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BoMRA · Middle East & Africa

Botswana medical device regulatory resources

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4 free resources23/25 topics with records16 regulations tracked
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Medical device regulations

Browse Botswana's official medical-device instruments — the 2025 Medicines and Related Substances Act and its medical-device regulations, and BoMRA's registration, classification, labelling, reliance, import and vigilance guidelines — with citeable English passages.

Structured regulatory requirements

Explore all 56 source-linked facts →

23 of 25 research dimensions currently covered · 26 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
BoMRA is the competent authority for medical devices, which it regulates as 'medicines' under the MRSA 2013
The Botswana Medicines Regulatory Authority (BoMRA) is the national regulatory authority for medical devices. The Medicines and Related Substances Act, 2013 does not create a separate devic…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
The Medical Devices including IVDs Regulations, 2026 and the Fees, Levies and Penalties Regulations, 2026 are unpublished drafts
BoMRA has published the Medicines and Related Substances (Medical Devices including In Vitro Diagnostics) Regulations, 2026 and the Medicines and Related Substances (Fees, Levies and Penalt…
MRSA 2013 s.23(1) prohibits import, export, manufacture, distribution, sale, promotion or advertising of an unregistered medicine, and 'medicine' includes any medical device
The registration obligation that governs medical devices sits in section 23(1) of the MRSA 2013, which prohibits importing, exporting, manufacturing, distributing, selling, promoting, adver…
3 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
In-vitro diagnostic medical devices are regulated inside the medical device framework, with separate classification and registration guidelines
IVDs are treated as a subset of medical devices rather than a separate product category. BoMRA's Essential Principles guideline applies to 'all medical devices, including in vitro diagnosti…
The device definition in force is the MRSA 2013 section 2 definition
The operative definition of a medical device is the MRSA 2013 section 2 definition: an instrument, apparatus, implement, implant, medical equipment, machine, contrivance or other related ar…
2 source-linked facts
Checked 2026-09-16
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D04

Classification rules

Verified
BoMRA Classes A, B, C and D — medical devices excluding IVDs
Class A — Low Risk/Hazard, Class B — Low to Moderate Risk, Class C — Moderate Risk to high Risk, Class D — High Risk
1 maintained scheme · 2 related facts
Checked 2026-09-16
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D05

Registration pathways

Verified
Class B, C and D devices register through either full evaluation or abridged assessment
For general medical devices in Class B, C and D there are two registration pathways: full evaluation and abridged assessment. Full evaluation applies where the device has no prior approval…
IVD medical devices in Class B, C and D register through abridged or full assessment pathways
The IVD registration guideline mirrors the general device structure: applicants for IVD medical devices are guided on abridged and full registration assessment pathways, and the guideline a…
3 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
A prior approval from an SRA, an RRA, or WHO (with ISO 13485) opens the abridged assessment pathway
statement: For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA recognised Reference Regulatory Authority, or WHO prequalificati…
China NMPA approval is accepted only for Class A and Class B medical devices
statement: China's National Medical Products Administration is named as an acceptable reference authority in the exemption pathway, but the recognition is expressly limited to Class A and C…
8 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
An application for registration must be made by a company registered, licensed or operating in Botswana
Under MRSA 2013 s.24(2) the registration application must be made by a company registered, licensed or operating in Botswana, so a foreign manufacturer cannot apply in its own name.
A non-resident applicant must appoint a Local Technical Representative (Authorized Representative) resident or incorporated in Botswana
A foreign applicant must appoint a Local Technical Representative, also called an Authorized Representative, which must be a company resident or incorporated in Botswana; that representativ…
2 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Local device establishments moved from listing to formal licensing on 1 April 2025
From 1 April 2025 BoMRA replaced listing of medical device establishments with formal licensing: all local manufacturers, wholesalers, importers and distributors must hold a valid BoMRA lic…
Named non-medical and general-purpose categories are outside BoMRA's import-control scope and need no permit, clearance or registration
BoMRA's public notice of 4 September 2026 lists product categories that are currently out of regulatory scope and do not require BoMRA import clearance, permits or registration: industrial…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
The Class B, C and D dossier requires the online application form, letter of authorisation, ISO 13485 proof, device details, summary technical documentation, labelling information and the Essential Principles checklist
For a Class B, C or D general medical device, BoMRA requires a separate and complete electronic dossier for each single device, family, system or group, arranged as: the application form on…
Each registration application may contain only one grouping of medical devices
A registration application may contain only one grouping a single medical device, one device family, one device system, or one device group as prescribed in the Grouping guideline BOMRA/ER/…
2 source-linked facts
Checked 2026-09-16
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D10

