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BoMRA · structured requirements

🇧🇼 Botswana medical device regulatory data

Explore the medical device requirements currently available for Botswana, organized by topic and linked to official sources.

56 facts25 dimensions23 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Only products registered with BoMRA may be advertised, under an advertising control whose scope expressly includes medical devices

advertising.promotion-of-an-unregistered-device-is-prohibited-but-no-device-specific-advertising-approval-was-found
Fact-level verified

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 for the advertising and promotion of 'medical products including medicines, complementary medicines, medical devices, cosmetics, and veterinary medicines in Botswana', and within it the clause 'Products Allowed To Be Advertised' provides that only products that are registered with BoMRA can be advertised. Advertising or promoting an unregistered medical device in Botswana is therefore outside what that advertising control permits. The guideline records the legal basis of the control as s. 46(1)-(4) of the Medicines and Related Substances Act 2013 and Regulation 53 of the Medicines and Related Substances Regulations; its definition of 'Related substance' includes medical devices, and its definition of 'Product' reaches 'related substances'.

Conditions
  • Device coverage rests on the guideline's own text: s. 2.1 names medical devices in the scope, and s. 3.1.5 defines 'Related substance' to include medical devices (which s. 3.1.14 'Product' incorporates).
  • The guideline is an in-force guidance document at Iss 2 (effective 15-08-2020). The Medicines and Related Substances Act, 2025 (assented 24.12.2025), which would carry the advertising control in its Part XVI (s. 83), records 'Date of commencement: ON NOTICE' and so is not in force today; the 2013 Act and this guideline remain operative.
  • The draft Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 would introduce advertising-related fees, but they are not in force; the fees in force are those in the guideline's s. 4.10 under the MRS Regulations 2019.
  • 'Medical representative' is defined in MRSA 2013 s. 2 as a person who promotes, markets or advertises medicines (carried over from the earlier session's reading of the Act).

Effective from 2020-08-15

What is verified now that the earlier session could not: the earlier session could quote only an OCR pass over the Act and searched only BOMRA's device-specific guidelines for an advertising rule, which is why the row ended source-backed-partial. The advertising control is not in the device guidelines at all - it is a cross-cutting Pharmacovigilance guideline, BOMRA/PCT/PMS/P02/G01 Iss 2, which is text-extractable, in force, and names medical devices in its own scope; its registration gate for advertising is quoted verbatim below. The earlier session's positive finding is preserved: the statutory prohibition in MRSA 2013 s. 23(1)(a)-(h) ('No person shall - ... (f) promote; (g) advertise; ... any medicine or cosmetic, unless the medicine or cosmetic is registered by the Authority') remains the primary prohibition, but it is not quoted here because BoMRA's posted copy of the Act is an image-only scan (36 pages, Konica Minolta KM_C224e capture, no embedded fonts) and OCR is not authorised for this corpus - so the readable, device-inclusive guideline is cited instead and the statutory text is recorded in this note only. The earlier absence finding - that BOMRA's device-specific guidelines (registration, labelling, exemption, retention, grouping, clinical evaluation, essential principles) contain no advertising or promotional-material approval clause - still holds and was re-checked for BOMRA/ER/MED/P04/G01 and G03 (zero occurrences of 'advert'/'promot' in either); it is superseded only in the sense that the approval requirement exists elsewhere, and is filed as the separate fact 'advertising.promotional-material-approval-required-with-per-product-fee'. The stale tail of this fact's key ('...-but-no-device-specific-advertising-approval-was-found') is retained only because the importer preserves the existing key; it is corrected by that new fact. Source language is English; passage quoted verbatim below, with '[...]' marking each point at which the PDF's diagonal 'Uncontrolled if printed or downloaded' watermark and the running header interleave characters into the extracted text layer (the extraction prints, in order, '2.1 / p The document provides guidance ... medical devices, 2.2 cosmetics, and veterinary medicines in Botswana.' and '4.1.3 Products Allowed To Be Advertised ir n p a) Only products that are registered with Botswana Medicines Regulatory Authority / (BOMRA) can be advertised.'). Every word between the markers is a contiguous run of that layer; only the interleaved watermark and header characters are elided, and no word of the guideline is changed.

Advertising and promotional material for products including medical devices is submitted to BoMRA for assessment, with a per-product approval fee

advertising.promotional-material-approval-required-with-per-product-fee
Fact-level verified

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 advertising and promotional material is submitted to BoMRA for assessment: the applicant completes Service Request Form BOMRA-QM-P09-F01, submits it to the Finance and Administration office so that a proforma invoice is raised and pays for the advertising material to obtain proof of payment, then submits the advertising material, a cover letter and the proof of payment at the Records Unit; the cover letter must clearly state the product name(s), the registration number(s) and the type of advertisement being submitted for assessment. The guideline fixes the fee payable under the MRS Regulations 2019 for an 'Application for approval of advertisement or promotional material per product': print media P500 and electronic media P1000. The only product class the guideline allows to be advertised 'without seeking prior approval' is registered or cleared cosmetics, and veterinary medicinal products must be submitted to BOMRA for approval.

Conditions
  • Device coverage is by the guideline's scope (s. 2.1 names medical devices) and by s. 3.1.5, which defines 'Related substance' to include medical devices.
  • The guideline is guidance, not the regulation itself: it records its legal basis as s. 46(1)-(4) of the Medicines and Related Substances Act 2013 and Regulation 53 of the Medicines and Related Substances Regulations, and it states the fees as being 'according to the MRSA Regulation 2019'.
  • The guideline gives an express prior-approval exemption only for registered/cleared cosmetics (s. 4.7) and an express submission duty for veterinary medicinal products (s. 4.8); it does not name a separate device-only form, and the fee is levied per product rather than per device class.
  • The Medicines and Related Substances Act, 2025 would replace this with a statutory authorisation requirement and a fine of up to P1 000 000 (Part XVI, s. 83), but its commencement is 'ON NOTICE' and it is not in force today.

Effective from 2020-08-15

CONTRADICTION AND ADJUDICATION. The existing D24 row refreshed above asserts that 'no device-specific advertising or promotional-material approval requirement was found in BoMRA's device guidelines', and the round-204 unresolved map repeated that no device-specific advertising control was located. That is contradicted by BOMRA/PCT/PMS/P02/G01 Iss 2, which operates exactly such a control and names medical devices in its scope. Adjudication: the earlier session searched BOMRA's device-specific guidelines by topic and the Customer Service Standards, and correctly reported that the advertising-approval service times sit in the medicines panels of that document; it did not search the cross-cutting Pharmacovigilance guidelines, where the control actually sits (the title uses 'Medical Products' rather than 'Medical Devices', which is why a device-scoped search missed it). Because the new claim ('an approval requirement for advertising material exists and covers devices') contradicts a stated absence in the existing row, it is filed under a new key rather than folded into it, so the earlier finding is not silently overwritten. Bounded to what the passages say: the guideline requires submission of material to BoMRA for assessment and charges the approval fee, and it exempts only cosmetics from seeking prior approval; it is a guideline, and the underlying statutory power is cited by the guideline itself as MRSA 2013 s. 46(1)-(4) and MRS Regulations Regulation 53. The underlying statute is not quoted here because BoMRA's posted copy of the Act is an image-only scan and OCR is not authorised for this corpus. Source language is English; passage quoted verbatim below, where '[...]' marks points at which the PDF's diagonal 'Uncontrolled if printed or downloaded' watermark and the page header interrupt the text - each fragment between the markers is contiguous in the source.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Annual retention is required to keep a device on the register, and failure removes it

validity.annual-retention-fee-and-reporting-required
Fact-level verified

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 prescribed fee, and BoMRA's retention guideline defines retention as the annual process of maintaining a listed and/or registered medical device on the register by paying the applicable annual fee and submitting any additional product information the Authority prescribes.

Conditions
  • Retention is not the same as renewal: retention keeps the product on the register annually, renewal extends the registration term.
  • The guideline does not apply to devices removed from the register for quality, safety or efficacy reasons.

Effective from 2024-12-01

Guideline BOMRA/ER/MED/P10/G01 Iss 1.0, effective 01/12/2024; read from the OCR pass over BoMRA's scanned copy. The statutory hook is MRSA 2013 s.24(4). BoMRA's device strategy states that annual retention fees must be paid for both listed and registered devices and that failure by the anniversary date results in immediate removal from the register.

Device registration is valid for five years; renewal is applied for six months before expiry

validity.five-year-registration-term-and-six-month-renewal-window
Fact-level verified

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 valid for five (5) years unless suspended or revoked by BoMRA or terminated by the registrant, and s. 4.14 requires applications for renewal of registration to be made six (6) months before the expiry of the existing registration. The draft Medical Devices Regulations, 2026 (reg. 20) would place the same five-year term and six-month renewal window on a statutory footing, but the draft is unpublished and not in force.

Conditions
  • The five-year term is currently a guideline term (G01 s. 4.10); the Medicines and Related Substances Act 2013 s. 24 states no term, and the 2025 Act (commencement on notice) and the draft 2026 Regulations are not in force.
  • Retention on the register is annual and subject to the retention fee (G01 s. 4.10 read with the retention guideline).

