MANDATORY 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 through mandatory registration as stipulated below.

MANDATORY REGISTRATION
The ongoing mandatory registration scope will be as per the priority list given below and will be updated periodically as and when necessary:

IN SCOPE
Mandatory registration is currently applicable to the following medical devices including IVDs:

1. WHO Prequalified IVD test kits or same IVD test kits approved by Stringent Regulatory Authorities (SRAs – US FDA, Health Canada, Australia, Japan EU, UK). The link to the WHO PQ IVDs is as
   follows: https://extranet.who.int/prequal/vitrodiagnostics/prequalified-vitro-diagnostics.
2. All Instruments compatible with WHO PQ / SRA approved IVD test kits (should be applied for separately).
3. All locally manufactured (includes full and part manufacturing) medical devices including IVDs.
4. All SRA approved contraceptive devices (and their lubricants), pregnancy test kits and implants for central nervous system. SADC approved contraceptives will also be accepted.
5. The following Maternal Newborn and Child Health (MNCH) devices that are SRA approved: (neonatal ventilators, CPAP ventilators, Oxygen blenders, Oxygen concentrators, pulse oximeters, humidifiers, flow splitters, suction
   pumps, bilirubinometer, phototherapy lights, radiant warmers, infant incubators, mobile diagnostics ultrasound scanners, fetal dopplers, non-pneumatic anti-shock garments, vacuum extractors, blood pressure machines and hemoglobinometers).

OUT OF SCOPE

1. All listed and non-listed medical devices including IVDs which do not form part of the mandatory registration scope above will continue to be imported through the ‘Exemptions Process’ if they are not already part of the listed medical devices database. Link to the listing database: https://www.bomra.co.bw/downloads/#51-127-wpfdmedical-devices-register.
2. All imported Class A low risk medical devices including IVDs.

NOTE:

1. Applications are received through our online service portal link: https://brims.bomra.co.bw/
2. All medical devices called for registration will be removed from the medical devices listing register effective from 1st April 2025. All other remaining listed medical devices will be subjected to an annual retention fee to retain them in listing register, retention fees should be paid between 1st January – 31st March 2025. All medical devices including IVDs not retained will be removed from the listing register from the 1st of April 2025.

Registration will be subjected to the current BoMRA fees in the Regulations of 2019 and the stipulated timelines as per the registration guidelines in the following link: https://www.bomra.co.bw/bomradownloads/#132-329-wpfd-registration-screeningquery-response.

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