Therapeutic Goods Administration
TGA · Australia · oceania
Australia's therapeutic-goods regulator — medicinal leeches included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa medical device with import permit oversight.
Regulatory Profile
- Agency type
- national regulator
- Region
- oceania
- Country
- Australia
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.tga.gov.au
Relevant Regulation Codes
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Biosecurity Act 2015 (live-invertebrate import)
Prescriber Requirements
- Australian-registered medical practitioner prescription required; states/territories administer scope via AHPRA-registered professions
- RN application under standing order; specialist nurse practitioners with wound-care endorsement within scope
- Naturopaths are self-regulated post-2017 deregistration — leech therapy outside hospitals operates in unregulated grey zone
Supply Chain & GMP
ARTG entry mandatory; sponsor in Australia must hold equivalent of MDR Class IIa documentation. English-language IFU. Cold chain 4–10 °C.
Import/Export Rules
Biosecurity import permit from Department of Agriculture, Fisheries and Forestry (DAFF) required for live H. medicinalis. CITES Appendix II permit via Department of Climate Change, Energy, the Environment and Water (DCCEEW). Strict quarantine — Australia historically denied some leech imports on biosecurity grounds.
Reimbursement Context
Medicare Benefits Schedule (MBS) does not have a dedicated item for leech therapy; inpatient use covered via DRG (AR-DRG) bundling. Private health insurance variable.
Key Regulatory Documents
ASH Editorial Notes
Australia's strict biosecurity regime (Quarantine Act 1908, now Biosecurity Act 2015) historically created supply constraints; current practice imports periodically rather than maintaining domestic breeding stocks.
Related Jurisdictions
FDA — United States
First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).
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).
Medsafe — New Zealand
New Zealand's medicines and medical-devices regulator — operates under the Medicines Act 1981 with leech therapy regulated as a notified medical device and biosecurity-controlled import.
HSA — Singapore
Singapore's health sciences regulator — leech therapy supervised under the Health Products Act 2007 with separate licensing for TCM practitioners using leeches in clinical practice.