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Who Needs to Comply?

Manufacturers (μ œμ‘°μ—…μž)​

Must hold: manufacturer licence (μ œμ‘°μ—… ν—ˆκ°€), KGMP certification, ν’ˆλͺ©ν—ˆκ°€/μ‹ κ³  per product, UDI-K/KIMS registration.

Foreign Manufacturers​

Do not need a Korean manufacturer licence but must:

  • Appoint a Korean agent (ν•œκ΅­ λŒ€λ¦¬μΈ) β€” typically the Korean importer
  • Obtain a Foreign GMP Certificate (ν•΄μ™Έμ œμ‘°μ†Œ 인증) recognised by MFDS

Importers (μˆ˜μž…μ—…μž)​

Must hold: importer licence (μˆ˜μž…μ—… ν—ˆκ°€), ν’ˆλͺ©ν—ˆκ°€/μ‹ κ³  for each imported product, ensure valid foreign GMP certificate, apply Korean-language labels.

Distributors & Retail Dealers​

Must register with MFDS before distributing. Must store devices properly and report adverse events.

Repair Business Operators​

Must register as a repair business (μˆ˜λ¦¬μ—…).