Botswana’s medicines regulator has told importers, clearing agents and port of entry authorities that nine categories of medical devices and related equipment fall outside its current regulatory scope and require no BoMRA import clearance, permits or registration.
Consignments containing only listed items must be cleared without a BoMRA permit or clearance letter. Importers and clearing agents facing delays on these goods can cite the notice directly. Two categories are worth flagging for anyone servicing installed equipment or supplying diagnostics: spare parts and maintenance hardware for existing medical devices are exempt, and so are external quality assessment materials and proficiency testing panels — both frequent causes of hold-ups at entry.
- INDUSTRIAL USE: PPE intended strictly for industrial, occupational safety, or non-medical environments (e.g., industrial safety helmets, heavy-duty gloves, non-medical masks, industrial respirators).
- EXTERNAL QUALITY ASSESSMENT (EQA) & PROFICIENCY TESTING MATERIALS: Calibration standards, reference materials, and proficiency testing panels used strictly in laboratory quality assurance to validate and verify analyzer performance.
- GENERAL LABORATORY EQUIPMENT (NON-CLINICAL USE): General apparatus and equipment (e.g., beakers, pipettes, measuring cylinders, centrifuges) utilized in educational institutions, universities, water utility laboratories, and non-health settings that are not intended for clinical diagnostic purposes.
- MEDICAL DEVICES INCLUDING IVDS FOR STUDIES & EDUCATIONAL PURPOSES: devices solely for academic, training, or experimental use in universities and schools.
- MEDICAL TRAINING EQUIPMENT & SIMULATORS: Educational models, training devices, and anatomical simulators (e.g., artificial training lungs, CPR manikins) used for academic and training instruction.
- GENERAL WELLNESS & FITNESS DEVICES: Products intended solely for general wellness, fitness tracking, or lifestyle monitoring used by individuals (e.g., smartwatches, pulse monitors for sports/jogging, body composition scales, and general fitness monitors) that are not intended for clinical diagnosis, disease prevention, or hospital treatment.
- BREATHALYZERS & SCREENING EQUIPMENT: Alcohol breathalyzers, roadside sobriety testing units, workplace alcohol screening tools, along with their associated accessories, calibration gases, and consumables, provided they are not intended for clinical or hospital diagnostic procedures.
- SPARE PARTS & ACCESSORIES FOR MEDICAL DEVICES: Replacement components, maintenance hardware, and spare parts imported for the repair or servicing of existing equipment.
- FORENSIC/LAW‑ENFORCEMENT TEST KITS: Tests intended only for law enforcement or other non‑medical purposes (e.g., certain drug‑abuse tests used solely in forensic settings).
The exemptions turn on intended use rather than the product itself. Several categories are qualified — wellness devices, breathalysers and laboratory equipment are exempt only where not intended for clinical diagnosis or hospital use — so the same item may or may not require clearance depending on its declared purpose and destination. Importers should expect intended use to be the point of scrutiny at entry.
BoMRA described the position as reflecting the current phase of regulatory implementation and reserved the right to bring any of these categories into active oversight later, with formal public notice before enforcement. The notice does not state how intended use is to be evidenced at the border, how mixed consignments containing both exempt and regulated items are treated, or how this position relates to the draft regulations under the Medicines and Related Substances Act 2025 now out for comment.
Source: Botswana Medicines Regulatory Authority — https://www.bomra.co.bw/clarification-on-medical-devices-and-laboratory-equipment-currently-out-of-regulatory-scope-for-import-control/
