Israel

In Israel, the primary regulatory authority responsible for the approval of health products, including pharmaceuticals, medical devices, diagnostics, and digital health solutions, is the Israeli Ministry of Health (MOH) through its Pharmaceutical Administration and the Medical Devices and Accessories Department (AMAR for devices). The principal governing legislation includes the Pharmacists' Ordinance (1981) and its associated regulations, the Medical Devices Law, and various ministerial directives issued by the MOH. Pharmaceuticals require registration in the National Drug Registry (NDR), while medical devices must obtain MOH approval prior to importation or commercial distribution. The general approval process involves submission of a dossier for scientific review, with the MOH also administering a Reference Drug Approval pathway that allows expedited registration for products already approved by recognized reference agencies such as the FDA, EMA, TGA, Health Canada, or Swissmedic.

Key submission requirements include the appointment of a local authorized representative or registered Israeli importer who assumes legal responsibility for the product in the market. Pharmaceutical dossiers are expected to follow the Common Technical Document (CTD) format in alignment with ICH guidelines. For medical devices, technical documentation must generally align with EU MDR standards or equivalent, and products bearing CE marking or FDA clearance may benefit from an abbreviated review track. Israel has implemented progressive reforms to harmonize its regulatory framework with international standards, including expanded use of reliance procedures and recognition pathways to reduce duplication of review, shorter timelines for orphan and innovative products, and ongoing digitalization of submission portals. The MOH has also strengthened post-market surveillance obligations and pharmacovigilance reporting requirements in recent years.

Public procurement of health products in Israel is centralized primarily through the Ministry of Health and the four main Health Maintenance Organizations (HMOs, known as Kupot Holim): Clalit, Maccabi, Meuhedet, and Leumit. These HMOs are publicly funded through the National Health Insurance Law (1994) and are obligated to provide a defined basket of health services and products to all enrolled citizens. The National Health Insurance basket, known as the Sal Briut, is updated annually by a government-appointed committee that evaluates new technologies, pharmaceuticals, and devices based on clinical evidence and cost-effectiveness analysis. Tenders for publicly funded pharmaceuticals and medical devices are conducted at both the national MOH level and individual HMO level, with pricing negotiations often influenced by reference pricing mechanisms and comparative effectiveness data. Hospitals within the public system, including government and semi-public institutions, also conduct independent procurement tenders governed by public procurement regulations requiring transparency and competitive bidding.

The private healthcare sector in Israel is well developed and plays a significant complementary role alongside the public system. Private hospitals, clinics, and supplementary insurance schemes (offered by the HMOs themselves) create an additional procurement channel for premium medical devices, diagnostics, and innovative health technologies. International donor or multilateral procurement channels such as those managed by UNICEF, the Global Fund, USAID, or Gavi are not materially relevant to the Israeli market given the country's high-income status and self-funded national health system. Israel does not apply formal local manufacturing preference policies in procurement, though domestic innovation is encouraged through research and development incentives administered by the Israel Innovation Authority. Pricing for reimbursed products is subject to MOH price controls and international reference pricing comparisons, making early health economic analysis an important component of any market access strategy.