Official forms & portals

Verified
Registration dossiers must be submitted electronically through the BRIMS Self Service Portal
Technical dossier submissions for registration must be made electronically through the BoMRA Regulatory Information Management System (BRIMS) Self Service Portal at https://brims.bomra.co.b…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Product labelling must be in English
BoMRA's labelling guideline requires that the product labelling of medical devices including IVDs be in English, and that all characters on labelling be of adequate size and legibly printed.
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Proof of an ISO 13485 or equivalent quality management system certificate is a mandatory dossier item
For Class B, C and D medical devices BoMRA requires proof of a quality management system, such as an ISO 13485 certificate or equivalent, as a mandatory item of the registration dossier. Th…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
BoMRA electrical safety and EMC evidence in the device dossier
Electrical safety
BOCRA communications equipment type approval
Wireless / radio
BOBS compulsory standards (Standards (Compulsory Standards) Regulations — Botswana Product Conformity Programme)
Import CoC / PVoC
5 maintained overlays · 6 related facts
Checked 2026-09-16
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D14

Fees

Unresolved
Listed and registered devices are retained annually against an applicable annual fee quoted through the BRIMS portal; no amount is published
Retention of a listed or registered device on the respective register is an annual process that involves payment of an applicable annual fee and submission of any additional product informa…
The draft 2026 Fees Regulations set differentiated device registration fees by risk class
The draft Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 would set medical device registration fees by risk class, with separate schedules for international…
4 source-linked facts
Checked 2026-09-16
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D15

Review clocks

Verified
Screening — all registration routes (Notification, Class A and B, Class C, Class D) · Application for screening lodged with the applicable screening fee through the BRIMS Self Service Portal; approval of the screening step is what allows the applicant to submit the evaluation application
1-3 months
Abridged evaluation — Class B, C and D (proof of a reference regulatory agency required) · Abridged evaluation route for Class B, C and D, whose dossier must additionally carry proof of the Reference Regulatory Agency and proof of that agency's marketing authorisation
4-8 months
Full evaluation — Class B, C and D, local manufacturer · Full evaluation route for a device manufactured in Botswana, with the complete Summary Technical Documentation dossier under G01 ss.6-8
6-10 months
7 maintained pathways · 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Annual retention is required to keep a device on the register, and failure removes it
Registration carries an ongoing annual obligation: MRSA 2013 s.24(4) requires the person who applied for registration to submit information annually in the prescribed manner with a prescrib…
Device registration is valid for five years; renewal is applied for six months before expiry
A device registration is valid for five years: BoMRA's in force registration guideline (BOMRA/ER/MED/P04/G01 Iss 3.0, s. 4.10) provides that the registration of a medical device shall be va…
3 source-linked facts
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Significant changes require a variation application; fundamental changes require a new dossier
A marketing authorisation holder must inform BoMRA of any significant change that could reasonably be expected to affect the safety or effectiveness of a medical device and submit a variati…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
The registration application must state the UDI number (e.g. GS1) where one applies to the device
BoMRA's registration guideline requires the 'Device details' part of a medical device registration application to state the UDI number for example a GS1 number, or any other UDI relevant to…
The registration guideline defines the UDI system and the UDI (UDI-DI plus UDI-PI) and refers to IMDRF/WG UDI/N7Final:2013 for the fundamental concepts
BoMRA's registration guideline for medical devices (BOMRA/ER/MED/P04/G01 Iss 3.0, effective 09/12/2024) defines the Unique Device Identification (UDI) system as a system intended to provide…
2 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical evaluation is part of the conformity assessment and a clinical evaluation report is required in the summary technical documentation
Clinical evaluation is part of the conformity assessment procedure for a medical device and is governed by BoMRA's dedicated guidance (BOMRA/ER/MED/P04/G02), which sets out the general prin…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
The Authority may exempt a medicine, and therefore a medical device, from the registration requirement in special circumstances
MRSA 2013 s.23(3)(a) gives the Authority power to exempt in writing any medicine or cosmetic from the registration requirement in special circumstances; because 'medicine' includes any medi…
An exemption from registration is valid for six months
Where BoMRA finds that a product complies with all the requirements for safety, quality and performance it will be exempted and listed, and an approval letter issued to the applicant. The v…
2 source-linked facts
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
The manufacturer must operate a post-market surveillance process and submit PMS reports as a condition of registration
The manufacturer must, prior to and after placing the product on the market, put in place a process as part of its quality management system to assess continued conformity of the device to…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Medical device adverse events must be reported to BoMRA within 48 hours (serious public health threat), 10 days (death or serious adverse event) or 30 days (other events)
It is the responsibility of all manufacturers and healthcare professionals to report medical device adverse events (MDAEs), with importers and distributors forwarding incident reports to th…
1 source-linked fact
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
The authorisation holder must recall on a safety, efficacy or quality problem, and the Authority may recall without prior consultation
Where the holder of a market authorisation becomes aware of a safety, efficacy or quality problem that could have detrimental effects on public health, the holder must, in consultation with…
Recalls are classified as Class I, II or III by degree of health hazard
BoMRA classifies recalls relative to the degree of health hazard presented by the product being recalled. Class I is for defective, dangerous or potentially life threatening products that p…
2 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Only products registered with BoMRA may be advertised, under an advertising control whose scope expressly includes medical devices
BoMRA's Guideline on Advertisement and Promotion of Medical Products (BOMRA/PCT/PMS/P02/G01 Iss 2, effective 15 08 2020) states in its scope that it provides guidance on the requirements fo…
Advertising and promotional material for products including medical devices is submitted to BoMRA for assessment, with a per-product approval fee
BoMRA's Guideline on Advertisement and Promotion of Medical Products (BOMRA/PCT/PMS/P02/G01 Iss 2, effective 15 08 2020), whose scope expressly includes medical devices, sets out how advert…
2 source-linked facts
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
An aggrieved applicant may make written representations to BoMRA and follow the statutory appeal process
Any person aggrieved by a decision of the Authority on an application for registration of a medical device may make representations in writing to BoMRA and follow the appeal process stipula…
1 source-linked fact
Checked 2026-09-16
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Registration timeline