Re-issued by the reviewing session after the round-209 fact 'validity-five-year-registration-term-only-in-the-draft-regulations' was found to contradict the in-force guideline.

A renewal application must be made six months before the registration expires, failing which the certificate becomes invalid

validity.renewal-application-six-months-before-expiry
Fact-level verified

Applications for renewal of a device registration must be made six months before the expiry of the existing registration, submitting all applicable renewal requirements. If the registration certificate is not renewed after the expiry date it becomes invalid and the marketing authorisation is terminated.

Conditions
  • The registration certificate carries conditions including payment of annual retention fees, submission of post-marketing surveillance reports and submission of adverse effect reports (s. 4.10).

Effective from 2024-12-09

The in-force guidance does not state the certificate's term; a five-year term appears only in the draft 2026 Regulations (see the registration-term fact).

Authority & regime

Which authority and binding regime govern this product, task, and date?

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BoMRA is the competent authority for medical devices, which it regulates as 'medicines' under the MRSA 2013

authority.bomra-regulates-medical-devices-through-the-medicine-definition
Fact-level verified

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 device statute: section 2 defines 'medicine' to include '(g) any medical device', and defines 'medical device' separately, so the Act's registration, import, distribution and post-market machinery applies to devices. BoMRA operates a dedicated Medical Devices Unit within the Department of Product Evaluation and Registration.

Conditions
  • BoMRA is named as the Authority in the MRSA 2013; the Act is cited by BoMRA's own device guidelines as their legal basis.
  • The Medicines and Related Substances Act, 2025 continues the same Authority but is not yet in force (see the legal-basis facts).

Effective from 2013-01-01

Text read from an OCR pass over BoMRA's scanned copy (download/110/mrs-act/25718/medicines-and-related-substances-act-2013.pdf); OCR artefacts removed from the excerpt without altering wording. The Act has no separate medical-device statute, so the device regime is parasitic on the 'medicine' definition. effectiveFrom is the year of enactment; no day-level commencement date is stated on the published copy.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Significant changes require a variation application; fundamental changes require a new dossier

change.variation-application-for-significant-changes
Fact-level verified

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 variation application under the Medical Devices Variation Guidelines (BOMRA/ER/MED/P09/G01). Changes so fundamental that they alter the terms of the registered device cannot be handled as a change and require a new dossier; any other change must be notified to the Authority immediately.

Conditions
  • The referenced variation guideline was not located on BoMRA's site, so the types of change and the required documents could not be evidenced.
  • BoMRA's device strategy records variations as 'In Effect' from April 2025.

Effective from 2024-12-09

The variation guideline BOMRA/ER/MED/P09/G01 is referenced by the registration guideline but was not found published in BoMRA's document listing. Variation target times are published in the same guideline's timelines table (major 3 months, minor 3 months, notification 1 month).

Classification rules

What local class follows from which rules and decisive product facts?

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General medical devices are assigned to four risk classes, Class A (lowest) to Class D (highest)

classification.four-risk-classes-a-to-d
Fact-level verified

BoMRA classifies general medical devices into four classes: Class A (low risk/hazard), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk). Classification is rule-based, derived from the GHTF/IMDRF-style rules, and where more than one rule applies the device is allocated the highest level of classification indicated.

Conditions
  • Class A devices, and other notifiable devices, use the notification pathway under BOMRA/ER/MED/P04/G08 (referenced by the registration guideline; that guideline was not found published on the BoMRA site).

Effective from 2023-04-01

Class A is handled through the notification pathway rather than the registration guideline (BOMRA/ER/MED/P04/G01 applies to Classes B, C and D only).

IVD medical devices use a separate four-class risk system, Class A to Class D

classification.ivd-four-class-risk-system
Fact-level verified

IVDs are classified under their own four-class system in Table 1 of BOMRA/ER/MED/P04/G06: Class A (low individual and low public health risk), Class B (moderate individual and/or low public health risk), Class C (high individual and/or moderate public health risk) and Class D (high individual and high public health risk), with classification driven by the device's intended use and the applicable IVD rules.

Effective from 2023-04-01

Where more than one IVD rule applies, the device is allocated to the highest class indicated (e.g. self-testing for HIV is class D under rule 1, not class C under rule 4).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evaluation is part of the conformity assessment and a clinical evaluation report is required in the summary technical documentation

clinical.clinical-evaluation-report-required-and-governed-by-dedicated-guidance
Fact-level verified

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 principle, the sources of clinical data, appraisal and analysis of clinical data, and the clinical evaluation report. The summary technical documentation for a Class B, C or D device must include pre-clinical studies where applicable and the clinical evaluation report summarised per the current IMDRF guidance documents.

Conditions
  • The clinical evaluation guideline's table of contents includes a dedicated Clinical Evaluation Report section (s. 8) and Template I.
  • BoMRA's device strategy lists 'Clinical Trial (CT) Plans: structured oversight for all device investigations' as a 2026-2030 programme to be developed.

Effective from 2022-04-01

The report requirement itself is verified in the registration guideline at s. 6.9 ('The clinical evaluation report should be summarized as per the current IMDRF guidance documents'); the clinical-evaluation guideline is cited here for the governing procedure. Clinical Investigation is defined in the registration guideline at s. 3.1.6 as 'any designed and planned systematic study in human or animal subjects undertaken to verify performance of a specific device'.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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In-vitro diagnostic medical devices are regulated inside the medical device framework, with separate classification and registration guidelines

scope.ivd-regulated-within-the-device-framework
Fact-level verified

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 diagnostic medical devices', and separate IVD-specific instruments exist for classification (BOMRA/ER/MED/P04/G06) and registration (BOMRA/ER/MED/P04/G09).

Conditions
  • The registration guideline for general devices expressly excludes IVDs from its scope; IVDs use BOMRA/ER/MED/P04/G09.

Effective from 2023-04-01

The MRSA 2013 section 2 definition of 'medical device' does not itself name IVD reagents, but BoMRA's guidelines and registers treat IVDs as medical devices.

The device definition in force is the MRSA 2013 section 2 definition

scope.medical-device-definition-in-force
Fact-level verified

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 article used in the diagnosis, mitigation, treatment or prevention of disease in man or animals, or used to affect the structure or function of the body of man or animals, and not achieving its principal intended purposes through chemical action in the body or by being metabolised.

Conditions
  • A broader definition (including in-vitro re-agents, calibrators and software, with the GHTF/IMDRF structure) appears in the draft 2026 Regulations and is not yet in force.
  • BoMRA's device guidelines use the same working definition, e.g. the Retention Guideline defines 'medical devices' identically.

Effective from 2013-01-01

OCR pass over BoMRA's scanned copy; wording unchanged.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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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

dossier.class-b-c-d-dossier-contents
Fact-level verified

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 the online platform; letter of authorisation; proof of a quality management system such as an ISO 13485 certificate or equivalent; information on device details; summary technical documentation; labelling information; and the Essential Principles checklist. Failure to arrange the dossier in that order may lead to rejection at submission.

Conditions
  • The summary technical documentation must include the device description and features, evidence of conformity to the Essential Principles, materials, and (where applicable) pre-clinical studies and a clinical evaluation report.
  • Each application must contain exactly one grouping: a single device, a device family, a device system or a device group.

Effective from 2024-12-09

Class A devices and notifiable devices are covered by the notification guideline instead.

Each registration application may contain only one grouping of medical devices

dossier.one-grouping-per-application
Fact-level verified

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/MED/P04/G07, which applies to all medical devices including IVDs.

Conditions
  • Grouping affects the fee: the draft 2026 Fees Regulations provide grouped-application discounts for variants of the same device family at the same manufacturing site with the same intended use and risk classification.

Effective from 2024-12-09

Restated in the registration guideline at s. 4.6.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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An application for registration must be made by a company registered, licensed or operating in Botswana

operator.applicant-must-be-a-company-registered-in-botswana
Fact-level verified

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.

Conditions
  • Because 'medicine' includes any medical device (s. 2), this applicant restriction reaches device registration.
  • BoMRA's device guidance implements it through the Local Technical Representative requirement.

Effective from 2013-01-01

OCR pass over BoMRA's scanned copy; wording unchanged. The section heading in the gazetted text is 'Application for registration'.

A non-resident applicant must appoint a Local Technical Representative (Authorized Representative) resident or incorporated in Botswana

operator.local-technical-representative-required
Fact-level verified

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 representative is the applicant for BoMRA purposes and takes responsibility for compliance with Botswana law. The draft 2026 Regulations would put the same obligation on a statutory footing under section 36 of the 2025 Act.

Conditions
  • The LTR, not the foreign manufacturer, is the applicant of record.
  • The requirement applies to both general medical devices and IVDs.

Effective from 2024-12-09

The same requirement is restated in BoMRA's device strategy: 'If Applicant is not a Local Entity, a Local Technical Representative (LTR) need to be appointed.' The draft 2026 Regulations, reg. 10(1), would require the LTR to be 'resident or incorporated in Botswana' under s. 36 of the 2025 Act, but that is not yet in force.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Local device establishments moved from listing to formal licensing on 1 April 2025

establishment.licensing-of-device-establishments-from-april-2025
Fact-level verified

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 licence, and from the same date mandatory permits and import fees are required for every consignment of medical devices and IVDs entering or leaving Botswana via the BRIMS portal.

