Botswana medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• For the import of medical devices into Botswana, registration of the product and an import licence are both mandatory: the importer must hold a registration certificate for the product and an import licence, and the main requirements for import or export control are identification of a local representative (a registered manufacturer or distributor holding a BoMRA licence), a market authorisation certificate from the country of origin, the import/export licence, and registration of the product.
• A foreign applicant must appoint a Local Technical Representative (also called an Authorized Representative) which must be a company residing in Botswana or incorporated in Botswana, and the LTR is the applicant of record taking responsibility for compliance (G01 s.3.1.3).
• Technical dossier submissions are made in electronic format through the BRIMS Self Service Portal, and a separate and complete product dossier is required for each grouping — one single device, device family, device system or device group per application (G01 ss.4.1(i), 4.6 and 4.7).
• A Class B, C or D application goes through screening first and evaluation second: once the application is accepted and the screening fee paid, processing follows the s.4.15 timeline, and once a query is raised processing halts until the response is received — two query cycles are allowed and no response within the published timeline is deemed withdrawal of the application (G01 s.4.8).
• Evidence of conformity to the Essential Principles of Safety and Performance must be provided by completing the Essential Principles checklist in BOMRA/ER/MED/P04/G04, identifying the applicable principles and the full title, identifying number and date of each standard applied, with declarations or certificates of conformity to those recognized standards (G01 s.6.2).
• The Class B, C and D dossier must include proof of a quality management system such as an ISO 13485 certificate or equivalent, the Declaration of Conformity, the Certificate of Compliance with Recognized Standards, a post-market surveillance plan, an executive summary, the Summary Technical Documentation and device labelling (G01 Table 3).
• A device registration is valid for five years unless suspended or revoked by BoMRA or terminated by the registrant, and its validity is subject to payment of annual retention fees as prescribed in the fee regulations in force, submission of post-marketing surveillance reports and submission of adverse-effect reports associated with the device; renewal applications must be made six months before expiry (G01 ss.4.10 and 4.14).
• Every consignment must be accompanied by an import permit and an original proforma invoice, devices are inspected on arrival at the ports of entry by BoMRA inspectors or a designate before release, and no importation through ordinary or registered post is sanctioned (BoMRA import/export guideline, s.10).
• The out-of-scope categories in BoMRA's public notice of 4 September 2026 do not require BoMRA import clearance, permits or registration: industrial-use PPE, external quality assessment and proficiency testing materials, general laboratory equipment for non-clinical use, devices for studies and educational purposes, medical training equipment and simulators, general wellness and fitness devices not intended for clinical diagnosis, disease prevention or hospital treatment, breathalysers and screening equipment not intended for clinical or hospital diagnostic procedures, spare parts and accessories for the repair or servicing of existing equipment, and forensic or law-enforcement test kits.