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MFDS 의료기기법

의료기기법 시행규칙 [별지 제30호서식]

Medical-device product change approval application — Enforcement Rule Form 30
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

의료기기법 시행규칙 [별지 제30호서식] is the official MFDS identifier for “Medical-device product change approval application — Enforcement Rule Form 30”. 의료기기법 시행규칙 [별지 제30호서식] is the official identifier MFDS uses for this instrument.

Instrument
의료기기법
Full name
의료기기법 시행규칙 [별지 제30호서식]
Category
Registration
Source links
Source publication
Korean
Linked source text; confirm the publisher, publication details and any later amendment or consolidated version.
Readable HTML
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

Medical-device product change approval application — Enforcement Rule Form 30

Complete two-page official product change approval form, marked amended 1 April 2025. Preserves the printed processing categories, conditional supporting evidence, electronic versus visit/post fees and reverse-side transferor sanctions disclosure/transferee acknowledgement. The form is distinct from business-licence, certification and notification routes. Original full-page images govern; native text is an explicitly incomplete search layer. Source preservation does not establish current legal effect or whole-country completeness.

의료기기법 시행규칙 [별지 제30호서식] is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.