Conditions
  • Establishment licensing is a local-entity obligation and is separate from product registration.

Effective from 2025-04-01

BoMRA's own Medical Devices including IVDs Regulatory Update. effectiveFrom uses the date BoMRA states in the document.

Named non-medical and general-purpose categories are outside BoMRA's import-control scope and need no permit, clearance or registration

import.categories-outside-regulatory-scope-need-no-clearance
Fact-level verified

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-use PPE, external quality assessment and proficiency testing materials, general non-clinical laboratory equipment, devices solely for academic or experimental use, medical training equipment and simulators, general wellness and fitness devices not intended for clinical diagnosis, breathalysers and screening equipment not intended for clinical diagnostic procedures, spare parts and accessories for repairing existing equipment, and forensic/law-enforcement test kits.

Conditions
  • A smartwatch or fitness tracker positioned for clinical diagnosis, disease prevention or hospital treatment is not covered by the wellness carve-out.
  • Spare parts are carved out only when imported for the repair or servicing of existing equipment.

Effective from 2026-09-04

BoMRA states this reflects 'the current phase of regulatory implementation' and reserves the right to bring any of these categories into active oversight later, with changes communicated by official public notice before enforcement.

Both product registration and an import licence are mandatory to import medical devices

import.registration-and-import-licence-required-for-import
Fact-level verified

BoMRA states that for the import of medical devices into Botswana, registration of the product and an import licence are mandatory, and that the main requirements for import or export control include identification of a local representative, a market authorisation certificate from the country of origin, an import/export licence from BoMRA (or an import licence from the competent authority in the importing country), and registration of the product.

Conditions
  • A 'market authorisation certificate from the country of origin' is an import-control requirement, not a recognition route: it is demanded as paperwork and does not shorten BoMRA's own evaluation.
  • The import permit regime moved onto the BRIMS portal with mandatory permits and import fees for every consignment from 1 April 2025 (see the establishment-licensing fact).

Effective from 2021-12-22

Guideline BOMRA/IL/IE/P02/G03 Iss 1.0, effective 22-12-2021. BoMRA's site also serves a later 'Iss 2.0' file of the same title; the Iss 1.0 text layer was readable and is cited here. The guideline's own legal-basis section cites MRSA 2013 and the MRSR 2019, i.e. the regime in force.

Fees

What regulator fee applies to this class, route, event, and date?

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Listed and registered devices are retained annually against an applicable annual fee quoted through the BRIMS portal; no amount is published

fees.annual-retention-fee-quoted-through-brims
Fact-level verified

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 information BoMRA prescribes. The guideline grounds the duty in the MRSA 2013 requirement to submit information annually accompanied by a retention fee, and runs the process on the BRIMS self-service portal, where a quotation is generated and the product is retained once the fee is paid.

Conditions
  • No fee amount appears in the guideline, its Annexure 1 spreadsheet (BOMRA/ER/MED/P10/F01, read in full) or BoMRA's December 2023 retention circular, which lists medicine amounts only.
  • The draft 2026 Fees, Levies and Penalties Regulations would set an annual retention fee of USD 1,500 for international applicants (already recorded as draft).

Effective from 2024-12-01

The flow chart at s. 5 shows 'Quotation Generation' then 'Fee paid' then 'Product Retained' after a 10-day verification step.

The draft 2026 Fees Regulations set differentiated device registration fees by risk class

fees.draft-2026-device-registration-fees
Fact-level verified

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 applicants (in USD) and local applicants (in BWP). For international applicants the draft Schedule 4.3 lists Class A and notifiable USD 185, Class B USD 1,110 and Class C and D USD 1,555, with an annual retention fee for all products of USD 1,500 and variation fees of USD 225 (major), USD 150 (minor) and USD 75 (notification).

Conditions
  • These fees are NOT in force: the draft carries a blank making date and BoMRA's press release of 31 August 2026 describes the Fees, Levies and Penalties Regulations as still in draft and open for stakeholder input.
  • A separate draft Schedule 4.4 gives the local-applicant fees in BWP (e.g. Class B fully manufactured in Botswana BWP 8,600; Classes C and D fully manufactured in Botswana BWP 10,300), with an annual retention fee of BWP 1,500.

Verified against the PDF text layer of the draft. Regulation 12(2) of the same draft states fees are differentiated by risk classification: Class A notification pathway fees, Class B standard evaluation fees, Class C enhanced evaluation fees and Class D full evaluation fees.

Import/export control fees for devices: P50 per import/export permit application, P100 per transit permit, and an importation fee of 0.15% of consignment value

fees.import-export-permit-fees-for-medical-devices
Fact-level verified

BoMRA's import/export guideline lists the paid services of the import-export control unit for medical devices: application to import/export medical devices P50; application for a transit permit P100; and an importation fee of 0.15% of the value of the consignment for all other products. The importation fee is invoiced from the supplier's invoice after the consignment arrives, paid against a sales order, and proof of payment is required before a subsequent permit is issued.

Conditions
  • Amounts derive from the Medicines and Related Substances Regulations 2019 fee schedule (Schedule 5: 'Application to import/export for all products excluding narcotics... 50 per permit'; 'Application for Transit Permit 100 per permit'; 'Importation fee for all other products 0.15% of the value of the consignment'), applied to devices by this guideline.
  • The line 'Application to vary an import/export permit of medical devices' prints as '00' in the PDF text layer; the 2019 schedule charges P100 only for varying narcotics/psychotropics permits, so the device variation fee is read as nil but is not legible enough to assert.
  • These are the only device-applicable fee amounts in force; registration, screening, evaluation and retention amounts for devices are not in the 2019 schedule.

Effective from 2021-12-22

Section 8.5.1 (numbered out of sequence in the source) records that BoMRA introduced paid regulatory processes from February 2020 under the MRSA 2013 and the 2019 Regulations. The table's page break falls between the transit-permit row and the header block; rows transcribed exactly.

Every device application must carry the fee in the Fees and Charges Regulations in force; screening and evaluation fees are paid at lodging, unpaid applications are not accepted, and fees are non-refundable

fees.screening-and-evaluation-fees-at-lodging-non-refundable
Fact-level verified

Every application must be accompanied by the appropriate fees specified in the Fees and Charges Regulations (Schedule 5 of the Medicines and Related Substances Regulations 2019) in force at the time of application. Screening fees are paid when the application is lodged for screening and evaluation fees when it is lodged for evaluation; an application not accompanied by the appropriate fees is not accepted, and all fees are non-refundable once paid.

Conditions
  • The referenced 2019 Schedule 5 contains no medical-device fee head (already recorded), so the amounts BoMRA actually quotes for device screening and evaluation are not published in an in-force instrument; the draft 2026 Fees, Levies and Penalties Regulations would supply them.
  • Processing timelines start only once the application is accepted and the screening/evaluation fee is paid (ss. 4.9(i) and (vi)).

Effective from 2024-12-09

The IVD registration guideline carries the same clause.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Product labelling must be in English

label.english-required
Fact-level verified

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.

Conditions
  • The requirement is English only; no second official language is required on the label.
  • Labelling information is a mandatory element of the Class B, C and D dossier (reg. guideline s. 4.7.2(vi)).

Effective from 2022-04-01

Guideline BOMRA/ER/MED/P04/G03 Iss 1.0. A general translation rule also applies across BoMRA's device instruments: any application document not written in English must be accompanied by a verified English translation (stated in the exemption guideline at s. 5.7 and the exemption revision sheet).

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

The manufacturer must operate a post-market surveillance process and submit PMS reports as a condition of registration

pms.post-market-surveillance-plan-and-reporting-conditions
Fact-level verified

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 the Essential Principles through the post-marketing phase, covering complaint handling, post-market vigilance reporting, and corrective and preventive actions. Submission of post-marketing surveillance reports is also an express condition of the registration certificate.

Conditions
  • A Post Marketing Surveillance Plan is a mandatory component of the Class B, C and D application per the application requirements table.
  • BoMRA's device strategy lists 'National PMS & Vigilance: systematic field sampling and adverse event reporting' as a 2026-2030 programme.

Effective from 2024-12-09

The registration certificate conditions at s. 4.10 read: 'a) Payment of annual retention fees as prescribed in the current Fees and Charges Regulations in force. b) Submission of post-marketing surveillance reports. c) Submission of adverse effect reports associated with the use of device. d) And any other conditions will be set in the registration certificate.'

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Registration dossiers must be submitted electronically through the BRIMS Self Service Portal

forms.submission-through-brims-online-portal
Fact-level verified

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.bw/. BoMRA's strategy confirms registration is done via BRIMS and that import/export permits are also lodged there.

Conditions
  • The paper application form is no longer the entry point: the application form itself is completed 'on the online platform'.
  • BoMRA also publishes the applicable forms and templates as annexures to its device guidelines (e.g. the listing and retention forms and the exemption application form).

Effective from 2024-12-09

The same portal is named in BoMRA's device strategy for import/export permits.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

Proof of an ISO 13485 or equivalent quality management system certificate is a mandatory dossier item

qms.iso-13485-proof-required-in-the-dossier
Fact-level verified

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. The abridged pathway additionally conditions eligibility on a 'valid ISO 13485 certification or equivalent'.

