Jurisdiktionen

United States

First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).

Canada

Regulates Hirudo medicinalis under the Medical Devices Regulations as a Class II device; mirrors FDA risk classification with bilingual labelling requirements.

Mexico

Mexico's federal health-risk authority — leech therapy regulated as a medical device under General Health Law, with traditional-medicine carve-outs at state level.

European Union

Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.

European Union

EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.

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).

Germany

Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.

France

Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.

Italy

Italian Medicines Agency — leech therapy supervised under MDR via the Ministero della Salute, with established complementary-medicine reimbursement in selected regions (Toscana, Emilia-Romagna).

Spain

Spanish medicines and devices agency — leech therapy regulated as a medical device with mandatory Spanish-language IFU and autonomous-community-level integration in some public health services.

Switzerland

Switzerland's therapeutic-products regulator — applies MepV (Medical Devices Ordinance) closely harmonised with EU MDR, with bilateral recognition agreements covering CE-marked devices including leeches.

Sweden

Sweden's medical products agency — regulates leeches via the EU MDR and Patientsäkerhetslagen, with reimbursement limited to inpatient reconstructive indications under regional landsting protocols.

Finland

Finland's medicines agency — regulates medical devices including leeches under EU MDR; oversight transferred from Valvira to Fimea for medical devices effective 1 January 2020.

Switzerland

Swiss federal public-health authority — sets reimbursement scope under KLV including the historic 2017 decision to make hirudotherapy permanently reimbursable when delivered by FMH-credentialed physicians.

Russia

Russia's federal healthcare regulator — uniquely classifies medicinal leeches as a pharmaceutical drug under Federal Law No. 61-FZ, with a federally recognised hirudotherapy speciality and OMS coverage.

Global (United Nations specialised agency)

Global health authority — Hirudo medicinalis listed in the WHO Monographs on Selected Medicinal Plants (informational) and embedded in the Traditional Medicine Strategy 2014–2023 and 2025–2034 successor.

Austria

Austria's federal authority for safety in health care — applies EU MDR directly; leech-specific regulation has not been independently verified by ASH and is presumed to follow the general EU medical-device framework.

Netherlands

Dutch Medicines Evaluation Board — paired with IGJ (Health and Youth Care Inspectorate) for device oversight; leech-specific regulatory pathway in the Netherlands has not been independently verified by ASH.

Denmark

Denmark's medicines agency — applies EU MDR for medical devices; leech-specific regulation has not been independently verified by ASH and is presumed to follow the general MDR framework.

Norway

Norway's medical products agency (formerly Statens legemiddelverk, rebranded DMP in 2024) — applies EU MDR via EEA Agreement; leech-specific regulation has not been independently verified by ASH.

Portugal

Portugal's national medicines and health products authority — applies EU MDR for medical devices; leech-specific regulation has not been independently verified by ASH.

Belgium

Belgium's federal agency for medicines and health products — applies EU MDR for devices; leech-specific regulation has not been independently verified by ASH.

Poland

Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products — applies EU MDR; leech-specific regulation has not been independently verified by ASH.

Croatia

Croatia's agency for medicinal products and medical devices — applies EU MDR; leech-specific regulation has not been independently verified by ASH.

Greece

Greek national medicines agency under the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general EU MDR framework as appropriate.

Hungary

Hungary's National Institute of Pharmacy and Nutrition — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general EU MDR framework as appropriate.

Romania

Romania's National Agency of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general EU MDR framework as appropriate.

Iceland

Iceland's Medicines Agency — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the EEA-aligned medical device framework as appropriate.

Belarus

Belarus's Republican Center for Examinations and Tests in Health Service (Ministry of Health) — under Belarusian law leeches have been used historically in clinical and traditional practice; the exact contemporary regulatory pathway has not been independently verified by ASH.

Estonia

Estonia's State Agency of Medicines — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Estonian national law; leech-specific national authorisation has not been independently verified by ASH.

Lithuania

Lithuania's State Medicines Control Agency — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Lithuanian national law; leech-specific national authorisation has not been independently verified by ASH.

Slovakia

Slovakia's State Institute for Drug Control — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Slovak national law; leech-specific national authorisation has not been independently verified by ASH.

Serbia

Serbia's Medicines and Medical Devices Agency — 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.

Latvia

Latvia's State Agency of Medicines — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Latvian national law; leech-specific national authorisation has not been independently verified by ASH.

Ireland

Ireland's Health Products Regulatory Authority — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Irish national law; leech-specific national authorisation has not been independently verified by ASH.

