Pure Global AI
BoMRA BOMRA

BOMRA/PCT/PV/P10/G01

National Guidelines for Medical Device Adverse Event Reporting
BotswanaBotswana Medicines Regulatory AuthorityVigilanceEffective 2023-03-15
Official source linked
What this code is

BOMRA/PCT/PV/P10/G01 is the official BoMRA identifier for “National Guidelines for Medical Device Adverse Event Reporting”. BOMRA/PCT/PV/P10/G01 is the official identifier BoMRA uses for this instrument.

Instrument
BOMRA
Full name
BOMRA/PCT/PV/P10/G01
Category
Vigilance
Source links
Authority source
English
Open the issuing-authority text
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
0 articles · 1 language version
Read the full text →
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
—
Effective
2023-03-15
Readable full text

Open a language version

Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

English full text0 articles · English — BoMRA official textRead HTML →
About this regulation

National Guidelines for Medical Device Adverse Event Reporting

Issue 1.0, effective 15 March 2023. Botswana's device vigilance instrument: what a medical device adverse event is, who must report it and to whom, the reporting timelines keyed to severity, the information a report must carry, and the follow-up and signal-review loop. It reaches manufacturers, importers, distributors, health facilities and users, and it is a device-specific document rather than a medicines pharmacovigilance guideline with a device clause attached.

BOMRA/PCT/PV/P10/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.

Verified