ARCSA ARCSA-DE-004-2017-CFMRARCSA-DE-004-2017-CFMR
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
ARCSA-DE-004-2017-CFMR is the official ARCSA identifier for “Device primary-package labeling amendment — complete ARCSA instrument within original Gazette964”. ARCSA-DE-004-2017-CFMR is the official identifier ARCSA uses for this instrument.
- Instrument
- ARCSA-DE-004-2017-CFMR
- Full name
- ARCSA-DE-004-2017-CFMR
- Category
- Labeling
- Source publication
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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.
Device primary-package labeling amendment — complete ARCSA instrument within original Gazette964
Complete original ARCSA-DE-004-2017-CFMR amendment on physical and printed pages26–28 of the 48-page Registro Oficial No.964 of16March2017. The ARCSA instrument begins on page26 right column and closes on page28 right column before the separate BCE decision. Complete full-page source images retain adjacent INEN/BCE publication context, which is not a medical-device rule. Raw wholeGazette48pages retained. This historical amendment concerns primary-package labeling under the026/2016framework and is not a current consolidated law or a universal IVD-label rule. No source-only archiving claim promotes currentness, fees, clocks or completed questions.
ARCSA-DE-004-2017-CFMR is the official identifier ARCSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.