BoMRA BOMRABOMRA/ER/MED/P04/G01
BOMRA/ER/MED/P04/G01 is the official BoMRA identifier for “Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics”. BOMRA/ER/MED/P04/G01 is the official identifier BoMRA uses for this instrument.
- Instrument
- BOMRA
- Full name
- BOMRA/ER/MED/P04/G01
- Category
- Registration
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- —
- Effective
- 2024-12-09
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Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics
Issue 3.0 of BoMRA's device registration guideline, effective 9 December 2024, and the lead instrument for Botswana device registration. It sets out who may apply (a local applicant acting for the product owner), the class-dependent evidence requirements for classes B, C and D, the dossier contents, screening and query-response timelines, and the marketing history and safety declarations the applicant must sign. Four annexes are ingested with it: the application-form templates, the safety declaration, the declaration of conformity and the marketing history declaration. Read together with the IVD guideline (`botswana-bomra-g-reg-ivd`), which is the same procedure for in vitro diagnostics.
BOMRA/ER/MED/P04/G01 is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.