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PMDA MHLW

MHLW Ordinance No. 169

Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In-vitro Diagnostic Reagents
JapanMinistry of Health, Labour and WelfareGMP/QMS
What this code is

MHLW Ordinance No. 169 is the official MHLW identifier for “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In-vitro Diagnostic Reagents”. MHLW Ordinance No. 169 is the official identifier MHLW uses for this instrument.

Instrument
MHLW
Full name
MHLW Ordinance No. 169
Category
GMP/QMS
Source links
Authority source
Japanese
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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117 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
December 17, 2004
Effective
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Each version has stable article 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

Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In-vitro Diagnostic Reagents

Controlling Japanese QMS ordinance (Heisei 16 MHLW Ordinance No. 169), e-Gov lawdata 416M60000100169. The previous metadata URL was a PMDA portal, not the ordinance text. No government English translation was found on Japanese Law Translation for this ordinance.

MHLW Ordinance No. 169 is the official identifier MHLW uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.