Call for Mandatory Registration of Who Prequalified IVDS and Extension of Voluntary Registration of Other Priority Medical Devices Including IVDS

Call for Mandatory Registration of Who Prequalified IVDS and Extension of Voluntary Registration of Other Priority Medical Devices Including IVDS

Call for Mandatory Registration of Who Prequalified IVDS and Extension of Voluntary Registration of Other Priority 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 through voluntary and mandatory registration as stipulated below.

VOLUNTARY REGISTRATION

n line with the requests from the valuable stakeholders, BOMRA has acceded to the extension of the voluntary registration for priority medical devices to 30th June 2024, this excludes WHO Prequalified IVDs. Voluntary registration will be as per the following updated priority list:

  • 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.
  • All locally manufactured medical devices: such as: Medical Masks; Medical Gloves;
  • Medical Gowns; Viral Transport Media; Vacuum Blood Collecting Tubes; Hospital
  • Furniture etc

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