Medsafe — Medicines and Medical Devices Safety Authority
Medsafe · New Zealand · oceania
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.
Regulatory Profile
- Agency type
- national regulator
- Region
- oceania
- Country
- New Zealand
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.medsafe.govt.nz
Relevant Regulation Codes
- Medicines Act 1981
- Medicines Regulations 1984
- Biosecurity Act 1993 (live invertebrate import)
- Therapeutic Products Act 2023 (forthcoming replacement framework — implementation in transition)
Prescriber Requirements
- Medical Council of New Zealand–registered MD prescription required
- RN application under standing order; rural practice with Nurse Practitioner scope expanded post-2021
- Rongoā Māori practitioners (traditional Māori healing) have separate Health Practitioners Competence Assurance Act scope but leech therapy not part of rongoā
Supply Chain & GMP
Web Assembly of Medical Devices (WAND) notification required for distributors. Cold chain 4–10 °C. English-language IFU.
Import/Export Rules
Ministry for Primary Industries (MPI) import permit for live invertebrates; CITES via Department of Conservation. Stringent biosecurity rivalling Australia's.
Reimbursement Context
PHARMAC does not list leech therapy; Te Whatu Ora (Health New Zealand) covers inpatient hospital use under bulk funding. Private insurance variable.
Key Regulatory Documents
- Medicines Act 1981 (1981)
- Therapeutic Products Act 2023 (2023)
ASH Editorial Notes
The Therapeutic Products Act 2023 is intended to replace the Medicines Act and modernise medical-device regulation; implementation phased through 2025–2027 with active transitional rules.
Related Jurisdictions
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).
TGA — Australia
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.
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.
Fiji PTS — Fiji
Fiji's Pharmacy and Therapeutics Section (under the Ministry of Health and Medical Services) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.