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ZAMRA ZAMRA

ZAMRA/MA/GUD/0005

Guidelines for Label and Instructions for Use for Medical Devices
ZambiaZambia Medicines Regulatory AuthorityLabeling
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What this code is

ZAMRA/MA/GUD/0005 is the official ZAMRA identifier for “Guidelines for Label and Instructions for Use for Medical Devices”. ZAMRA/MA/GUD/0005 is the official identifier ZAMRA uses for this instrument.

Instrument
ZAMRA
Full name
ZAMRA/MA/GUD/0005
Category
Labeling
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English
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14 articles · 1 language version
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English full text14 articles · English — ZAMRA official textRead HTML →
About this regulation

Guidelines for Label and Instructions for Use for Medical Devices

ZAMRA/MA/GUD/0005, the labelling guideline, setting the label and instructions-for-use content separately for devices other than IVDs and for IVDs. It adapts the GHTF labelling document: the running footer carries "September 16th, 2011", the date of the GHTF source rather than of the ZAMRA document, and the copy states no ZAMRA implementation date. A reference to the consolidated ZAMRA labelling requirements is what a Zambian registration submission is screened against.

ZAMRA/MA/GUD/0005 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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