Medical Device Regulatory Requirements in Botswana
| 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 |
| Registration Process |
Guideline for Registration of Medical devices
| Click Here
|
| Registration Timeline |
3 to 5 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
The product labelling must be in English |
| Database |
BRIMS
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
The Medicines Regulatory Authority ( |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025