BoMRA Medical Device Registration & Authorized Representative Botswana
BoMRA has introduced a phased mandatory registration roadmap based on risk class, Once a deadline passes, unregistered devices are removed from the Listing Register and must be in the Registration Register:: the Class C and D deadline passed on 30 June 2026, Class B closes on 31 March 2027 and Class A on 30 September 2027. NexorTest delivers end-to-end BoMRA registration under the new Medicines and Related Substances Act 2025: Class A to D and IVD classification, notification, abridged reliance and full evaluation dossiers, BRIMS filing, independent Local Technical Representative services, import permit coordination and post-market vigilance, all under one expert roof.
Four Risk Classes Under Botswana’s 2026 Regulations
BoMRA applies GHTF and IMDRF aligned rules to general devices and a separate public-health weighted rule set to IVDs. Your class decides the pathway, technical dossier, deadline and post-market duties.
Class A Devices
Most non-invasive devices, wound dressings used as a mechanical barrier, reusable surgical instruments and transient orifice-invasive devices. Class A IVDs include specimen receptacles and buffer and wash solutions.
- Notification
- Self-Declaration
- Deadline Sep 2027
Class B Devices
Short-term orifice-invasive and transient surgically invasive devices, most diagnostic active devices and X-ray recording media, such as urinary catheters and tracheal tubes. Blood-glucose self-monitoring IVDs are Class B.
- ISO 13485
- Abridged Eligible
- Deadline Mar 2027
Class C Devices
Breast implants, joint replacements, blood bags, contact lens care solutions and hazardous energy-delivering devices. IVDs for syphilis, malaria, tuberculosis and most self-tests are Class C.
- Third-Party Cert
- Deadline Passed
Class D Devices
Devices in contact with the heart, central circulation or CNS, spinal disc replacements, devices with an ancillary medicinal substance and ingested or inhaled nanomaterials. HIV, hepatitis and blood-grouping IVDs are Class D.
- UDI Phase 1
- PSUR & PMCF
- Deadline Passed
Three Routes to BoMRA Registration
The pathway you qualify for, driven by class and the approvals you already hold, is the biggest lever on your Botswana timeline and cost.
Abridged Evaluation
Reliance on Recognised Authorities
For devices already approved by a BoMRA-recognised reference regulatory authority or WHO prequalified. BoMRA relies on the prior assessment instead of repeating it, while keeping full decision-making authority.
- IMDRF members & WHO Listed Authorities
- ML3/ML4 regulators & AMDF-recognised bodies
- Eligibility checked per device
Notification
Class A Notification
For non-sterile, non-measuring Class A devices, veterinary-use devices and general laboratory equipment for clinical use. A screening-only review with a reduced document set, built around the LTR appointment and labelling.
- Self-declaration of conformity
- Opened 1 October 2026
- Deadline 30 September 2027
Full Evaluation
Comprehensive Technical Review
For devices with no recognised prior approval, novel technologies or files that do not meet abridged criteria. BoMRA reviews the full technical documentation, clinical evidence, QMS and labelling, and may request samples or testing.
- Full STED / IMDRF ToC dossier
- Clinical or performance evidence
- Technical expert committee input
Comprehensive Botswana Regulatory Services
From Local Technical Representative appointment and classification through BRIMS filing, import permits, retention and vigilance, NexorTest manages every step of your BoMRA journey.
Independent Local Technical Representative
We act as your Botswana-incorporated LTR and authorised representative, holding registrations neutrally so you can appoint, add or replace importers and distributors without re-registering. We also manage LTR transfers on Form BOMRA/MD 3.
Classification & Scope Check
Rule-by-rule classification under the 2026 Schedules for devices and IVDs, borderline and combination product determinations, and a check against BoMRA’s September 2026 out-of-scope list.
Abridged Reliance Dossiers
We convert your FDA, CE, TGA, Health Canada, PMDA, MHRA, HSA or WHO PQ approval into a reliance file with the reference evidence and marketing history BoMRA expects.
Full Evaluation & STED Files
STED or IMDRF ToC dossiers with Essential Principles checklist, ISO 14971 risk file, verification and validation, sterilisation, biocompatibility and clinical evaluation for Class C and D.
Class A Notification Programme
Portfolio-scale notification of eligible non-sterile, non-measuring Class A devices ahead of the 30 September 2027 deadline, built to clear BRIMS screening first time.
BRIMS Filing & Query Management
BRIMS account set-up, combined screening and evaluation submissions, fee payment and complete, on-time responses so the stopped review clock restarts quickly.
Licensing & Import Permits
Coordination with licensed importers and distributors, establishment licence readiness including biomedical-engineering key personnel, and per-consignment BRIMS permits.
