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BOMRA/ER/MED/P04/G06

Guideline for In Vitro Diagnostic (IVD) Medical Devices Classification
BotswanaBotswana Medicines Regulatory AuthorityClassificationEffective 2023-04-01
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What this code is

BOMRA/ER/MED/P04/G06 is the official BoMRA identifier for “Guideline for In Vitro Diagnostic (IVD) Medical Devices Classification”. BOMRA/ER/MED/P04/G06 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/ER/MED/P04/G06
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 In Vitro Diagnostic (IVD) Medical Devices Classification

Issue 1.0, effective 1 April 2023. The IVD classification guideline, a separate controlled document from the general classification guideline. It sets the four IVD classes and the seven IVD classification rules (each ingested as its own `rule` block), keyed to individual and public health risk as the IMDRF IVD classification guidance does.

BOMRA/ER/MED/P04/G06 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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