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BOMRA/ER/MED/P04/G09

Guideline for Application for Registration of IVD Medical Devices
BotswanaBotswana Medicines Regulatory AuthorityRegistrationEffective 2024-12-09
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What this code is

BOMRA/ER/MED/P04/G09 is the official BoMRA identifier for “Guideline for Application for Registration of IVD Medical Devices”. BOMRA/ER/MED/P04/G09 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/ER/MED/P04/G09
Category
Registration
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English
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Dates
Published
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Effective
2024-12-09
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About this regulation

Guideline for Application for Registration of IVD Medical Devices

Issue 1.0, effective 9 December 2024. The IVD counterpart to BOMRA/ER/MED/P04/G01 and a separate controlled document with its own number, not a re-publication of it: the two share the BoMRA template and therefore overlap heavily in wording, but each carries its own Document No, issue number, effective date and IVD-specific requirements (analytical performance, self-testing, companion diagnostics). Four annexes with it.

BOMRA/ER/MED/P04/G09 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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