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BOMRA/ER/MED/P04/G07

Guidance on Grouping of Medical Devices including IVDs
BotswanaBotswana Medicines Regulatory AuthorityRegistrationEffective 2024-12-09
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What this code is

BOMRA/ER/MED/P04/G07 is the official BoMRA identifier for “Guidance on Grouping of Medical Devices including IVDs”. BOMRA/ER/MED/P04/G07 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/ER/MED/P04/G07
Category
Registration
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Dates
Published
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Effective
2024-12-09
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About this regulation

Guidance on Grouping of Medical Devices including IVDs

Issue 3.0, effective 9 December 2024. Sets out when several devices may be covered by a single registration application (system, family, set, IVD cluster, kit) and the criteria each grouping must meet. Do not confuse this with the separate, non-batch BoMRA scan registered under BOMRA/ER/MD/P04/G07, "Reliance/Recognition on Information from Regional and International Bodies" — that is a different document with a near-identical number (ER/MED vs ER/MD); this row is the grouping guidance.

BOMRA/ER/MED/P04/G07 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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