Czech Republic

Czech Republic's State Institute for Drug Control — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Czech national law; leech-specific national authorisation has not been independently verified by ASH.

Slovenia

Slovenia's Agency for Medicinal Products and Medical Devices — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Slovenian national law; leech-specific national authorisation has not been independently verified by ASH.

Bulgaria

Bulgaria's Bulgarian Drug Agency — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Bulgarian national law; leech-specific national authorisation has not been independently verified by ASH.

Malta

Malta's Medicines Authority — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Maltese national law; leech-specific national authorisation has not been independently verified by ASH.

Cyprus

Cyprus's Pharmaceutical Services (Ministry of Health) — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Cypriot national law; leech-specific national authorisation has not been independently verified by ASH.

Luxembourg

Luxembourg's Direction de la santé (Division of Pharmacy and Medicines) — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Luxembourgish national law; leech-specific national authorisation has not been independently verified by ASH.

Turkey

Turkey's Medicines and Medical Devices Agency — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented historical clinical and traditional-medical role in the Ottoman and modern Turkish medical traditions, with contemporary recognition under traditional and complementary medicine pathways.

Ukraine

Ukraine's State Expert Center of the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented clinical role in the continuous Russian-Ukrainian hirudotherapy tradition, with contemporary status under the Ukrainian biomedical framework.

Moldova

Moldova's Agency of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have a documented role in the continuous Russian-Romanian regional hirudotherapy tradition, with contemporary status under the Moldovan biomedical framework.

Georgia

Georgia's Regulation Agency for Medical and Pharmaceutical Activities (Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs) — 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.

Armenia

Armenia's Scientific Centre of Drug and Medical Technology Expertise (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.

Albania

Albania's National Agency of Medicines and Medical Devices — 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.

North Macedonia

North Macedonia's Agency for Medicinal Products and Medical Devices — 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.

Bosnia and Herzegovina

Bosnia and Herzegovina's Agency for Medicinal Products and Medical Devices — 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.

Montenegro

Montenegro's Agency for Medicinal Products and Medical Devices — 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.

Kosovo

Kosovo's Medicines Agency — 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.

Liechtenstein

Liechtenstein's Office of Public Health — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under harmonised Swiss / EEA pharmaceutical and medical device frameworks as appropriate.

San Marino

San Marino's Health Authority (Istituto per la Sicurezza Sociale) — 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 significant reliance on Italian / EU authorisations.

Andorra

Andorra'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 Spanish AEMPS and French ANSM authorisations.

Japan

Japan's medicines and devices regulator — leech therapy classified within the Kampo / traditional-medicine framework under MHLW oversight, with no PMDA-issued device approval to date.

China

China's medical-products regulator — leeches (水蛭 / shui zhi) are codified in the Chinese Pharmacopoeia as Traditional Chinese Medicine (TCM) and regulated as a Chinese herbal medicine.

South Korea

South Korea's drug-safety regulator (formerly KFDA) — leech therapy practised within the Korean Medicine (한의학 / Hanui) tradition; Hirudo medicinalis listed in the Korean Pharmacopoeia.

India

India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.

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.

Taiwan

Taiwan's food and drug administration — leech preparations regulated under the Pharmaceutical Affairs Act with traditional Chinese medicine practice formally licensed under the Ministry of Health and Welfare.

Philippines

Philippine FDA (under Department of Health) — leech therapy regulated as a medical device with parallel traditional and alternative medicine pathway under the PITAHC framework.

Vietnam

Vietnam's Ministry of Health medical-device and pharmaceutical authorities — leech-specific regulation has not been independently verified by ASH and may fall under traditional-medicine carve-outs.

Thailand

Thailand's FDA under the Ministry of Public Health — leech-specific regulatory status has not been independently verified by ASH; Thai traditional medicine has separate statutory framework under the DTAM.

Indonesia

Indonesia's national agency for drug and food control — leech-specific regulatory pathway has not been independently verified by ASH; pengobatan tradisional has a separate framework under the Ministry of Health.

Pakistan

Pakistan's Drug Regulatory Authority — federal authority over therapeutic goods; leech-specific regulatory pathway has not been independently verified by ASH.

Malaysia

Malaysia's National Pharmaceutical Regulatory Agency (under the Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general medical device framework or traditional and complementary medicine pathways as appropriate.

