Smart Library

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

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

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.

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

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

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

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

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

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

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.

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'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.

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

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

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'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.

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'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.

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

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

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'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'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.

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.

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'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.

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

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

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'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'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.

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

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

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

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

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

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