Israeli Ministry of Health — Medical Devices Division
Israeli MoH · Israel · middle east
Israel's Ministry of Health (Misrad HaBri'ut) — leech therapy regulated under the Pharmacists' Ordinance with Medical Devices Division oversight; significant clinical use in reconstructive and microsurgery services.
Regulatory Profile
- Agency type
- national regulator
- Region
- middle east
- Country
- Israel
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.health.gov.il
Relevant Regulation Codes
- Pharmacists' Ordinance (New Version) 5741-1981 / פקודת הרוקחים
- Medical Devices Law 5772-2012 / חוק ציוד רפואי
- Medical Devices Regulations 5774-2014
Prescriber Requirements
- Israeli Medical Association-registered MD prescription required
- Registered nurse (אחות מוסמכת) application under physician's order; specialised wound-care nurse practitioners increasingly used
- Complementary medicine practitioners regulated under separate legislative framework; leech therapy primarily delivered in mainstream hospital settings
Supply Chain & GMP
AMAR — Israeli Medical Device Registration (Amar — Israeli Pharmaceutical-style registry); Hebrew-language labelling under MoH guidance. Cold chain 4–10 °C.
Import/Export Rules
Import licence from MoH Pharmaceutical Division + Ministry of Agriculture and Rural Development veterinary clearance. CITES via INPA (Israel Nature and Parks Authority).
Reimbursement Context
National Health Insurance Law (Hok Bituach Bri'ut Mamlachti, 1994) bundles inpatient leech therapy into hospital reimbursement; outpatient coverage varies by kupat cholim (health fund: Clalit, Maccabi, Meuhedet, Leumit).
Key Regulatory Documents
ASH Editorial Notes
Israeli plastic-surgery and microsurgery services (notably at Hadassah Medical Center, Sheba Medical Center, Rambam Health Care Campus) use leeches in venous-congestion salvage; integration with high-volume microsurgery practice positions Israel ahead of regional peers.
Related Jurisdictions
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
EDA — Egypt
Egypt's Egyptian Drug Authority (formed 2019, replacing the older CAPA / Central Administration of Pharmaceutical Affairs) — leech therapy regulated as a medical device with parallel traditional-medicine context.
SFDA — Saudi Arabia
Saudi Arabia's SFDA — leech therapy supervised under medical-device pathway, with Saudi Vision 2030 expansion of traditional/complementary medicine via NCCAM-KSA at the Ministry of Health.
MOHAP — United Arab Emirates
UAE Ministry of Health and Prevention — federal authority over health products; leech-specific regulation has not been independently verified by ASH.