Bangladesh

Bangladesh's Directorate General of Drug Administration (under the Ministry of Health and Family Welfare) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general medical device framework or traditional medicine pathways as appropriate.

Sri Lanka

Sri Lanka's National Medicines Regulatory Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general medical device framework or indigenous medicine (Ayurveda) pathways as appropriate.

Kazakhstan

Kazakhstan's National Centre for Expertise of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.

Mongolia

Mongolia's Medicines Regulatory Authority (under the Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under traditional Mongolian medicine alongside the contemporary biomedical framework.

Nepal

Nepal's Department of Drug Administration (Ministry of Health and Population) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under Ayurveda alongside the contemporary biomedical framework.

Uzbekistan

Uzbekistan's Agency for Development of the Pharmaceutical Industry (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.

Kyrgyzstan

Kyrgyzstan's Department of Medicines and Medical Devices (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.

Cambodia

Cambodia's Department of Drugs, Food, Medical Devices and Cosmetics (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.

Laos

Laos' Food and Drug Department (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.

Myanmar

Myanmar's Food and Drug Administration (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.

Brunei Darussalam

Brunei's Pharmaceutical Services Department (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.

Bhutan

Bhutan's national drug regulator — leech-specific authorisation pathway not independently verified by ASH.

Maldives

Maldives' national food / drug authority — leech-specific authorisation pathway not independently verified by ASH.

Brazil

Brazil's national health-surveillance agency — leech therapy regulated as a medical device with parallel coverage under the SUS Practices Integrativas e Complementares (PICS) policy.

Colombia

Colombia's national medicines and devices surveillance agency — leech therapy regulated as a medical device under Decreto 4725/2005 with TM/CAM oversight by the Ministerio de Salud.

Peru

Peru's medicines, supplies and drugs directorate — leech therapy supervised under Ley General de Salud and complementary-medicine framework, with DIRESA-level enforcement.

Argentina

Argentina's national administration of drugs, food and medical technology — leech-specific regulatory pathway has not been independently verified by ASH.

Chile

Chile's Public Health Institute — national reference authority for medicines and medical devices; leech-specific regulatory pathway has not been independently verified by ASH.

Ecuador

Ecuador's national agency for sanitary regulation, control and surveillance — leech-specific regulatory pathway has not been independently verified by ASH.

Cuba

Cuba's Centre for State Control of Medicines and Medical Devices — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework or traditional and natural medicine pathways as appropriate.

Costa Rica

Costa Rica's Ministry of Health drug and device registry — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.

Jamaica

Jamaica's Pharmacy Council (statutory regulator of pharmacy practice, in coordination with the Ministry of Health and Wellness) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.

Trinidad and Tobago

Trinidad and Tobago's Drug Inspectorate (Chemistry, Food and Drugs Division, Ministry of Health) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national medical device framework as appropriate.

Venezuela

Venezuela's Instituto Nacional de Higiene Rafael Rangel (Ministerio del Poder Popular para la Salud) — 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.

Uruguay

Uruguay's Ministry of Public Health, Department of Medical Technology — 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.

Bolivia

Bolivia's Agencia Estatal de Medicamentos y Tecnologías en Salud (Ministerio de Salud y Deportes) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under Andean traditional medicine alongside the contemporary biomedical framework.

Panama

Panama's National Directorate of Pharmacy and Drugs (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.

Dominican Republic

Dominican Republic's Directorate General of Medicines, Food and Health Products (Ministerio de Salud Pública) — 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.

Paraguay

Paraguay's National Directorate of Health Surveillance (Ministry of Public 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.

Guatemala

Guatemala's Department of Regulation and Control of Pharmaceutical Products and Related Items — 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.

Honduras

Honduras' Health Regulatory Agency — 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.

El Salvador

El Salvador's National Directorate of Medicines — 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.

Guyana

Guyana's national food / drugs department — leech-specific authorisation pathway not independently verified by ASH.

Suriname

Suriname's national pharmaceutical bureau — leech-specific authorisation pathway not independently verified by ASH.

Belize

Belize's medicines quality control unit — leech-specific authorisation pathway not independently verified by ASH.

Haiti

Haiti's pharmacy / medicine / traditional medicine directorate — leech-specific authorisation pathway not independently verified by ASH.

Israel

Israel's Ministry of Health (Misrad HaBri'ut) — leech therapy regulated under the Pharmacists' Ordinance with Medical Devices Division oversight; significant clinical use in reconstructive and microsurgery services.

