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MFDS IVD

IVD Medical Devices Act Enforcement Rule, Form 18 (amended 18 September 2026)

IVD product change application — Enforcement Rule Form 18, September 2026 amendment
South KoreaMinistry of Food and Drug SafetyRegistrationCurrentness under review
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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

IVD Medical Devices Act Enforcement Rule, Form 18 (amended 18 September 2026) is the official MFDS identifier for “IVD product change application — Enforcement Rule Form 18, September 2026 amendment”. IVD Medical Devices Act Enforcement Rule, Form 18 (amended 18 September 2026) is the official identifier MFDS uses for this instrument.

Instrument
IVD
Full name
IVD Medical Devices Act Enforcement Rule, Form 18 (amended 18 September 2026)
Category
Registration
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Source publication
Korean
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About this regulation

IVD product change application — Enforcement Rule Form 18, September 2026 amendment

Complete two-page official IVD change application form, marked amended 18 September 2026. Its front records application categories, printed processing periods, fee columns and procedural steps; its reverse contains administrative-disposition disclosure/acknowledgment for transfer. A blank application form does not establish that every legal-entity or reference-number change qualifies for this route. Source preservation does not certify blanket current legal effect or whole-country completeness.

IVD Medical Devices Act Enforcement Rule, Form 18 (amended 18 September 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.

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