The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform all relevant stakeholders of the implementation of regulatory requirements for medical devices, including in vitro diagnostics (IVDs), under the Medical Device Regulatory Roadmap.
The roadmap supports Botswana’s progressive strengthening of medical device regulation in line with internationally recognized regulatory principles. The framework aims to protect patients, healthcare professionals, and the public while facilitating access to safe, quality-assured medical devices.

1. Class A Notification Registration
   BoMRA is issuing a call for notification registration for the following products:

• Class A medical devices, including Class A IVDs;
• Veterinary-use-only medical devices, including IVDs; and
• Class A dental medical devices and applicable dental consumables.

Classification and Regulatory Pathway: Before submitting an application, stakeholders must verify the applicable product risk classification and confirm the correct regulatory pathway

Implementation Timeline: Voluntary Transition Phase
During this period:

• Notification registration will be voluntary from 1 October 2026 – 31 March 2027.
• The applicable application fee will be USD 185 or the equivalent amount in Botswana Pula.
• Fully locally manufactured devices will qualify for a 50% fee reduction, resulting in an applicable fee of USD 92.50 or the equivalent amount in Botswana Pula.
• Partially locally manufactured devices will qualify for a 25% fee reduction, resulting in an applicable fee of USD 138.75 or the equivalent amount in Botswana Pula.

Importation and Transitional Facilitation of dental devices and veterinary devices

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