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Pharmaceutical Affairs Act — Related Provisions

The Pharmaceutical Affairs Act (약사법) primarily governs pharmaceuticals in Korea but intersects with medical device regulation in several areas:

Intersection areas​

  • Combination products — when the primary mode of action is pharmacological, the product is regulated as a drug under this Act, with MFDS medical device input
  • Pharmacies and retail medical devices — distribution of certain lower-risk devices through pharmacies
  • Drug-device combination labelling — labelling must satisfy both Acts where both apply