Egypt

Egypt's Egyptian Drug Authority (formed 2019, replacing the older CAPA / Central Administration of Pharmaceutical Affairs) — leech therapy regulated as a medical device with parallel traditional-medicine context.

Saudi Arabia

Saudi Arabia's SFDA — leech therapy supervised under medical-device pathway, with Saudi Vision 2030 expansion of traditional/complementary medicine via NCCAM-KSA at the Ministry of Health.

United Arab Emirates

UAE Ministry of Health and Prevention — federal authority over health products; leech-specific regulation has not been independently verified by ASH.

Lebanon

Lebanon's Ministry of Public Health Pharmacy Department — 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.

Jordan

Jordan's Food and Drug Administration — 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.

Iran

Iran's Food and Drug Administration (under the Ministry of Health and Medical Education) — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches have historical recognition under traditional Persian medicine (Tibb-e-Sonnati) pathways alongside the contemporary biomedical framework.

Iraq

Iraq's KIMADIA (State Company for Marketing Drugs and Medical Appliances) — the principal national entity for procurement, registration and oversight of medicines and medical devices; leech-specific regulatory pathway has not been independently verified by ASH.

Qatar

Qatar's Ministry of Public Health, Department of Pharmacy and Drug Control — 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.

Kuwait

Kuwait's Ministry of Health, Drug and Food Control Administration — 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.

Oman

Oman's Ministry of Health, Directorate General of Pharmaceutical Affairs and Drug Control — 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.

Bahrain

Bahrain's National Health 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.

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.

Nigeria

Nigeria's national agency for food and drug administration and control — leech-specific regulatory pathway has not been independently verified by ASH.

Morocco

Morocco's Directorate of Medicines and Pharmacy under the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH.

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.

Kenya

Kenya's Pharmacy and Poisons Board — 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.

Tunisia

Tunisia's Directorate of Pharmacy and Medicines (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 or traditional-medicine pathways as appropriate.

Algeria

Algeria's National Agency for Pharmaceutical Products — 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.

Ethiopia

Ethiopia's Food and Drug 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.

Tanzania

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.

Uganda

Uganda's National Drug 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.

Madagascar

Madagascar's Agence du Médicament — 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.

Senegal

Senegal's Directorate of Pharmacy and Medicines (Ministry of Health and Social Action) — 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.

Zimbabwe

Zimbabwe's Medicines Control 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.

Rwanda

Rwanda's Food and Drugs 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.

Mozambique

Mozambique's National Medicines 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.

Botswana

Botswana Medicines 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.

Namibia

Namibia's Medicines Regulatory Council — 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.

Côte d'Ivoire

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.

Mali

Mali's pharmacy / medicine directorate — leech-specific authorisation pathway not independently verified by ASH.

Burkina Faso

Burkina Faso's pharmacy / medicine directorate — leech-specific authorisation pathway not independently verified by ASH.

Mauritius

Mauritius pharmacy regulator — leech-specific authorisation pathway not independently verified by ASH.

Cape Verde

Cape Verde's pharmaceutical / food regulatory agency — leech-specific authorisation pathway not independently verified by ASH.

Djibouti

Djibouti's pharmacy / laboratory directorate — leech-specific authorisation pathway not independently verified by ASH.

Sierra Leone

Sierra Leone Pharmacy Board — leech-specific authorisation pathway not independently verified by ASH.

Liberia

Liberia LMHRA — leech-specific authorisation pathway not independently verified by ASH.

Gambia

Gambia's MCA — leech-specific authorisation pathway not independently verified by ASH.

Lesotho

Lesotho's MRA — leech-specific authorisation pathway not independently verified by ASH.

Eswatini

Eswatini's MRC — leech-specific authorisation pathway not independently verified by ASH.

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.

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

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.

Papua New Guinea

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.

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.

Tonga

Tonga'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.

Vanuatu

Vanuatu'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.

Solomon Islands

Solomon Islands' MHMS — leech-specific authorisation pathway not independently verified by ASH.

Kiribati

Kiribati's MHMS — leech-specific authorisation pathway not independently verified by ASH.

Tuvalu

Tuvalu's Ministry of Health — leech-specific authorisation pathway not independently verified by ASH.

Marshall Islands

Marshall Islands MoHHS — leech-specific authorisation pathway not independently verified by ASH.

Palau

Palau MHHS — leech-specific authorisation pathway not independently verified by ASH.

Micronesia (Federated States)

Federated States of Micronesia DHSA — leech-specific authorisation pathway not independently verified by ASH.