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Legislative Amendments

How Korean legislative amendments workโ€‹

In Korea, amendments to the Medical Devices Act and IVD Act:

  1. Drafted by MFDS or Ministry of Health and Welfare
  2. Published for public comment (typically 40 days)
  3. Reviewed by the National Assembly (for Act-level amendments) or Cabinet (for Decrees)
  4. Enacted with a specified commencement date (often 6โ€“12 months for major changes)

MFDS Notifications (๊ณ ์‹œ) โ€” administrative guidance documents โ€” can be amended faster than Acts or Decrees. MFDS can update a notification independently, typically requiring 20โ€“30 days notice before entry into force, without National Assembly or Cabinet review.

Where to track amendmentsโ€‹

  • law.go.kr โ€” track version history of Acts, Decrees, and Rules
  • MFDS website โ€” amendments to MFDS Notifications announced in news section