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BOMRA/ER/MED/P04/G04

Guideline for Essential Principles Applicable to Medical Devices
BotswanaBotswana Medicines Regulatory AuthorityGeneralEffective 2023-04-01
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BOMRA/ER/MED/P04/G04 is the official BoMRA identifier for “Guideline for Essential Principles Applicable to Medical Devices”. BOMRA/ER/MED/P04/G04 is the official identifier BoMRA uses for this instrument.

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BOMRA
Full name
BOMRA/ER/MED/P04/G04
Category
General
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Dates
Published
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Effective
2023-04-01
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About this regulation

Guideline for Essential Principles Applicable to Medical Devices

Issue 1.0, effective 1 April 2023. The safety and performance principles a device must satisfy, set out in the IMDRF/GHTF essential-principles structure: general principles applicable to all devices, then the principles specific to devices other than IVDs and the principles specific to IVDs. It is the substantive standard against which a Botswana registration is assessed, and the source of the essential principles Schedule in the draft 2026 Regulations.

BOMRA/ER/MED/P04/G04 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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