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          • Ministry of Health (MoHW)

          • Memorandum of Understanding (MOU)

        • BoMRA and Special Economic Zones Authority sign a SLA

          BoMRA and Special Economic Zones Authority sign a SLA

          Botswana Medicines Regulatory Authority (BoMRA) and Special Economic Zones Authority (SEZA) sign a Service Level Agreement (SLA) Efforts to develop

          Read More
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  • ORGANISATION
        • ABOUT US

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        • PEOPLE

          • Organogram
          • Executive Management
          • Staff
        • STRATEGIC PARTNERSHIP

          • Botswana Unified Revenue Service (BURS)

          • Botswana Bureau of Standards (BOBS)

          • Univesity of Botswana (UB)

          • Radiation Protection Inspectorate (RPI)

          • Ministry of Health (MoHW)

          • Memorandum of Understanding (MOU)

        • BoMRA and Special Economic Zones Authority sign a SLA

          BoMRA and Special Economic Zones Authority sign a SLA

          Botswana Medicines Regulatory Authority (BoMRA) and Special Economic Zones Authority (SEZA) sign a Service Level Agreement (SLA) Efforts to develop

          Read More
  • LEGISLATION
        • REGULATIONS

          • Government Gazette
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          August Tenders
          August 31, 2023
          Explore More Tenders

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            August 4, 2023
          • Strategy & Risk Manager
            June 5, 2023
          Explore More Careers
  • e-SERVICES
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        • Register a Complaint
        • Report Sale of Illegal Products
        • Report-an-Issue

          • Report Adverse Drug Reactions

          • Report Sale of Illegal Products

          • Report Adverse Events Following Immunization (AEFI)

          • Rapid Alerts

          • PMS Quality Complaints Form

          • Customer Complaints Form

          Register

          • Cosmetics Stake Holder Form

          • Registration of Distributors

          • Report Medical Device Adverse Events (MDAE)

          • Listing of Medical Device Establishment Form

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 Covid19 Updates

Report Medical Device Adverse Events (MDAE)

Report Medical Device Adverse Events (MDAE)

  • Report Medical Device Adverse Events
docx

Medical Device Adverse Event (MDAE) Reporting Form for Market Authorization Holders BOMRA-PCT-PV-P10-F02 Issue 1.1

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Date added: 05-05-2023
Date modified: 05-05-2023
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docx

Medical Device Adverse Event (MDAE) Reporting Form for HCP and Users BOMRA-PCT-PV-P10-F01 Issue 1.1

Size: 186.91 KB
Hits: 100
Date added: 05-05-2023
Date modified: 05-05-2023
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pdf

Guideline - National Guidelines for Medical Device Adverse Event Reporting PCT-PV-P10-G01 Iss 1

Size: 357.00 KB
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Date added: 05-05-2023
Date modified: 05-05-2023
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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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