Labelling, UDI & Advertising
English labels and IFU to the 2026 Regulations, ISO 15223 symbols, UDI-DI planning by phase, eIFU risk assessments and prior BoMRA approval of advertising material.
IVD Registration
Class A to D IVD strategy with analytical and clinical performance, stability and usability evidence, including Class D HIV, hepatitis and blood-grouping assays and Class C self-tests.
SaMD, AI & Cybersecurity
IMDRF-aligned SaMD classification, IEC 62304 lifecycle, cybersecurity evidence, AI training-data governance and bias mitigation, and predetermined change control plans.
Vigilance, FSCA & Recalls
72-hour serious incident reporting on Form BOMRA/MD 6, 3-day FSCA notification on Form BOMRA/MD 8, field safety notices, recalls and trend reporting.
Retention, Variations & Renewals
Annual retention fee tracking so devices are never struck off, major, minor and notification variations, and five-year renewals filed at least six months before expiry.
Botswana’s Trusted BoMRA Registration Partner
We combine in-country representation with global reference-market expertise to deliver faster, more predictable BoMRA approvals.
Independent LTR, No Distributor Lock-In
Your registrations stay in a neutral holder’s hands, so changing commercial partners never means losing your BoMRA authorisation or starting again.
Current to November 2026
Our playbooks already cover MRSA 2025, the 2026 Medical Devices Regulations, the June 2026 deadline roadmap and the September 2026 scope clarification, changes many published guides still miss.
Deadline-Driven Portfolio Planning
We sequence your Class B, then Class A, filings against the 2027 deadlines and track retention anniversaries so no device drops off the register.
One Plan for Southern Africa
Reuse one IMDRF-format dossier across Botswana, South Africa and wider SADC markets, adapted per country, instead of paying for separate files.
Transparent Fixed-Fee Packages
Milestone pricing from classification to registration certificate, with BoMRA fees in Pula passed through at cost and no hourly surprises.
Six Steps to Your BoMRA Registration
A reliance-first, deadline-aware approach that minimises BoMRA queries and gets your device into Botswana hospitals and clinics faster.
Classification, Scope & Deadline
We confirm your class, check the out-of-scope list and map each product to its mandatory registration deadline.
Appoint Independent LTR
NexorTest is appointed as your Local Technical Representative on Form BOMRA/MD 3, keeping registrations independent of any distributor.
Pathway & Dossier
We select notification, abridged or full evaluation and compile the STED, reference approvals, QMS, clinical evidence and English labelling.
BRIMS Submission
We file on BRIMS, pay the combined screening and evaluation fee and clear the completeness check.
Evaluation & Queries
We answer every BoMRA query completely and on time so the paused review clock restarts without delay.
Registration, Permits & Post-Market
You receive the certificate; we coordinate consignment permits and run retention, vigilance, variations and five-year renewals.
BoMRA Expertise Across Every Device Category
From consumables to implants, IVDs and AI software, our specialists cover the full breadth of medical technology entering Botswana.
- 🫀 Cardiovascular & Implants
- 🧬 In Vitro Diagnostics
- 🧪 HIV, TB & Malaria Testing
- 🤖 AI & SaMD
- 🩻 Imaging & Radiology
- 🦴 Orthopaedics
- 💉 Infusion & Drug Delivery
- 🩸 Surgical Instruments
- 👁 Ophthalmics
- 🦷 Dental Devices
- 🩹 Wound Care & Consumables
- 🏥 Hospital & ICU Equipment
BoMRA Registration Botswana FAQ’s
What is BoMRA medical device registration in Botswana?
BoMRA medical device registration is the marketing authorisation issued by the Botswana Medicines Regulatory Authority, the national regulator for medicines, medical devices including IVDs, and cosmetics. Devices are regulated under the Medicines and Related Substances Act, 2025 (Act 29 of 2025), which Parliament passed in December 2025 to replace the 2013 Act, together with BoMRA guidelines and the Medical Devices including In Vitro Diagnostics (IVDs) Regulations, 2026, which come into operation on a date set by Ministerial Order. Applications are filed electronically on the BoMRA Regulatory Information Management System (BRIMS). Registration is now mandatory on a phased, risk-based schedule: Class C and D devices had to be registered by 30 June 2026, Class B devices must be registered by 31 March 2027 and Class A devices by 30 September 2027.
Do I need a Local Technical Representative to register a medical device in Botswana?
