MFDS MFDSMFDS Notice No. 2026-58 (10 August 2026)
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MFDS Notice No. 2026-58 (10 August 2026) is the official MFDS identifier for “Regulations on IVD Approval, Notification and Review — 2026-58 consolidated text”. MFDS Notice No. 2026-58 (10 August 2026) is the official identifier MFDS uses for this instrument.
- Instrument
- MFDS
- Full name
- MFDS Notice No. 2026-58 (10 August 2026)
- Category
- Registration
- Source publication
- Korean
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
Open a language version
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.
Regulations on IVD Approval, Notification and Review — 2026-58 consolidated text
Complete 114-page official IVD regulation with annexes and forms through Notice No. 2026-58 dated 10 August 2026. It includes IVD change procedures, minor-change reporting conditions and the original change-decision flowcharts. Ordinary-device rules do not substitute for this IVD instrument. Native text contains some glyph-order artifacts and omits embedded diagram wording; original full-page figures govern quotation and decision-branch interpretation. Source preservation does not certify blanket current legal effect or whole-country completeness.
MFDS Notice No. 2026-58 (10 August 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.