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MFDS 체외진단의료기기법

체외진단의료기기법 시행규칙 [별표 3]

IVD Medical Devices Act Enforcement Rule Annex 3 — fees, September 2026 insertion
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

체외진단의료기기법 시행규칙 [별표 3] is the official MFDS identifier for “IVD Medical Devices Act Enforcement Rule Annex 3 — fees, September 2026 insertion”. 체외진단의료기기법 시행규칙 [별표 3] is the official identifier MFDS uses for this instrument.

Instrument
체외진단의료기기법
Full name
체외진단의료기기법 시행규칙 [별표 3]
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
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
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Effective
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Readable full text

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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

IVD Medical Devices Act Enforcement Rule Annex 3 — fees, September 2026 insertion

Complete one-page official IVD fee annex, marked newly inserted 18 September 2026. Preserves all initial/business/product-change/new-development and clinical-laboratory certification entries with separate electronic and visit/post KRW columns. Site, representative transfer/inheritance and quality-manager branches are not blanket fees for changing product names, models or foreign manufacturers. 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 [별표 3] is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.