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BOMRA/ER/MED/P04/G03

Guideline for Labelling of Medical Devices including IVDs
BotswanaBotswana Medicines Regulatory AuthorityLabelingEffective 2022-04-01
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What this code is

BOMRA/ER/MED/P04/G03 is the official BoMRA identifier for “Guideline for Labelling of Medical Devices including IVDs”. BOMRA/ER/MED/P04/G03 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/ER/MED/P04/G03
Category
Labeling
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Authority source
English
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Dates
Published
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Effective
2022-04-01
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About this regulation

Guideline for Labelling of Medical Devices including IVDs

Issue 1.0, effective 1 April 2022. The labelling requirement for devices and IVDs: the label contents, the language requirement, the symbols and the instructions-for-use contents, with the IVD-specific additions. It is the reference BoMRA applies when it screens the mock-up label submitted with a registration application.

BOMRA/ER/MED/P04/G03 is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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