South African Health Products Regulatory Authority
SAHPRA · South Africa · 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.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- South Africa
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.sahpra.org.za
Relevant Regulation Codes
- Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended by Act 14 of 2015 (which created SAHPRA)
- Traditional Health Practitioners Act, 2007 (Act 22 of 2007)
- Medical Devices and IVDs Regulations, 2017
Prescriber Requirements
- HPCSA (Health Professions Council of South Africa)-registered MD
- SANC (South African Nursing Council)-registered nurse under physician's order
- Traditional Health Practitioners Council registrants have separate scope, but leech therapy primarily delivered in biomedical clinical settings
Supply Chain & GMP
SAHPRA medical-device licensing per 2017 regulations; English-language IFU.
Import/Export Rules
SAHPRA import licence + Department of Agriculture, Land Reform and Rural Development clearance for live invertebrates. CITES via Department of Forestry, Fisheries and the Environment.
Reimbursement Context
National Health Insurance Act, 2023 implementation pending; private medical schemes (Discovery, Bonitas, GEMS) cover inpatient flap-salvage indications. Outpatient coverage rare.
Key Regulatory Documents
ASH Editorial Notes
SAHPRA replaced the older MCC in February 2018. South Africa's parallel statutory framework for traditional health practitioners is unusual in Africa; leech therapy in clinical practice remains biomedical-led.
Related Jurisdictions
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.
WHO — Global (United Nations specialised agency)
Global health authority — Hirudo medicinalis listed in the WHO Monographs on Selected Medicinal Plants (informational) and embedded in the Traditional Medicine Strategy 2014–2023 and 2025–2034 successor.
NAFDAC — Nigeria
Nigeria's national agency for food and drug administration and control — leech-specific regulatory pathway has not been independently verified by ASH.