Skip to main content

What is a Medical Device?

Under Korea's Medical Devices Act (μ˜λ£ŒκΈ°κΈ°λ²•), a medical device is any instrument, machine, apparatus, material, software, or other article intended by the manufacturer for use in humans for diagnosing, curing, treating, alleviating, or preventing disease or disability, or for investigating, replacing, or modifying anatomical structure or physiological function.

Key points​

  • Intended use determines classification, not the product alone
  • Software can be a medical device (SaMD) if it meets the intended use criteria
  • Accessories to medical devices are regulated as medical devices in their own right
  • IVD devices are excluded and regulated under the separate IVD Act

Relevant legislation​

  • Medical Devices Act, Article 2 (Definitions)
  • MFDS Notification β€” Medical Device Classification and Grade Assignment