Conditions
  • BoMRA's GMP recognition guideline governs whether a site inspection is needed; the dossier requirement for a QMS certificate is separate from that.
  • The draft 2026 Regulations would allow reliance on ISO 13485 certification for Class B, C and D and on MDSAP audit outcomes, but are not in force.

Effective from 2024-12-09

For the exemption pathway the equivalent evidence is 'a copy of a manufacturing license and/or ISO 13485 certificate or Business license or any proof of manufacturer's registration in the respective authorities', which must be issued by a recognised conformity assessment body (exemption guideline s. 5.4.1).

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

The authorisation holder must recall on a safety, efficacy or quality problem, and the Authority may recall without prior consultation

recall.recall-duty-on-the-authorisation-holder-and-independent-power-of-the-authority
Fact-level verified

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 the Authority, recall the medicine (and therefore the device). Contravention is an offence. The Authority may also recall a medicine or cosmetic without prior consultation with the authorisation holder.

Conditions
  • The registration guideline adds that BoMRA may give reasons in writing to suspend or revoke a registration or amend its conditions, and that the applicant may terminate registration or withdraw the marketing authorisation per the withdrawal guidelines (s. 4.11).

Effective from 2013-01-01

OCR pass over BoMRA's scanned copy; wording unchanged. The provision reaches devices through the section 2 definition of 'medicine'.

Recalls are classified as Class I, II or III by degree of health hazard

recall.three-class-recall-scheme
Fact-level verified

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 predictably or probably could result in serious health risk, adverse events or death; Class II is for products that possibly could cause a temporary or medically reversible adverse health problem or mistreatment; and Class III is for products that are defective and unlikely to cause any adverse health reaction, or which do not comply with the requirements of the Medicines and Related Substances Act 2013 as to printed packaging material, product specification, labelling and the like.

Conditions
  • A health hazard evaluation and a recall strategy are part of the procedure (ss. 4.7-4.8).

Effective from 2022-11-29

Guideline BOMRA/PCT/PMS/P01/G01 Iss 2, effective 29-11-2022. Causes enumerated at s. 4.2 include incorrect or inappropriate labelling, contamination, unfavourable stability results, and quality not meeting specifications including efficacy.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Class B, C and D devices register through either full evaluation or abridged assessment

registration.full-and-abridged-assessment-pathways
Fact-level verified

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 from any SRA or RRA, is novel, is not identical to a device already registered in Botswana, or does not meet the abridged criteria. Abridged assessment applies where the device already holds approval from a reference or stringent authority (see the reliance facts). Class A and other notifiable devices go through a separate notification pathway.

Conditions
  • Class A and notifiable devices are out of scope of BOMRA/ER/MED/P04/G01 and use the notification guideline BOMRA/ER/MED/P04/G08, which was not found published on the BoMRA site.
  • The registration guideline applies only to Classes B, C and D general medical devices; IVDs use BOMRA/ER/MED/P04/G09.

Effective from 2024-12-09

The abridged pathway's eligibility conditions are set out separately in the reliance-recognition facts. A third pathway, expedited review, appears in the timelines table (s. 4.15).

IVD medical devices in Class B, C and D register through abridged or full assessment pathways

registration.ivd-registration-pathways
Fact-level verified

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 applies to all Class B, C and D IVD medical devices. Class A IVDs go through the notification guideline instead.

Effective from 2024-12-09

The IVD guideline shares the numbering and the timelines table of the general-device guideline (s. 4.14 renewals, s. 4.15 registration timelines).

Registration is being phased in by risk class, with Class C and D devices facing a 30 June 2026 mandatory deadline

registration.mandatory-registration-deadlines-by-class
Fact-level verified

BoMRA's device strategy sets out a phased move from listing to mandatory registration: Class C and D registration opened in April 2024 with a mandatory deadline of 30 June 2026; Class B opened on 1 April 2026 with a deadline of 31 March 2027; Class A (notification) opens on 1 October 2026 with a deadline of 30 September 2027. Once a deadline passes, the device is removed from the Listing Register and must be on the Registration Register.

Conditions
  • Listing under the Listing Register is a legacy pre-registration mechanism (Guideline for Listing of Medical Devices, BOMRA/ER/MED/P02/G01) that is being superseded by registration.
  • The strategy also records BoMRA as an IMDRF Affiliate Member (September 2024) and a GHWP Full Member (December 2024).

BoMRA publication 'BOMRA Medical Devices including IVDs Regulatory Update', authored by the Head of the Medical Devices Unit; it is BoMRA's own strategy document, not third-party commentary.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Botswana approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Botswana (13 records)

BotswanaIMDRF member authorities · WHO · MDSAP

Prior approval / evidence record

The broad reliance and mutual-recognition provisions in the 2025 Act and the draft 2026 Regulations are not yet an operating route

reliance.draft-2026-regulations-reliance-provisions-not-in-force
Fact-level verified
Statement

The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The document is an unpublished draft: its cover reads '(Published on __________, 2026)' and the companion Fees Regulations read 'Made this ___ day of ___, 2026'.
  • BoMRA's press release of 31 August 2026 states the regulations are 'both still in draft form and open for stakeholder input'.
  • The 2025 Act on which the draft depends has its commencement 'ON NOTICE'.
  • Draft reg. 17(3) preserves BoMRA's power to request Botswana-specific information, impose local conditions, conduct independent assessment and take independent regulatory action.

Status is official-source-verified for the text of the draft; the conditions and the reliance-recognition value record that the instrument is not in force. This is the deliberate 'do not upgrade a policy aspiration into an operating route' fact for Botswana. The draft would also give registration a five-year term (draft reg. 20(1)).

BotswanaWHO

Prior approval / evidence record

WHO Prequalification (WHO Collaborative Registration Procedure)

Authority

WHO Prequalification (WHO Collaborative Registration Procedure)

Accepted

Yes

Benefit

A dedicated WHO CRP row with a published 3-month target in G01 s.4.15, shorter than any other route; the manufacturer must submit the filled form 2 and form 3 with the application.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway

Prior approval / evidence record

Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)

Authority

Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)

Accepted

No

Benefit

The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaNMPA

Prior approval / evidence record

China NMPA medical device registration certificate

Authority

China NMPA medical device registration certificate

Accepted

No

Benefit

No route. The NMPA is not named among the ICH members, observers or mutual-recognition-associated authorities in G01 s.3.1.26, and G01's device guideline names no recognition procedure for it. An NMPA certificate may be filed where the Authority asks for proof of registration in other countries, but it carries no procedural benefit and does not abridge BoMRA's evaluation.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaSource authority not specified

Prior approval / evidence record

Marketing approval in another SADC state (ZAMRA, SAHPRA, PPB, TMDA)

Authority

Marketing approval in another SADC state (ZAMRA, SAHPRA, PPB, TMDA)

Accepted

No

Benefit

No abridgement. SADC and ZAZIBONA procedures cover medicines, not devices, and there is no regional device approval; a SADC registration is not among the Reference Regulatory Authority requirements BoMRA's device guideline states, so it does not shorten the Botswana route.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

BotswanaNMPA

Prior approval / evidence record

China NMPA approval is accepted only for Class A and Class B medical devices

reliance.china-nmpa-recognition-limited-to-class-a-and-b
Fact-level verified
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 Class B medical devices; the same limitation is applied to SAHPRA. China NMPA is not a Stringent Regulatory Authority under BoMRA's SRA definition and so cannot ground the Class C or Class D abridged criteria.

Source Approval

China National Medical Products Administration (NMPA) marketing authorisation - Class A and Class B medical devices only

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Limited to the exemption pathway; the abridged registration pathway for Class C and D requires an SRA or an RRA, and NMPA is neither on the published SRA definition.
  • The class limit is Class A and Class B only.
  • Read together with the parent exemption fact, which carries the six-month validity and the requirement that the device not already be on the interim register/listing.

Effective from 2023-04-01

Filed as its own fact because China NMPA is the reference approval the customer question asks about explicitly, and because the class limitation is the actionable part. OCR interleaving of the parenthetical is flagged in the accompanying exemption-route fact. NMPA's absence from the SRA definition is verified separately at s. 3.1.26 of BOMRA/ER/MED/P04/G01.

BotswanaWHO

Prior approval / evidence record

BoMRA's dedicated reliance/recognition guideline on regional and international bodies covers medicines only, not devices

reliance.medicines-reliance-guideline-excludes-medical-devices
Fact-level verified
Statement

BoMRA operates a separate reliance/recognition guideline for regional and international bodies that names reference authorities, ZAZIBONA, WHO Listed Authorities and an AMA continental listing procedure - but its scope is expressly limited to medicines, vaccines, blood and blood products. It creates no medical device route and must not be read as one.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The reference-authority lists in this guideline (including WHO-Listed Authorities and the AMA continental listing procedure) must NOT be upgraded into a device route.
  • Device reliance is instead governed by BOMRA/ER/MED/P04/G01 Table 2 (abridged assessment) and BOMRA/IL/IL/P08/G02 (GMP recognition and reliance).

