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MFDS Notice No. 2026-6 (26 January 2026)

Regulations on Medical Device Approval, Notification and Review — 2026-6 consolidated base
South KoreaMinistry of Food and Drug SafetyRegistrationCurrentness under review
Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

MFDS Notice No. 2026-6 (26 January 2026) is the official MFDS identifier for “Regulations on Medical Device Approval, Notification and Review — 2026-6 consolidated base”. MFDS Notice No. 2026-6 (26 January 2026) is the official identifier MFDS uses for this instrument.

Instrument
MFDS
Full name
MFDS Notice No. 2026-6 (26 January 2026)
Category
Registration
Source links
Source publication
Korean
Linked source text; confirm the publisher, publication details and any later amendment or consolidated version.
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1 language version
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Dates
Published
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Effective
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Regulations on Medical Device Approval, Notification and Review — 2026-6 consolidated base

Complete 308-page consolidated medical-device regulation with annexes and forms through Notice No. 2026-6 dated 26 January 2026. The separate Notice No. 2026-34 amendment must be read with this base. Ordinary-device and IVD rules remain separate. Native glyph ordering fragments some Korean words; full original page figures preserve the actual text, table geometry and flowchart branches and govern quotation. Source preservation does not certify blanket current legal effect or whole-country completeness.

MFDS Notice No. 2026-6 (26 January 2026) is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.