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The medicinal leech occupies an unusual regulatory position: a living animal that, in major markets, is regulated as a medical device.

A device that is alive

In the United States, the FDA cleared the medicinal leech as a medical device in 2004 — a landmark that formalised its clinical use. Other markets apply their own device or biological-product frameworks, and the exact classification varies by jurisdiction.

Layered obligations

• Medical-device or biological-product regulation at the destination
• CITES Appendix II export controls on the species
• Veterinary / animal-health requirements for live import

Why it matters for importers

Because obligations stack, the practical question is rarely “is it legal?” but “what documentation makes it legal here?” Clarify the destination market early so the paperwork is right the first time.