Full registration timeline →

Botswana Medicines Regulatory Authority (BoMRA) review clocks and planning ranges · 4-class (A, B, C and D) for medical devices excluding IVDs under BOMRA/ER/MED/P04/G05, and a separate 4-class (A, B, C and D) individual/public-health-risk axis for IVDs under BOMRA/ER/MED/P04/G06 — both GHTF/IMDRF-derived classification

Class / pathwayReview clockPlanning totalProvenance
Screening — all registration routes (Notification, Class A and B, Class C, Class D)(Application for screening lodged with the applicable screening fee through the BRIMS Self Service Portal; approval of the screening step is what allows the applicant to submit the evaluation application)1-3 months2-5 monthsVerified
Abridged evaluation — Class B, C and D (proof of a reference regulatory agency required)(Abridged evaluation route for Class B, C and D, whose dossier must additionally carry proof of the Reference Regulatory Agency and proof of that agency's marketing authorisation)4-8 months8-14 monthsVerified
Full evaluation — Class B, C and D, local manufacturer(Full evaluation route for a device manufactured in Botswana, with the complete Summary Technical Documentation dossier under G01 ss.6-8)6-10 months10-16 monthsVerified
Full evaluation — Class B, C and D, foreign manufacturer(Full evaluation route for a device manufactured outside Botswana, filed through a Local Technical Representative and submitted electronically through the BRIMS Self Service Portal)8-12 months1-1.7 yearsVerified
3 more pathways on the full timeline · 7 of 7 clocks source-linked
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(1-3 months)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 16 Botswana regulations →

Official BoMRA rules and guidance · 16 of 16 documents linked to official sources

BOMRA/ER/MED/P04/G06Guideline for In Vitro Diagnostic (IVD) Medical Devices Classification
ClassificationVerified
BOMRA/ER/MED/P04/G05Guideline for Medical Devices Classification
ClassificationVerified
BOMRA/ER/MED/P04/G02Guidance on Clinical Evaluation of Medical Devices including IVDs
Clinical TrialsVerified
BOMRA/ER/MED/P04/G04Guideline for Essential Principles Applicable to Medical Devices
GeneralVerified
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