Effective from 2026-02-16

Filed as no_reliance_route because the fact is a negative: this instrument, which is the one whose title most suggests a device reliance route, does not apply to devices. The document header carries 'Function: Human and Veterinary Medicines', Document No. BOMRA/ER/MD/P04/G07, Issue No. 3.0, effective 16-02-2026. Source read from the OCR pass over BoMRA's scanned copy; the revision sheet records 'Inclusion of AMA Continental Listing procedure' at Issue 2.0.

BotswanaEU conformity assessment · US FDA · Japan MHLW / PMDA · Swissmedic · Health Canada · Australia TGA · Iceland · Norway · WHO

Prior approval / evidence record

A prior approval from an SRA, an RRA, or WHO (with ISO 13485) opens the abridged assessment pathway

reliance.abridged-assessment-on-sra-rra-or-who-approval
Fact-level verified
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 prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.

Source Approval

Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Each class has its own threshold: Class B - one RRA, SRA or WHO approval; Class C - one SRA or WHO approval plus 3 years marketed in an SRA jurisdiction; Class D - two RRAs including one SRA plus 3 years marketed.
  • The three-year safety test is defined as no reported deaths, no reported serious deterioration in the state of health of any person, and no open field safety corrective actions including recalls at the point of submission.
  • A prior rejection or withdrawal by a foreign jurisdiction for quality, performance/efficacy or safety reasons disqualifies the abridged route.
  • The RRA list itself is not published in the guideline; it lives in BOMRA-ER-MED-Policy No.1, which BoMRA's site did not serve.
  • Regulatory layer is premarket_review: the abridged route shortens the assessment, it does not dispense with BoMRA's registration.

Effective from 2024-12-09

SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.

BotswanaSource authority not specified

Prior approval / evidence record

Contraceptive devices registered in any SADC country qualify for abridged assessment

reliance.contraceptive-devices-registered-in-sadc-countries
Fact-level verified
Statement

As a regional concession, abridged assessment is available for contraceptive medical devices that have already been registered in any SADC country, without the SRA or RRA approval that the general abridged criteria otherwise require.

Source Approval

Registration of the contraceptive device by any SADC national regulatory authority (e.g. SAHPRA, MCAZ, ZAMRA, TMDA)

Edge Type

Collaborative Abridged Registration

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The note sits under the Class C abridged criteria and does not state a class limitation; read literally it covers contraceptive devices regardless of class.
  • The provision is confined to contraceptives; it does not create a general SADC-registration route for other devices.

Effective from 2024-12-09

Recorded as a distinct mechanism because the qualifying reference registration is a SADC registration, not an SRA registration. edgeType uses the registry token collaborative_abridged_registration (already in use) rather than abridged_or_recognition_route, because the trigger is a regional registration rather than a stringent-authority approval.

BotswanaWHO

Prior approval / evidence record

WHO prequalification is an accepted reference approval, and WHO CRP has its own 3-month review clock

reliance.who-prequalification-and-who-collaborative-registration
Fact-level verified
Statement

WHO prequalification functions as a reference approval for the abridged pathway (WHO approval with ISO 13485 satisfies the Class B abridged condition, and WHO with ISO 13485 satisfies Class C), and devices entering through the WHO Collaborative Registration Procedure have a published target assessment time of three months.

Source Approval

WHO prequalification (including WHO Collaborative Registration Procedure listings)

Edge Type

International Listing

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • No equivalent WHO CRP row is published for Class D devices.
  • BoMRA's separate medicines-only reliance guideline also lists WHO Listed Authorities and the AMA continental listing procedure, but its scope is medicines, vaccines, blood and blood products (see the medicines-only fact).

Effective from 2024-12-09

The WHO CRP row sits in the general registration guideline's timelines table alongside the notification, abridged and full evaluation rows, which is what shows WHO CRP to be a live route rather than an aspiration. The abridged eligibility rows in Table 2 separately accept 'WHO with ISO 13485 or equivalent' (Class B) and 'WHO with valid ISO 13485 certification or equivalent' (Class C).

BotswanaEU conformity assessment · NMPA · Singapore HSA · WHO

Prior approval / evidence record

An exemption from registration can be granted on production of a marketing authorisation from an RRA or other named authority, a CE certificate from an EU notified body, or a WHO EUL/PQ acceptance letter

reliance.exemption-route-accepts-reference-authority-marketing-authorisation
Fact-level verified
Statement

For devices that are not on the interim register/listing, BoMRA's exemption guideline makes a foreign marketing authorisation a required piece of evidence: a copy or proof of the marketing authorisation issued by a relevant Reference Regulatory Authority, Singapore HSA, China NMPA (Class A and B only) or SAHPRA (Class A and B only), and/or a CE certificate issued by a European notified body under MDD 93/42/EEC, IVDD 98/79/EC, MDR (EU) 2017/745 or IVDR (EU) 2017/746, and/or proof of a WHO EUL or Prequalification acceptance letter. Approval places the device on an exempted list with a six-month validity.

Source Approval

Reference Regulatory Authorities recognised by BoMRA; Singapore Health Sciences Authority; China NMPA (Class A and B only); South African Health Products Regulatory Authority (Class A and B only); CE certificate from a European notified body under MDD/IVDD/MDR/IVDR; WHO EUL or WHO Prequalification acceptance letter

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • s. 5.5.4 adds that for a public health emergency product a valid registration certificate/approval/emergency use authorisation issued by ICH member countries as defined prior to 23 October 2013, or by WHO, must be provided.
  • s. 5.5.5 states that points 5.5.1 to 5.5.4 do not apply to a local manufacturer.
  • The exemption is a limited-duration alternative to registration: s. 7.2 gives the approved product a validity period of six (6) months unless revoked by the Authority or terminated by the applicant.
  • The exemption guideline applies to devices including IVDs that are not included in the interim register/listing.

Effective from 2023-04-01

Excerpt read from the OCR pass over BoMRA's scanned copy (download/98/exemptions/25635/...). In s. 5.5.1 the parenthetical '(Only for Class A & B medical devices)' is interleaved by the PDF's line order and applies to China NMPA and to SAHPRA; the wording has not been altered but the reading is flagged. BoMRA's own revision sheet records the addition of 'China National Medical Products Administration (Only for Class A & B medical devices)' at Issue 3.0 and 'by European notified bodies (Except Class A)' at Issue 2.0.

BotswanaWHO

Prior approval / evidence record

GMP clearance can be granted by desk assessment of inspection reports from WHO-listed authorities, SADC regulators and other authorities

reliance.gmp-inspection-recognition-and-reliance
Fact-level verified
Statement

Separately from the product dossier, BoMRA recognises and relies on GMP inspection outcomes. Under the Guideline for Good Recognition and Reliance Practices it accepts desk-assessment of inspection reports issued by WHO-Listed Authorities, by SADC regulators (SAHPRA, MCAZ, ZAMRA and TMDA) including outcomes from the WHO Prequalification Programme and ZAZIBONA, and by other authorities such as Ghana FDA; it also recognises WHO Prequalification and regional initiatives such as ZAZIBONA and AMA. Facilities approved through those mechanisms may not require an on-site inspection. This abridges the site-inspection step, not the dossier review.

Source Approval

WHO-Listed Authorities; WHO Prequalification Programme; SADC national regulatory authorities (South Africa SAHPRA, Zimbabwe MCAZ, Zambia ZAMRA, Tanzania TMDA); ZAZIBONA; AMA; other authorities such as Ghana FDA

Edge Type

Qms Audit Reliance

Market Access Strength

Evidence Only

Regulatory Layer

Qms Audit

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Recency limits apply: facilities inspected and approved by recognised SADC and other authorities are considered for desk assessment only if the inspection and approval are not older than two (2) years (s. 6.2.5(a)).
  • Validity of GMP clearance granted through desk assessment does not exceed the referenced certificate's validity or two years, whichever is shorter (s. 6.2.7).
  • For facilities outside WLA jurisdictions reliance is capped at two consecutive cycles, after which an on-site inspection is required (s. 6.2.8).
  • BoMRA may still require an on-site or virtual inspection on risk assessment (s. 6.2.3); reliance is unilateral and does not waive its own decision.
  • The guideline's own revision sheet records that the SRA definition was replaced by the WHO Listed Authority definition and that recognition of PIC/S-participating authorities was removed at Issue 1.0.

Effective from 2026-04-23

Recorded as qms_audit_reliance using the registry token already applied to MDSAP/audit-reliance edges, with regulatoryLayer qms_audit and marketAccessStrength evidence_only: the mechanism abridges the site inspection, not the marketing-authorisation review. The guideline's legal-basis section cites MRSA 2025 ss. 7(j), 58 and 109, but its Preamble also states BoMRA 'was established through the Medicines and Related Substances Act of 2013 and continues to operate under provisions of the Medicines and Related Substances Act, 2025'.

