American Society of Hirudotherapy

Egyptian Drug Authority

EDA · Egypt · middle east

Regulatory jurisdiction profileJurisdictional reference
Medical device clearednational regulator

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.

Regulatory Profile

Agency type
national regulator
Region
middle east
Country
Egypt
Leech status
medical device cleared
Last ASH review
2026-05-25
Website
https://www.edaegypt.gov.eg

Relevant Regulation Codes

  • Law No. 151 of 2019 — Establishment of the Egyptian Drug Authority
  • Ministerial Decree No. 296 of 2009 — Medical devices regulation
  • Pharmacy Practice Law No. 127 of 1955 (as amended)

Prescriber Requirements

  • Egyptian Medical Syndicate-registered MD prescription required
  • Nursing application under physician's order per Nursing Syndicate scope
  • Hijama (cupping) practitioners are licensed under separate Ministry of Health programme; leech therapy is not part of hijama scope but operates alongside it

Supply Chain & GMP

EDA Medical Device Registration; importer requires Egyptian Drug Authority licensing. Arabic-language labelling mandatory.

Import/Export Rules

Import via EDA approval + General Authority for Veterinary Services clearance. CITES via EEAA (Egyptian Environmental Affairs Agency).

Reimbursement Context

Universal Health Insurance System (rolling out 2018–2032) covers inpatient procedures under DRG-style bundling; outpatient hirudotherapy is private-pay.

Key Regulatory Documents

  1. Law No. 151 of 2019 — Establishment of the Egyptian Drug Authority (2019)
  2. Ministerial Decree No. 296 of 2009 — Medical devices regulation (2009)

ASH Editorial Notes

Egypt's traditional-medicine ecosystem (Tibb Nabawi / prophetic medicine) has cultural overlap with leech therapy via the hadith of al-Bukhari; legal practice remains regulated under modern biomedical pathways.

Related Jurisdictions

Israeli MoH — Israel

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.

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.

SAHPRA — South Africa

South Africa's SAHPRA (created 2018, replacing the Medicines Control Council) — leech therapy regulated as a medical device under the Medicines and Related Substances Act; traditional-health practitioners under separate THP Council.

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.

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This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.