UPDATE ON: MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS LISTING DATABASE

The Medical Devices Unit of the Botswana Medicines Regulatory Authority (BoMRA) would like to inform its valued stakeholders that the listing database of medical devices including In-Vitro Diagnostics (IVDs) devices has been published on the BoMRA website.

The listing database can be accessed on this link: https://bomra.co.bw/bomradownloads/#132-135-wpfd-medical-devices-register

Please use the link provided above to verify the information submitted to the Authority during the listing exercise project which was closed on the 31st March 2022. The stakeholders will be given up to 30th April 2023 to verify the information on the listing database and to engage the Authority should there be any queries.

Kindly note that the final database will be subject to regulatory processes such as vigilance reporting, post market surveillance, retention and import/export controls (permit and fees) with effect from 1st June 2023. Non listed medical devices including IVDs will continue to be imported through the exemption process also with effect from 1st June 2023.

If there are any further questions on this notice or any other issues related to this communication, please kindly contact the Botswana Medicines Regulatory Authority at: medicaldevices.services@bomra.co.bw