Botswana Medicines Regulatory Authority (BoMRA) Calls On Medical Devices Distributors To Register

• Botswana Medicines Regulatory Authority (BoMRA) is calling on all entities trading in medical devices to register with the Authority.
• This notice affects entities or individuals who manufacturer, distribute, sell, import & export medical devices including Personal Protective Equipment used in the detection, prevention, and control of COVID -19.
• BoMRA regulates the supply chain of all medical products to ensure that they conform to the set standards of safety, quality and efficacy, as such BoMRA would like to develop a database of those dealing with medical devices that are in circulation for monitoring and ease of communication with the industry.

HOW TO REGISTER

Online registration via the website – www.bomra.co.bw

BoMRA Background

In essence, the Botswana Medicines Regulatory Authority team works round the clock to provide integral regulatory services to its valuable stakeholders. The introduction of an independent regulator was primarily to facilitate the separation of service delivery from regulatory functions where the regulatory unit was acting as a referee and a player resulting with inadequate regulation.

Quality Management System

BoMRA is committed to implementing a Quality Management System (QMS) in order to coordinate and direct the organisation’s activities and adequately execute its regulatory mandate. In implementing QMS we expect to continually improve the efficiency and effectiveness of our processes and thereby meet and exceed our customer needs and stakeholder requirements.

Our Quality Management Unit has thus been mandated to facilitate the implementation of the Quality Management System throughout the organisation in order for BoMRA to achieve International Organisation of Standardisation (ISO) certification and accreditation. This will assist BoMRA in achieving its Vision of being “The trusted Authority for excellence in medical products and cosmetics regulation”.

In addition to achieving operational excellence, BoMRA will continually improve on its Safety, Health and Environment Management (SHE) to ensure that all matters relating to the safety of operations, the health of employees, and the environments in which they work in are conducive to promoting high performance, innovation and continuous improvement.