Yes. BoMRA accepts device applications from manufacturers or their authorised representatives, and an applicant that is not a local entity must appoint a Local Technical Representative (LTR) resident or incorporated in Botswana. Under the 2026 Medical Devices Regulations the LTR handles all communication with BoMRA, monitors registered devices on the market and immediately reports problems that may endanger public health, handles recalls and supports device users. The appointment is documented on Form BOMRA/MD 3 with a written mandate from the manufacturer. Many registrations are held through a distributor, which ties the manufacturer to that distributor. NexorTest acts as an independent Local Technical Representative so you can appoint or change importers and distributors without losing control of your registrations.
How are medical devices and IVDs classified in Botswana?
BoMRA uses a four-tier, GHTF and IMDRF-aligned risk system for both general medical devices and IVDs. Class A is low risk, Class B low to moderate risk, Class C moderate to high risk and Class D high risk. General devices are classified with 20 rules covering invasiveness, duration of contact, body part and active function; for example, reusable surgical instruments are Class A, breast implants, joint replacements and blood bags are Class C, and devices in direct contact with the heart, central circulatory system or central nervous system are Class D. IVDs are classified by individual and public health risk: tests for HIV, hepatitis B, C and D and blood grouping are Class D, while tests for syphilis, malaria and tuberculosis are Class C. Where more than one rule applies, the higher class is used.
What are the BoMRA mandatory registration deadlines for medical devices?
BoMRA’s June 2026 regulatory update sets risk-based deadlines. Class C and D devices could register from April 2024 and the mandatory deadline was 30 June 2026. Class B registration opened on 1 April 2026 with a deadline of 31 March 2027. Class A registration (notification) opened on 1 October 2026 with a deadline of 30 September 2027. Once a deadline passes, a device is removed from the Listing Register and can only be supplied if it is on the Registration Register. Variation applications have been accepted since April 2025.
What registration pathways does BoMRA offer for medical devices?
There are three pathways. The Notification pathway is for non-sterile, non-measuring Class A devices, veterinary-use devices and general laboratory equipment for clinical use. The Abridged Evaluation pathway relies on prior approval by a recognised reference regulatory authority or WHO prequalification, which reduces documentation and review effort. The Full Evaluation pathway applies to devices with no recognised prior approval, novel technologies or devices that do not meet abridged criteria. BoMRA may reassign a device to a different pathway after assessment.
How long is a BoMRA medical device registration valid?
Under the 2026 Medical Devices Regulations, a registration is valid for five years from the date of issue, provided annual retention fees are paid, registration conditions are met and the registration is not suspended or cancelled. BoMRA states that failure to pay annual retention fees by the anniversary date results in immediate removal from the register, for both listed and registered devices. Renewal is applied for at least six months before expiry with updated device information, a post-market surveillance summary, periodic safety update reports for Class C and D, a summary of changes and evidence of continued QMS compliance.
Do I need an import permit or establishment licence for medical devices in Botswana?
Yes. Since 1 April 2025 all local manufacturers, wholesalers, importers and distributors of medical devices must hold a BoMRA licence instead of an establishment listing, and every consignment of medical devices and IVDs entering or leaving Botswana needs a permit and import fee through BRIMS. Under the 2026 Regulations, distributors and wholesalers handling Class B, C and D devices and capital equipment must have a biomedical engineer, biomedical engineering technician or other relevant key personnel registered with a professional body. Product registration and the importer’s licence and permit are separate requirements, so both must be in place before goods ship.
What changes under the MRSA 2025 and the 2026 Medical Devices Regulations?
The Medicines and Related Substances Act, 2025 expands the law from 69 to 125 sections and moves Botswana from the WHO Global Model Regulatory Framework basic level to the expanded level of device control. BoMRA published the Medical Devices including IVDs Regulations, 2026 in September 2026; they come into operation on a date set by Ministerial Order. Key provisions include five-year registration validity, codified notification, abridged and full pathways, reliance on IMDRF and WHO-listed authorities, a phased UDI system starting with Class D, dedicated SaMD, cybersecurity and AI rules including predetermined change control plans, prior approval of advertising, English-language labelling and structured vigilance and field safety corrective action reporting. Devices authorised before commencement remain valid until their authorisation expires.
Which products are outside BoMRA medical device import control?
On 4 September 2026 BoMRA clarified that nine categories are currently outside medical device import control: PPE for industrial or non-medical use; external quality assessment and proficiency testing materials; general laboratory equipment not used for clinical diagnosis; devices and IVDs used only for study or education; training equipment and simulators such as CPR manikins; general wellness and fitness devices such as smartwatches; breathalysers and non-clinical screening equipment; spare parts for servicing existing equipment; and forensic or law-enforcement test kits. BoMRA may bring any of these into scope later by public notice, so intended use must be checked case by case.
Ready to Enter the Botswana Medical Device Market?
Get a free BoMRA regulatory assessment. We’ll confirm your class and deadline, check reliance eligibility, and map your fastest path to registration and your first import permit.