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BOMRA/ER/MED/P04/G05

Guideline for Medical Devices Classification
BotswanaBotswana Medicines Regulatory AuthorityClassificationEffective 2023-04-01
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What this code is

BOMRA/ER/MED/P04/G05 is the official BoMRA identifier for “Guideline for Medical Devices Classification”. BOMRA/ER/MED/P04/G05 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/ER/MED/P04/G05
Category
Classification
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Dates
Published
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Effective
2023-04-01
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About this regulation

Guideline for Medical Devices Classification

BoMRA's device classification guideline, Issue 1.0, effective 1 April 2023. It establishes the four-class system (A, B, C, D), the manufacturer's duty to classify, and the nineteen classification rules with the illustrative examples BoMRA adopts, keyed to the GHTF/IMDRF rule set. Each rule is ingested as its own `rule` block so a single rule can be cited on its own.

BOMRA/ER/MED/P04/G05 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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