Botswana medical device listing requirements: deadline 31 March

For companies trading in Botswana, please take note of the deadline and resources.

For listing purposes, it is not required to have a local agent and/or representative in Botswana. Any company exporting medical devices to Botswana must complete the stipulated listing process: (i) FORM 1: for medical devices for which you are a manufacturer/an authorised representative in Botswana; (ii) FORM 2 for medical devices that you just distribute in Botswana. Please note that the GMDN descriptor can be used for the “Intended Use”.

• BoMRA listing of medical devices
• Guideline for listing medical devices
• Form 1 for listing medical devices
• Form 2 for listing medical devices
• Annexure 1 of listing medical devices