BOMRA Medical Device Regulatory Strategy (2022–2030) Advancing Botswana from WHO GMRF “Basic Level of Control” to “Expanded Level” of Control
1.Strategic & Legislative Evolution
Botswana is transitioning from a basic oversight model to a comprehensive, globally aligned lifecycle regulatory
framework.
| Strategy Phase | Legal Framework | GMRF Level | Strategic Focus |
|---|---|---|---|
| 2022–2025 | MRSA 2013 | Basic | Legal provisions, guidelines, processes, listing of devices & MD Establishments, classification and foundational market entry rules. |
| 2026–2030 | MRSA 2025 | Expanded | Comprehensive Regulation: Mandatory registration, Licensing, inspections, retentions, active surveillance, and technical verification. |
2. Global Harmonization & Convergence
BoMRA ensures patient safety and trade facilitation through official membership in global regulatory forums:
- IMDRF: Affiliate Member (Joined September 2024).
- GHWP: Full Member (Endorsed December 2024).
3. Mandatory Registration & Variations Roadmap
Registration deadlines are based on risk class. Once a deadline passes, the device is removed from the Listing
Register and must be in the Registration Register.
| Device Risk Class | Registration Start | Mandatory Deadline | Registration Status |
|---|---|---|---|
| Class C & D (High) | April 2024 | June 30, 2026 | Active (Closing Soon) |
| Class B (Moderate) | April 1, 2026 | March 31, 2027 | Scheduled |
| Class A (Low/Notification) | October 1, 2026 | September 30, 2027 | Scheduled |
| Variations | April 2025 | Ongoing | In Effect |
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