BotswanaSource authority not specified

Prior approval / evidence record

A Reference Regulatory Authority (an NRA recognised by BoMRA under its recognition-and-reliance policy) with a marketing authorisation already granted

Authority

A Reference Regulatory Authority (an NRA recognised by BoMRA under its recognition-and-reliance policy) with a marketing authorisation already granted

Accepted

Yes

Benefit

This is the only foreign approval that changes the route: proof of the Reference Regulatory Agency and proof of its marketing authorisation are required dossier items for the abridged pathway (G01 Table 3) and not for the full pathway, and the abridged target is 4-8 months against the full foreign-manufacturer target of 8-12 months. It does not replace BoMRA's own evaluation of the abridged dossier.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

BoMRA publishes target assessment times by pathway and class, from 3 months for WHO CRP to 12 months for full evaluation of a foreign manufacturer's Class D device

review-clocks.registration-timelines-by-pathway-and-class
Fact-level verified

BoMRA's registration guideline publishes target timelines: screening is 3 months for the notification pathway and 1-2 months for Classes A/B, C and D; abridged assessment is 4 months (Class A and B), 6 months (Class C) and 8 months (Class D); full evaluation is 6/8/10 months for a local manufacturer and 8/10/12 months for a foreign manufacturer across Classes A/B, C and D; expedited review is 4/6/8 months; WHO CRP is 3 months; query response 1 month; exemptions 72 hours; major and minor variations 3 months; and notification variations 1 month.

Conditions
  • Applicants get two query cycles; failure to respond within the published timeline is deemed withdrawal of the application.
  • The registration guideline's timelines are target assessment times; the clock stops while a query is outstanding.

Effective from 2024-12-09

BoMRA's Customer Service Standards (BOMRA/CEO/PR/P08/A01 Iss 1.0, dated 11-09-2020) separately state service times for inspections (distributor/retailer new facility 4 weeks, renewal 6 weeks, expedited 2 weeks; local manufacturer 45 days; international manufacturer 100 days) and for import/export permit issuance (48 hours, 24 hours for transit permits), and give 48 hours / 72 hours for medical device exemption from registration in the product-evaluation panel.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

The Authority may exempt a medicine, and therefore a medical device, from the registration requirement in special circumstances

special-access.authority-may-exempt-a-device-from-registration-in-special-circumstances
Fact-level verified

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 medical device, this is the statutory basis for BoMRA's exemption-from-registration guideline, which states in terms that section 23(3), (4) and (5) provides for the Authority to exempt medical devices from registration under special circumstances.

Conditions
  • The exemption is for devices not included in the interim register/listing.
  • s. 23(3)(b) allows the Authority by gazette order to declare a medicine or cosmetic banned, in which case it shall not be registered or its registration cancelled.

Effective from 2023-04-01

Read from the OCR pass over BoMRA's scanned copy. The statutory provision itself was read in the MRSA 2013 OCR at s. 23(3)(a). BoMRA's revision sheet records this clause as added to the exemption guideline at Issue 7.0, 13/03/2023.

An exemption from registration is valid for six months

special-access.exemption-validity-six-months
Fact-level verified

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 validity period of approved products is six months unless revoked by the Authority or terminated by the applicant; the list of approved/exempted devices and applicant details is published on the BoMRA website monthly or as necessary.

Conditions
  • Because the validity is six months, the exemption is a temporary market-entry mechanism, not a substitute for registration.
  • Where an amendment is needed because of an error by the Authority a letter or email suffices; otherwise a new exemption application (with fees where applicable) must be lodged.

Effective from 2023-04-01

Read from the OCR pass over BoMRA's scanned copy. Amendment of an expired exemption letter is not considered; a new application must be lodged (s. 6.5.3). Exemption processing is within three working days of acceptance and payment (s. 6.2).

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Appendix B of the Essential Principles guideline maps ISO/IEC/CLSI standards to each essential-principle section (ISO 13485, 14971, 14155, 10993, IEC 60601, 61010, 62366-1, ISO 11135/11137/11607/17665 and others)

standards.appendix-b-standards-mapped-to-essential-principles
Fact-level verified

Appendix B of BoMRA's Essential Principles guideline is a table of 'Relevant Standards' per essential principle, described as general, non-exhaustive guidance: for 5.1 (general) ISO 13485, ISO 14971, ISO 23640, ISO 24971 and CLSI EP25; for 5.2 (clinical evaluation) ISO 14155; for 5.3 (chemical, physical and biological properties) ISO 10993, IEC 60601 and IEC 61010; for 5.4 (sterilisation and microbial contamination) ISO 11135, 11137, 11138, 11140, 11607, 10993, 11737, 13408, 14644, 14937, 14698, 17664 and 17665; and for 5.5 (environment and conditions of use) IEC 60601, IEC 61010, IEC 62366-1, IEC/TR 62366-2, IEC 80001 and ISO 80369.

Conditions
  • The table continues on page 27 for the remaining principles (5.6 onward); the excerpt covers pages 26-27 as far as 5.5.
  • The guideline states the standards 'are not intended to encompass all of the requirements' and that product-specific standards may be needed.

Effective from 2023-04-01

The two-column table is rendered here as 'principle: standards' pairs; standard designations are transcribed exactly from the PDF text layer. Principle numbering follows the guideline's section 5 (5.1 General, 5.2 Clinical Evaluation, 5.3 Chemical, physical and biological properties, 5.4 Sterilization and microbial contamination, 5.5 Consideration of environment and conditions of use).

Dossier section 8.3 asks for the product certificate, TSE/BSE attestation, the sterilisation standards applied and a certificate of conformity consistent with the declaration of conformity

standards.dossier-certificate-of-compliance-with-recognised-standards
Fact-level verified

In the registration dossier's 'Certificate of Compliance with Recognized Standards' section the applicant should submit the applicable product certificate, a TSE/BSE risk-free attestation letter, the standards used for sterilisation (such as ISO 11135, ISO 11137, ISO 17665, ISO 13408) with information on the sterilisation method(s), and a certificate of conformity in line with the declaration of conformity. For IVDs the same section additionally asks for the applicable certificate of GMP.

Conditions
  • Section 8.2 requires the declaration of conformity on BoMRA's Template III only; other DoC templates are not accepted.
  • Section 8.4 separately requires QMS information and an authentic ISO 13485 certificate (already recorded under qms-audit-inspection).

Effective from 2024-12-09

IVD guideline s. 8.3 reads: 'The applicant should submit the applicable certificate of GMP, product certificate, TSE/BSE risk free attestation letter, standards for sterilization (such as ISO 11135, ISO 11137, ISO 17665, ISO 13408, etc.) with information on sterilization method (s) and certificate of conformity in line with the DoC declared.'

The dossier must show conformity to the Essential Principles, naming the standards applied

standards.essential-principles-conformity-and-standards-declaration
Fact-level verified

Evidence of conformity to the Essential Principles of Safety and Performance must be provided by completing BoMRA's Essential Principles checklist. Where national, international or other standards are used to demonstrate conformity, the full title of the standard, its identifying number, its date and the organisation that created it must be given.

Conditions
  • BoMRA's own device standards are BoBS or international standards (the exemption guideline's declaration-of-conformity template asks for 'Standards Applied (BoBS Standard Or International standards)').

Effective from 2024-12-09

The Essential Principles guideline itself applies to all medical devices including IVDs, and states that where a principle does not apply, justification for its exclusion must be provided.

'Recognized Standards' are national or international standards deemed to offer a presumption of conformity with specific essential principles

standards.recognised-standards-give-presumption-of-conformity
Fact-level verified

BoMRA's registration guideline defines Recognized Standards as national or international standards deemed to offer the presumption of conformity to specific essential principles of safety and performance. The clinical-evaluation guidance uses the same definition. BoMRA publishes no closed list; the applicant names the standards applied in the Essential Principles checklist.

Conditions
  • The Essential Principles guideline (Appendix B) gives an indicative, non-exhaustive mapping of standards to principles; product-specific standards may additionally be needed.

Effective from 2024-12-09

Same definition at s. 3.1.24 of the IVD registration guideline and s. 3.1.21 of the clinical-evaluation guidance ('Standards deemed to offer the presumption of conformity to specific Essential Principles').

Biocompatibility testing is required for patient-contacting materials, on final finished (post-sterilisation) samples, with ISO 10993 taken as the gold standard and deviations justified

testing.biocompatibility-on-final-product-iso-10993
Fact-level verified

Where a device contacts the patient, biocompatibility of all potentially patient-contacting materials is required. Tests should be run on samples from the final product after all manufacturing and processing, including sterilisation; deviations must be justified and generic raw-material supplier claims are generally insufficient. Reports must give, for each test, the predefined acceptance criteria and results. ISO 10993 standards are taken as the gold standard; if testing was not done to a currently recognised standard, the validated alternative method and a justification (for example for nanotechnology devices) must be provided, and deviations from a standard method specified.

Conditions
  • Section 6.6 is marked '(if applicable)'; it forms part of the Class B, C and D technical documentation.

Effective from 2024-12-09

Sterilisation validation evidence (bioburden, pyrogen, residuals, packaging validation) is separately required at s. 6.4 of the same guideline.

Donated sterile medical devices must be accompanied at the port of entry by a certificate of analysis, and used devices by a certificate of refurbishment

testing.certificate-of-analysis-for-sterile-donated-devices-at-port
Fact-level verified

Donated medical devices must obtain port clearance from BoMRA and be accompanied by a valid import certificate, packing list, proforma invoice, airway bill or bill of lading, a certificate of refurbishment for used devices (issued by the manufacturer or a certified company), and a certificate of analysis for sterile medical devices. Donated X-ray equipment must be calibrated and inspected by a qualified medical physicist or certified by an approved radiation body.

