MFDS 의료기기법의료기기법 시행규칙 [별지 제29호서식]
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
의료기기법 시행규칙 [별지 제29호서식] is the official MFDS identifier for “Medical-device manufacturing/import business change application — Enforcement Rule Form 29”. 의료기기법 시행규칙 [별지 제29호서식] is the official identifier MFDS uses for this instrument.
- Instrument
- 의료기기법
- Full name
- 의료기기법 시행규칙 [별지 제29호서식]
- Category
- Registration
- Source publication
- Korean
- Readable HTML
- 1 language version
- 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.
Medical-device manufacturing/import business change application — Enforcement Rule Form 29
Complete two-page official manufacturing/import business change form, marked amended 1 April 2025. Preserves the separate quality-manager branch, site/QMS evidence conditions, fee-table cross-reference, administrative-information consent and reverse-side sanctions disclosure. Business-licence changes are not a universal foreign-manufacturer product-change route. 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 제29호서식] is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.