Medical Society of Papua New Guinea / National Department of Health — Medicines and Cosmetics Branch
PNG NDoH-MC · Papua New Guinea · oceania
Papua New Guinea's National Department of Health, Medicines and Cosmetics Branch — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- oceania
- Country
- Papua New Guinea
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.health.gov.pg
Relevant Regulation Codes
- Papua New Guinea Medicines and Cosmetics Act (Chapter 219, Consolidated Laws)
- Papua New Guinea national medical device regulatory framework
Prescriber Requirements
- Medical Board of Papua New Guinea–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
National Department of Health registration as applicable; English-language labelling (with Tok Pisin and Hiri Motu at point of dispensing as appropriate). Standard cold-chain conditions, with logistical constraints typical of geographically dispersed Melanesian distribution.
Import/Export Rules
National Department of Health and National Agriculture Quarantine and Inspection Authority clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes 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. Pacific island regulatory frameworks often rely on regional harmonisation with Australia (TGA) and New Zealand (Medsafe); the exact mechanism for live-organism medical devices has not been independently mapped by ASH.
Related Jurisdictions
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.
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.
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.
Samoa MoH — Samoa
Samoa's Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate, with practical reliance on PIC-cooperating reference jurisdictions.