MFDS 체외진단의료기기법체외진단의료기기법 시행규칙 [별지 제17호서식]
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
체외진단의료기기법 시행규칙 [별지 제17호서식] is the official MFDS identifier for “IVD manufacturing/import business change application — Enforcement Rule Form 17”. 체외진단의료기기법 시행규칙 [별지 제17호서식] is the official identifier MFDS uses for this instrument.
- Instrument
- 체외진단의료기기법
- Full name
- 체외진단의료기기법 시행규칙 [별지 제17호서식]
- Category
- Registration
- Source publication
- Korean
- Readable HTML
- 1 language version
- Published
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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.
IVD manufacturing/import business change application — Enforcement Rule Form 17
Complete two-page official IVD manufacturing/import business change form, marked amended 18 September 2026. Preserves conditional site, representative and quality-manager evidence, electronic and visit/post fee columns, administrative-information consent and transferor/transferee sanctions acknowledgement. These business-change branches do not establish a universal fee or route for changing a foreign product manufacturer. 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.
체외진단의료기기법 시행규칙 [별지 제17호서식] is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.