| Regulatory Authority | Botswana Medicines Regulatory Authority (BoMRA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | A,B,C,D |
| Medical Device Regulations | Medical Device Guidelines (Same Regulations for IVD) | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | Guidlines |
| Device Classification Guidelines | Principles Medical Devices Classification | Click Here |
| Registration Process | Guideline for Registration of Medical devices | Click Here |
| Registration Timeline | 3 to 5 months |
| Technical Documentation Format |
Refer to Section 6 | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | The product labelling must be in English |
| Labeling Requirements |
“Guideline for Labelling of Medical Devices including IVDs BOMRA/ER/MED/P04/G03 | Click Here |
| Clinical Trials Information |
Guideline for Clinical Trial Application and Authorization in Botswana: | Click Here |
| Database | BRIMS | Click Here |
| Fees for Submission |
Regulatory Fees BoMRA | Click Here |
| Reportable Incidents |
Healthcare professionals, device users and other reporters besides MAH are encouraged to report adverse events/incidents related to medical devices irrespective of whether they are |
| Adverse Event Reporting Timelines | a) Serious public health threat events shall be reported to the Authority within 48 hours after first knowledge of the reaction by the manufacturer. |
| Advertising and Promotions |
Advertisement and Promotion of Medical Products | Click Here |
| Additional Information | The Medicines Regulatory Authority (“Authority”) is a corporate body established under Section 3 of the Medicines and Related Substances Act (“MRSA”) and referred to as the Botswana Medicines Regulatory Authority or BoMRA. |
| Contact Phone | +267 373 1720 / 318 6254 |
| Contact Email | nfo@bomra.co.bw |
| Contact Address | Plot 112, Gaborone International Finance Park Gaborone, Botswana |