Conditions
  • Section 11 applies to donated devices only; the general import-permit sections (8-10) do not impose a certificate-of-analysis requirement on commercial imports.
  • The certificate of refurbishment must state that the device was tested, labelled and packed, and describe replaced or repaired parts and their source with an acceptance report.

Effective from 2021-12-22

Item (g) continues with the required content of the certificate of refurbishment. Section 11.3(vii): 'for X-ray emitting equipment that it shall be calibrated and inspected by a qualified Medical Physicist or certification from any approved radiation body'.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

An aggrieved applicant may make written representations to BoMRA and follow the statutory appeal process

appeal.written-representations-against-a-registration-decision
Fact-level verified

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 stipulated in the Medicines and Related Substances Act or its regulations. The import/export guideline provides a parallel review-and-appeal route for import or export decisions.

Conditions
  • The appeal body and time limits were not evidenced: the guideline defers to the Act or regulations and no device-specific appeal procedure was located.

Effective from 2024-12-09

The guideline's internal cross-reference to 'the MRS Act of 2023' does not match a published instrument (the Acts in existence are MRSA 2013 and MRSA 2025); recorded as written. The parallel provision in the import/export guideline reads: 'Any applicant who is not satisfied by the decision of the Authority in relation to any application to import or export of medical devices may appeal for review of ...' (s. 14, res-bw-g-import-export-md).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

The registration application must state the UDI number (e.g. GS1) where one applies to the device

udi.registration-application-must-state-the-udi-number
Fact-level verified

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 device - where one is applicable to the device. It is a conditional dossier-disclosure duty: the applicant declares the UDI in the application, and the guideline does not thereby require the device to bear a UDI, require a UDI to be assigned, or require the UDI to be entered in a UDI database.

Conditions
  • The duty is expressly conditional in the source ('if applicable'), so a device without a UDI is not excluded from registration by this provision.
  • It is an application-content requirement listed under '5. DEVICE DETAILS' alongside intended use, contraindications, shelf-life and storage conditions, not a labelling or post-market traceability obligation.
  • The guideline's abbreviation list (s. 3.2.23) and definitions (ss. 3.1.28-3.1.29) supply the UDI concept; this section is the only operative use of it found in the in-force device guidelines.

Effective from 2024-12-09

CONTRADICTION AND ADJUDICATION. The existing D18 row refreshed above ('udi.udi-defined-but-no-listing-or-traceability-obligation-evidenced') states that BOMRA/ER/MED/P04/G01 'imposes no UDI labelling, listing or traceability obligation on applicants'. That statement is partly wrong: the same guideline does impose one applicant-facing UDI duty, at s. 5.13, inside the content list for the 'Device details' section of the application. Adjudication: the earlier session read ss. 3.1.28-3.1.29 and the labelling guideline in full and treated the definitions as the guideline's entire UDI content; s. 5.13 sits about 600 lines later in the application-content part of the same instrument and was missed. Because the new claim ('a UDI disclosure duty exists') contradicts a stated absence in the existing row, it is filed under a new key rather than folded into it, so the earlier finding is not silently overwritten; the absence finding itself is preserved in the refreshed row. Bounded to what the passage says: the duty is conditional ('if applicable') and is a disclosure in the application, not a requirement that the device bear a UDI, that a UDI be assigned, or that the UDI be listed in a database. The source's phrase 'such GS1' is quoted exactly as printed; it evidently means 'such as GS1'. Source language is English.

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

udi.udi-defined-but-no-listing-or-traceability-obligation-evidenced
Fact-level verified

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 single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using AIDC and, if applicable, its HRI) based upon standard, with the UDI-DI of that unique identifier being also linked to a jurisdiction-specific public UDI database, and refers to IMDRF/WG UDI/N7Final:2013 for the fundamental concepts of the system. It defines the UDI as a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard that allows the unambiguous identification of a specific medical device on the market, comprising the UDI-DI (Device Identifier) and the UDI-PI (Production Identifier), and notes that 'Unique' does not imply serialization of individual production units.

Conditions
  • These are definitions only, sitting in the guideline's Definitions section; no UDI labelling, UDI listing or UDI database duty is attached to them, and the labelling guideline BOMRA/ER/MED/P04/G03 Iss 1.0 contains no UDI requirement at all. That absence is a search result, not an express statement by the Authority, and is recorded here and in the note rather than in the value.
  • The ss. 3.1.28-3.1.29 entries sit in the guideline's Definitions section (with 'UDI- Unique Device Identifier' repeated in the abbreviation list at s. 3.2.23); they are not located in the application-content or labelling requirements.
  • A UDI requirement is anticipated rather than imposed: the definitions track the IMDRF UDI framework, but the only applicant-facing UDI provision found in the in-force instruments is the conditional application-content field at BOMRA/ER/MED/P04/G01 s. 5.13, filed as the separate fact 'udi.registration-application-must-state-the-udi-number'.
  • The MRSA 2013 traceability provisions reach medicines through the distribution-chain licensing and record-keeping sections rather than a device UDI rule (carried over from the earlier session).

Effective from 2024-12-09

The earlier session filed this row as source-backed-partial because half of its claim was a documented absence; the value has been narrowed here to the positively provable part, and the absence finding is retained in the value and in conditions. What is verified now that the earlier session could not: the complete, unelided text of both definitions has been read back from the in-force guideline (the earlier excerpt elided the UDI-system definition with '...'), and both are confirmed to be definitions rather than operative requirements - the guideline's application-content section (s. 5) and the labelling guideline were each checked and neither imposes a UDI labelling or UDI database duty. The absence evidence retained: BOMRA/ER/MED/P04/G03 Iss 1.0 was re-read in full and contains zero occurrences of 'UDI'; no UDI database and no published device-register field list was found; and the earlier session's searches of the retention, exemption and adverse-event guidelines also returned no operative UDI duty. The row's second half is qualified rather than abandoned by the new fact recording s. 5.13. Source language is English; passage quoted verbatim below, where '[...]' marks the point at which the PDF's page header ('Document No: BOMRA/ER/MED/P04/G01 ... Effective date: 09/12/2024') interrupts the text on the page break - the two definitions are otherwise continuous.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

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)

vigilance.mdae-reporting-timelines
Fact-level verified

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 the primary manufacturer. For marketing authorisation holders the timelines are: serious public health threat events within 48 hours after first knowledge by the manufacturer; death or serious adverse events within 10 calendar days; and all other adverse events, non-serious, suspected and unexpected, within 30 calendar days. BoMRA may agree to exempt common, well-documented events from reporting or convert them to periodic or summary reporting.

Conditions
  • The timelines run from the manufacturer's first knowledge of the event, not from BoMRA's notification.
  • Reports may be made by email, phone, mobile app or web.

Effective from 2023-03-15

Guideline BOMRA/PCT/PV/P10/G01 Iss 1.0, effective 15-03-2023. BoMRA's Customer Service Standards commit to acknowledging receipt of an ADR report within 24 hours.

Related structured datasets

Classification systems · 2 records
Open BoMRA Classes A, B, C and D — in-vitro diagnostic medical devices →
Id

botswana:ivd

Jurisdiction Id

botswana

Domains
  • ivd
Name

BoMRA Classes A, B, C and D — in-vitro diagnostic medical devices

Description

Botswana classifies IVDs on a parallel four-class individual/public-health-risk axis set out in BoMRA's Guideline for IVD Medical Device Classification (BOMRA/ER/MED/P04/G06, Issue 1.0): Class A low individual risk and low public health risk, Class B moderate individual risk and/or low public health risk, Class C high individual risk and/or moderate public health risk, Class D high individual risk and high public health risk, with the guideline's examples running from a clinical chemistry analyser and specimen receptacle at Class A to HIV blood donor screening and HIV diagnostic kits at Class D. Where more than one rule applies, or a device has multiple intended uses placing it in more than one class, it is classified in the higher class.

Classes
  • Id

    a

    Label

    Class A — Low Individual Risk and Low Public Health Risk

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B — Moderate Individual Risk and/or Low Public Health Risk

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C — High Individual Risk and/or Moderate Public Health Risk

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D — High Individual Risk and High Public Health Risk

    Normalized Risk Level

    highest

Regulator

Botswana Medicines Regulatory Authority

Official Domains
  • bomra.co.bw
Source Status

official-source-verified

Reference Sources
  • Title

    BoMRA, Guideline for Application for Registration of IVD Medical Devices, BOMRA/ER/MED/P04/G09, Issue 1.0 — s.4.15

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25877/signed-guid-guideline-for-application-for-registration-of-ivd-medical-devices-er-med-p04-g09-iss1-0.pdf

    Reviewed On

    2026-09-16

    Supports

    The IVD registration guideline publishes the same pathway-and-class timeline table as the device guideline (screening 3 months for notification and 1-2 months by class; abridged 4/6/8 months; full evaluation 8/10/12 months for a foreign manufacturer; expedited 4/6/8 months; WHO CRP 3 months), with the IVD table's columns running Notification, Class B, Class C and Class D.

