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Medical Devices


Medical Devices

The Botswana Medicines Regulatory Authority (BoMRA) is responsible for regulating medical devices, including In vitro Diagnostics (IVDs), to ensure compliance with rigorous standards of safety, quality, and efficacy. BoMRA oversees the registration, licensing, and importation of medical devices to prioritize patient safety and maintain the quality standards of medical devices within Botswana’s healthcare system.


Medical Device

means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings and animals for one or more of the specific purposes of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease 

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury

– investigation, replacement, modification, or support of the anatomy or of a physiological process

– supporting or sustaining life

– control of conception

– Cleaning, disinfection and sterilization of medical devices or

– providing information for medical purposes by means of in vitro examination of specimens derived from the human body and

which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Note: An accessory is considered to be a medical device where an accessory is intended specifically by its manufacturer to be used together with the ‘parent’ medical device to enable the medical device to achieve its intended purpose, it should be subject to the same procedures that apply to the medical device itself.

In Vitro Diagnostic Device

Or its acronym “IVD” means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimen derived from the human or animal; solely or principally to provide information for diagnostic, monitoring or compatibility purposes which includes but not limited to – reagents used for IVD purposes, calibrators, control chemicals, specimen receptacles, software and related instruments or apparatus or other articles and are used for the following test purposes; diagnosis; aid to diagnosis; screening; monitoring; predisposition; prognosis; prediction; determination of physiological status.


Medical devices including IVDs are classified into one of four classes where Class A represents the lowest risk and Class D the highest. Some of the risk indicators used to create the Classification Rules: degree of invasiveness, duration of contact, body system affected, supporting or sustaining life etc. It is the intended use of a device that primarily determines its class. Classification must be consistent with the claims that appear on the manufacturer’s label and advertisement for the device.

Classification of Medical Devices

(a)        Class A – low risk;

(b)        Class B – low to moderate risk;

(c)        Class C – moderate to high risk;

(d)        Class D – high risk


Classification of In-vitro Diagnostics Medical Devices

(a)        Class A – Low Individual Risk and Low Public Health Risk

(b)        Class B – low public health risk or moderate individual risk;

(c)        Class C – moderate public health risk, but high individual risk; and

(d)        Class D – High Individual Risk and High Public Health Risk

Location of risk classification guideline: https://bomra.co.bw/downloads/#51-114-wpfd-adopted-guidelines-1657004433


BOMRA aims to strengthen the oversight of medical devices in Botswana, enhance patient safety, and maintain the quality standards of medical devices throughout their lifespan in the healthcare system.


Identification of pertinent standards and clinical data


Appraisal of each individual data set, in terms of its relevance, applicability, quality and clinical significance.


Analysis of the individual data sets, evaluation of the performance, safety, and presentational aspects of the medical device are reached.


At the end of the clinical evaluation a report is prepared and combined with the relevant clinical data to form the clinical evidence for the medical device.

The registration of medical devices

Interested applicants can apply for medical device registration through following routes:

  • Screening only/Notification (for Non-Sterile, Non-Measuring Class A, Veterinary medical device, General Laboratory equipment.)
  • Abridged (for medical devices approved by any Reference Regulatory authority or WHO, following policy BoMRA/ER/MED/Policy 01)
  • Full Assessment (for all other medical devices)
  • WHO’s Collaborative Registration Pathway

Currently, a transitional arrangement allows the importation of medical devices through the listing or exemption from registration process. This arrangement aims to facilitate trade, ensure business continuity, and maintain access to medical devices. However, starting from 1st October 2023, BOMRA will initiate a voluntary priority-based registration system for medical devices. From 1st of April 2024, registration shall be mandatory for all medical devices (according to the priority medical devices list). Importation of medical devices without BoMRA approval, except for those that are registered, listed, or exempted, will be strictly prohibited. These regulations prioritize patient safety and ensure the quality of medical devices within Botswana’s healthcare system.


Priority List for Registration

  • Medical Implants
    1. Heart
    2. Central Nervous System implants
      1. Includes Spine and Neuro Implants
    3. Condoms and their lubricants
    4. Pregnancy test kits
    5. WHO Prequalified IVDs
    6. Locally manufactured medical devices

Licensing of Medical Device Establishments

BoMRA will publish a Licensing Call-Up Plan to inform stakeholders about the licensing process for medical device establishments. This plan will outline the type and class of medical device establishments that will be prioritized and sequentially called up for licensing.


Name File
Act Visit
Regulation Visit
Registration of medical devices (Guideline) Visit
Registration of medical devices (Form) Visit
Exemption of medical devices (Guideline) Visit
Exemption of medical devices (Form) Visit
Listing of Medical Devices (Guideline) Visit
Listing of Medical Devices (Form) Visit
Listing of Medical Devices Establishments (Guideline) Visit
Listing of Medical Devices Establishments (Form) Visit
Fees Visit

Guidelines and Important Downloads

Dr. Seima Dijeng

Dr Seima Dijeng is the Acting CEO of BoMRA. Before assuming the acting appointment role, he served as the Director of Licensing and Enforcement, overseeing inspections and licensing of premises, laboratory services, import and export control, and enforcement.

A career regulatory professional with over 15 years of experience across both the food and pharmaceutical sectors. He has been part of the BoMRA executive management since 2018.

During his tenure as the Director, he coordinated the development of structures, processes, and guidelines to support regulatory activities and services for the licensing and enforcement department.

He holds a Master of Science in Food, Safety, and Risk Analysis from University College Dublin, the Republic of Ireland, Bachelor of Veterinary Science, from the University of Queensland in Australia.

Dr. Kefentse Motshegwa

Dr. Motshegwa is the Director of Veterinary Services at the Ministry of Agriculture. His illustrious career in veterinary services spans over 23 years in various positions within the veterinary space.

He previously served as Deputy Director – Compliance at the Department of Veterinary Services, Chairperson of the National Residue Committee, and Coordinator of Performance of Veterinary Services Evaluation for the World Organisation for Animal Health founded as OIE.

He brings to the Board a wealth of experience in compliance and regulation in animal health, food safety & veterinary medicines. He is a member of the Botswana Vaccine Institute Board of Directors.

He holds a Master of Science in Biology and Control Parasitic Diseases and Vectors from the University of Liverpool, School of Tropical Medicine, and a Bachelor of Veterinary Medicine from the University College Dublin, Ireland

Dr. Ditiro Duma Coyne

Dr. Coyne is a veterinarian with a career spanning over 15 years in mixed private practice in Gaborone. He has been actively involved in animal welfare and has been the veterinary advisor to the Botswana Society for the Prevention of Cruelty to Animals for several years.

He was the President of the Botswana Veterinary Association for 8 years and has made great strides in advancing Continuous Professional Development for Veterinarians in the country. He brings to the Board vast experience in veterinary education and advocacy as well as Animal Health and Production.

He is currently the World Small Animal Veterinary Association Country Representative for Botswana.

He holds a Bachelor of Veterinary Medicine and Surgery, and a Bachelor of Sciences Veterinary Biology both from Murdoch University, Australia.

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia