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CALL FOR VOLUNTARY PRIORITY BASED REGISTRATION OF MEDICAL DEVICES INCLUDING IVDS

CALL FOR VOLUNTARY PRIORITY BASED REGISTRATION OF MEDICAL DEVICES INCLUDING IVDS

CALL FOR VOLUNTARY PRIORITY BASED REGISTRATION OF MEDICAL DEVICES INCLUDING IVDS

As mandated by the Medicines and Related Substances Act of 2013, Botswana Medicines Regulatory Authority (BoMRA) is calling on applicants to register their medical devices including In Vitro Diagnostics (IVDs) with the Authority as a step towards availing safe, quality and effective medical devices to Botswana.


Applicants are strongly encouraged to familiarize themselves with the criteria and requirements outlined in the Registration Guideline and other relevant guidance documents published on the BoMRA website before submitting their applications.


Voluntary registration will commence on 1st October 2023 and continue for the following 6 months
until 31st March 2024. Note that this is a transition period aimed at preparing applicants for mandatory
registration, which shall commence on 1st April 2024. Voluntary registration will be subjected to the current Registration Fees and the stipulated timelines.


This voluntary registration will be as per the priority list mentioned below. However the priority list will be updated periodically as and when necessary.


The priority list is given below;
In Vitro Diagnostic Medical Devices Prequalified by WHO: HIV; Malaria; Hepatitis A; Hepatitis B; HPV;
G6PD; Cholera; Syphilis; Tuberculosis NAT; etc. The link to the In Vitro Diagnostic Medical Devices Prequalified by WHO is as follows: https://extranet.who.int/pqweb/vitro-diagnostics/vitro-diagnostics-lists

Locally Manufactured Medical Devices: Medical masks; medical gloves; medical gowns; Viral Transport Media; Vacuum blood collecting tubes; etc.


High Risk Medical Devices and Medical Devices of Importance:

  • Medical implants;
    » Heart Implants (Cardiac Stents, Cardiac Pacemakers, Implantable Defibrillators, Implantable
    Cardiac Recorders)
    » Central Nervous System Implants (Neuro Implants, Spine Implants)
  • Contraceptive Devices (Condoms and their Lubricants);
  • Pregnancy test kits


For any enquiries kindly contact: medicaldevices.services@bomra.co.bw

Registration Guidelines and other relevant guidance documents can be accessed on the BoMRA website using the following link: https://www.bomra.co.bw/medical-devices

REGISTRATION-OF-MEDICAL-DEVICES-INCLUDING-IVDSDownload

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BoMRA Background

The Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.

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Dr. Seima Dijeng

Dr Seima Dijeng is the Chief Executive Officer (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