Saudi Food and Drug Authority
SFDA · Saudi Arabia · middle east
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- middle east
- Country
- Saudi Arabia
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.sfda.gov.sa
Relevant Regulation Codes
- Royal Decree No. M/6 of 1428H — SFDA establishment
- Medical Devices Interim Regulation, MDS-REQ 1 (2020 revision)
- Saudi MoH NCCAM (National Center for Complementary and Alternative Medicine) guidance
Prescriber Requirements
- Saudi Commission for Health Specialties (SCFHS)-registered MD
- Nurses (SCFHS-registered) under physician's order
- Hijama practitioners require separate NCCAM certification under MoH; leech therapy increasingly offered alongside Hijama in NCCAM-licensed clinics
Supply Chain & GMP
SFDA Medical Device Marketing Authorisation (MDMA); Saudi Authorised Representative required. Bilingual Arabic/English labelling.
Import/Export Rules
SFDA import licence + Ministry of Environment, Water and Agriculture (MEWA) clearance for live invertebrates. CITES via Saudi Wildlife Authority.
Reimbursement Context
Council of Cooperative Health Insurance (CCHI) governs the Cooperative Health Insurance Law — inpatient flap-salvage covered. NCCAM-licensed outpatient hirudotherapy / hijama services expanding under Vision 2030.
Key Regulatory Documents
ASH Editorial Notes
Saudi Arabia's prophetic-medicine framework (Tibb Nabawi) gives leech therapy a culturally embedded position; the 2014 NCCAM-KSA programme and Vision 2030 health-transformation pillar expand institutional support.
Related Jurisdictions
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.
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.
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.
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.