Israel is a global leader in life sciences innovation, with a highly advanced healthcare ecosystem and strong demand for cutting-edge pharmaceuticals, medical devices, and biotech products.
The Israeli Ministry of Health (MoH), through the Pharmaceutical Division and the Medical Device Unit, is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, in vitro diagnostics, and related health products in Israel. Israel maintains significant alignment with international standards (ICH, IMDRF, EU MDR/IVDR) and often recognizes EU/US approvals with Israeli-specific requirements (e.g., Hebrew labelling, local holder). Foreign manufacturers require product registration, import permits, GMP compliance, and a local authorized representative. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate MoH requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this high-tech, innovation-driven market.
Get Israel Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Israel-specific adaptation, scientific/technical review, and quality assurance for MoH submissions.
End-to-end support for MoH registration of medicines, medical devices, biologics, and health products in Israel, including recognition pathways.
Assistance with MoH import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for MoH quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to MoH, periodic safety reporting, and risk management in Israel.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with MoH post-registration requirements.
Hebrew/English labelling review, MoH-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local authorized representative requirements, MoH liaison, regulatory follow-up, and ongoing compliance management in Israel.
Strategic market entry planning, MoH pathway guidance (including EU/US recognition), regulatory intelligence on Israel’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Israel — from MoH product registration and import permits to pharmacovigilance, Hebrew labelling, and sustained market access.
Contact Our Israel Regulatory Experts