American Society of Hirudotherapy

Autorité Ivoirienne de Régulation des Produits de Santé

AIRP-CI · Côte d'Ivoire · africa

Regulatory jurisdiction profileJurisdictional reference
Unregulatednational regulator

Côte d'Ivoire's Ivorian Health Products Regulatory Authority — 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.

Regulatory Profile

Agency type
national regulator
Region
africa
Country
Côte d'Ivoire
Leech status
unregulated
Last ASH review
2026-05-27

Relevant Regulation Codes

  • Ivorian Loi n° 2015-533 du 20 juillet 2015 relative à l'exercice de la pharmacie
  • Ivorian national medical device regulatory framework
  • WAEMU / UEMOA and ECOWAS harmonised pharmaceutical frameworks where applicable
  • African Medicines Agency (AMA) harmonised frameworks (where applicable)

Prescriber Requirements

  • Ordre national des Médecins de Côte d'Ivoire–registered physician — order required for any biomedical device application
  • Allied health professional application under physician supervision per institutional protocol

Supply Chain & GMP

AIRP-CI registration as applicable; French-language labelling required by national law. Standard cold-chain conditions, with logistical constraints typical of West African coastal distribution.

Import/Export Rules

AIRP-CI and Direction des Services Vétérinaires clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.

Reimbursement Context

Couverture Maladie Universelle (CMU) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.

ASH Editorial Notes

Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. West African regulatory frameworks are progressively coordinating through UEMOA / ECOWAS and the African Medicines Agency (AMA); whether this captures live-organism medical devices has not been independently mapped by ASH.

Related Jurisdictions

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.