Tanzania Medicines and Medical Devices Authority
TMDA · Tanzania · africa
Tanzania's Medicines and Medical Devices Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework or traditional-medicine pathways as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Tanzania
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.tmda.go.tz
Relevant Regulation Codes
- Tanzania Medicines and Medical Devices Act, Cap 219 (Revised Edition)
- Tanzania Traditional and Alternative Medicines Act, 2002
Prescriber Requirements
- Medical Council of Tanganyika–registered physician — order required for any biomedical device application
- Traditional and alternative medicine practitioners registered under the Traditional and Alternative Medicines Council may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
TMDA registration as applicable; English and Kiswahili-language labelling. Standard cold-chain conditions.
Import/Export Rules
TMDA import authorisation; Ministry of Livestock and Fisheries / veterinary services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes (NHIF) for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. TMDA is a WHO-listed Maturity Level 3 regulator for medicines (East African Community harmonisation); whether this maturity extends to live-organism medical devices has not been independently mapped by ASH.
Related Jurisdictions
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.
NAFDAC — Nigeria
Nigeria's national agency for food and drug administration and control — leech-specific regulatory pathway has not been independently verified by ASH.
DMP Morocco — Morocco
Morocco's Directorate of Medicines and Pharmacy under the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH.
FDA Ghana — Ghana
Ghana's Food and Drugs Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework or traditional medicine pathways as appropriate.