BoMRA – Medical Device Registration

Required for entities importing, manufacturing, or distributing medical devices in Botswana.

Prerequisites

• Company or business must be registered in Botswana.
• Directors / principals fit-and-proper test requirements met.
• Adequate capital and infrastructure per regulator thresholds.

Required Documents

• Certificate of Incorporation and CIPA Form 2.
• Certified copies of Omang / Passports for directors and shareholders.
• CVs and fit-and-proper declarations for key management.
• Business plan and financial projections (3-5 years).
• Proof of physical business premises (lease or title deed).
• Tax clearance certificate from BURS.

Engagement Process

1. Submit enquiry with preliminary information via the product form.
2. Receive engagement letter and fee proforma from The Secretary.
3. Provide required documents and complete KYC where applicable.
4. We prepare, file, and follow through with the regulator on your behalf.
5. Delivery of licence, certificate, or approval — with post-grant advisory.