ensuring product quality and safety comply with Israel National Standards (SI Standards), providing product testing and quality management system certification services
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Israel cosmetic regulations permitted lists and prohibited substances
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) by qualified toxicologist
Technical Documentation
Prepare complete technical file including product formulation, manufacturing method, safety evidence
Import License Application
Submit cosmetic import license application to MOH Pharmacy Division or relevant authority
Label Compliance
Ensure labels fully comply with Hebrew requirements and Israel cosmetic labeling regulations
Local Responsible Person
Appoint responsible person and importer in Israel
Dietary Supplements Registration
Regulatory Requirements
- Dietary Supplement Import License
- Ingredient safety and quality evidence
- Compliance with Israel Food Supplement Regulations
- Hebrew labeling and instructions
- Good Manufacturing Practice (GMP) Certificate
- Ingredient Analysis Reports
- Stability Study Data
- Active Ingredient Quantitative Analysis
- Heavy Metals and Contaminants Testing
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- Import license application
- Label compliance review
- Market access completion
Registration Timeline
5-14 months
Official Fees
ILS 15,000 - 120,000 (including application fee, assessment fee and registration fee)
Service Fees
$12,000 - $35,000
Regulatory System Overview
Israel MOH
Israel Ministry of Health (MOH)
Comprehensively responsible for registration approval, quality supervision, and market regulation of medical devices, pharmaceuticals, cosmetics, food and dietary supplements. Medical Devices Division specifically handles medical device import licensing, technical assessment and post-market surveillance.
Innovation Authority
Israel Innovation Authority (IIA)
Supports medical technology innovation and development, provides technical assessment, R&D funding support and market access guidance for innovative medical devices, promoting Israel medical technology industry development
Standards Institution
Standards Institution of Israel (SII)
Responsible for developing Israeli product standards and conducting certification, ensuring product quality and safety comply with Israel National Standards (SI Standards), providing product testing and quality management system certification services
Dietary Supplements Registration Process
Product Classification
Determine product falls under dietary supplement category according to Israel Public Health Protection (Food) Law
Technical Documentation
Prepare Hebrew technical documentation including ingredient analysis, safety evidence, efficacy claim support
Ingredient Compliance
Verify all ingredients are permitted in Israel dietary supplements and comply with maximum dosage limits
Import License Application
Submit dietary supplement import license application to MOH Food Division
Label Review
Ensure labels comply with Israel food labeling regulations and Hebrew requirements, including nutrition facts and health claims
Quality Documentation
Provide GMP certificate, quality control procedures and product specification documents