Source Title

BoMRA, Guideline for IVD Medical Device Classification, BOMRA/ER/MED/P04/G06, Issue 1.0

Source Url

https://www.bomra.co.bw/download/122/registration-screening-query-response/25636/guid-guideline-for-ivd-medical-device-classification-er-med-p04-g06-iss-1-0.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open BoMRA Classes A, B, C and D — medical devices excluding IVDs →
Id

botswana:medical-device

Jurisdiction Id

botswana

Domains
  • medical-device
Name

BoMRA Classes A, B, C and D — medical devices excluding IVDs

Description

The four-class system in BoMRA's Guideline for Medical Devices Classification (BOMRA/ER/MED/P04/G05, Issue 1.0, effective 01-04-2023), which the guideline describes as assigning every medical device to one of four classes by applying the classification rules: Class A represents the lowest risk and Class D the highest. The rules are set out GHTF-style as 6.1 Non-Invasive Devices, 6.2 Invasive Devices, 6.3 Active Devices and further rules, each with illustrative examples; where two or more rules apply, the device falls into the higher class, and where a system and its components fall into different classes each is classified separately.

Classes
  • Id

    a

    Label

    Class A — Low Risk/Hazard

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B — Low to Moderate Risk

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C — Moderate Risk to high Risk

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D — High Risk

    Normalized Risk Level

    highest

Regulator

Botswana Medicines Regulatory Authority

Official Domains
  • bomra.co.bw
Source Status

official-source-verified

Reference Sources
  • Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.7.2 and s.4.15

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Reviewed On

    2026-09-16

    Supports

    The national overlay that turns the class into a procedure and a clock: Class A follows the notification/listing route, and for Class B, C and D the application goes through screening and then evaluation on the pathway whose published target period is fixed by class (full evaluation for a foreign manufacturer: Class A and B 8 months, Class C 10 months, Class D 12 months). The class also fixes the dossier, since the full and abridged dossiers in Table 3 apply to Class B, C and D.

Source Title

BoMRA, Guideline for Medical Devices Classification, BOMRA/ER/MED/P04/G05, Issue 1.0, effective 01-04-2023

Source Url

https://www.bomra.co.bw/download/122/registration-screening-query-response/25637/guid-guideline-for-medical-device-classification-er-med-p04-g05-iss-1-0.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Botswana registration →
Country

Botswana

Jurisdiction Id

botswana

Country Code

BW

Flag

🇧🇼

Regulator

Botswana Medicines Regulatory Authority

Regulator Abbrev

BoMRA

Region

africa

Tier

3

Risk Classification

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

Classes
  • Id

    screening

    Class Name

    Screening — all registration routes (Notification, Class A and B, Class C, Class D)

    Risk Level

    medium

    Pathway

    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

    Official Timeline
    Min

    1

    Max

    3

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    5

    Notes
    • G01 s.4.15 publishes the screening target per route: 'Within 3 months' for the notification pathway, 'Within 1 month' for Class A and B, and 'Within 2 months' for Class C and 'Within 2 months' for Class D. The row publishes that published ladder as a range rather than picking one class.
    • Two query cycles are allowed. Once a query is raised the processing halts until the response is received, and if no response is received within the timeline specified in s.4.15 the application is deemed withdrawn by the applicant (G01 s.4.8(ii)).
    • Only after the screening step is approved does the applicant submit the evaluation application, and the s.4.15 evaluation clocks run from the accepted evaluation application with the evaluation fee paid.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    abridged-evaluation

    Class Name

    Abridged evaluation — Class B, C and D (proof of a reference regulatory agency required)

    Risk Level

    medium

    Pathway

    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

    Official Timeline
    Min

    4

    Max

    8

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    8

    Max

    14

    Notes
    • G01 s.4.15 publishes the abridged target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months', with 'NA' for the notification route; the row carries the published ladder as a range.
    • The abridged route is the one route where a foreign approval does work: G01 Table 3 marks 'Proof of Reference Regulatory Agency' and 'Proof of Marketing Reference Regulatory Agency' as required for the abridged dossier and not required for the full dossier, which makes those two documents the eligibility evidence for entering the shorter route.
    • A Reference Regulatory Authority is defined in G01 s.3.1.25 as an NRA recognised by BoMRA under its policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies' — a policy this review did not retrieve, so the list of recognised authorities is not asserted here.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    full-evaluation-local-manufacturer

    Class Name

    Full evaluation — Class B, C and D, local manufacturer

    Risk Level

    high

    Pathway

    Full evaluation route for a device manufactured in Botswana, with the complete Summary Technical Documentation dossier under G01 ss.6-8

    Official Timeline
    Min

    6

    Max

    10

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    10

    Max

    16

    Notes
    • G01 s.4.15 publishes the full-evaluation target for local manufacturers as Class A and B 'Within 6 months', Class C 'Within 8 months' and Class D 'Within 10 months'; the row carries that published ladder as a range.
    • The full dossier requires, among other items, the Declaration of Conformity, the Certificate of Compliance with Recognized Standards, medical-device quality-management-system evidence, a post-market surveillance plan, an executive summary, the Summary Technical Documentation and device labelling (G01 Table 3).
    • Registration is site specific (G01 s.4.9) and a quality-system audit of the manufacturing site may be conducted as part of the evaluation (G01 s.4.8(v)).
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    full-evaluation-foreign-manufacturer

    Class Name

    Full evaluation — Class B, C and D, foreign manufacturer

    Risk Level

    high

    Pathway

    Full evaluation route for a device manufactured outside Botswana, filed through a Local Technical Representative and submitted electronically through the BRIMS Self Service Portal

    Official Timeline
    Min

    8

    Max

    12

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    12

    Max

    20

    Notes
    • G01 s.4.15 publishes the full-evaluation target for a foreign manufacturer as Class A and B 'Within 8 months', Class C 'Within 10 months' and Class D 'Within 12 months'; the row carries that ladder as a range. This is the route a foreign device manufacturer uses unless it qualifies for the abridged route.
    • Where the applicant is not resident in Botswana it must appoint a Local Technical Representative (also called an Authorized Representative) that is a company residing or incorporated in Botswana, and the LTR is the applicant of record (G01 s.3.1.3).
    • Applications for renewal must be made six months before the existing registration expires (G01 s.4.14), so a registrant has to re-enter the dossier cycle well before the five-year term ends.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    expedited-evaluation

    Class Name

    Expedited evaluation — Class B, C and D

    Risk Level

    medium

    Pathway

    Expedited evaluation route for Class B, C and D under G01 s.4.15

    Official Timeline
    Min

    4

    Max

    8

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • G01 s.4.15 publishes the expedited target as Class A and B 'Within 4 months', Class C 'Within 6 months' and Class D 'Within 8 months'. The expedited clock is the same as, or close to, the abridged clock, so expediting buys little over a supported abridged filing.
    • G01 does not publish the criteria for granting expedited evaluation, and no expedited fee head exists in the in-force schedule, so the route is described here only as the guideline states it.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    who-crp-registration

    Class Name

    WHO Collaborative Registration Procedure — all classes

    Risk Level

    medium

    Pathway

    Registration through the WHO Collaborative Registration Procedure, with the WHO PQ documentation submitted with the application

    Official Timeline
    Min

    3

    Max

    3

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    8

    Notes
    • G01 s.4.15 publishes a single 'WHO CRP — Within 3 months' row with no class columns, which is why this row carries a route-wide exemption rather than a class link. It is the shortest published route in Botswana.
    • The guideline adds a filing condition rather than only a clock: for WHO PQ medical devices the manufacturer has to submit a filled form 2 and form 3 along with the application (G01 s.4.8(vi)).
    • G01 s.4.15's periods are target assessment times; the clock stops while a query is outstanding (G01 s.4.8(ii)).
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    variation

    Class Name

    Post-registration variation — major, minor and notification

    Risk Level

    medium

    Pathway

    Variation application to a registered device under the Medical Devices Variation Guidelines (BOMRA/ER/MED/P09/G01) referenced by G01 s.4.13, with a new dossier required where the change is fundamental

    Official Timeline
    Min

    1

    Max

    3

    Verification Status

    official-verified

    Official Source
    Title

    BoMRA, Guideline for Application for Registration of Medical Devices excluding In Vitro Diagnostics, BOMRA/ER/MED/P04/G01, Issue 3.0, effective 09/12/2024 — s.4.8 processing, s.4.10 validity, s.4.13 variations, s.4.14 renewals, s.4.15 registration timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

    Effective Date

    2024-09-12

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    5

    Notes
    • G01 s.4.15 publishes 'Major Variations — Within 3 months', 'Minor Variations — Within 3 months' and 'Notification variations — Within 1 Month'; the variation ladder is by variation type, not by device risk class, which is why the row carries a route-wide exemption.
    • The registered holder must inform the Authority of any significant change that could reasonably be expected to affect safety or effectiveness, and certain fundamental changes cannot be handled as a variation at all — a new dossier must be submitted (G01 s.4.13).
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    A Reference Regulatory Authority (an NRA recognised by BoMRA under its recognition-and-reliance policy) with a marketing authorisation already granted

    Accepted

    Yes

    Benefit

    This is the only foreign approval that changes the route: proof of the Reference Regulatory Agency and proof of its marketing authorisation are required dossier items for the abridged pathway (G01 Table 3) and not for the full pathway, and the abridged target is 4-8 months against the full foreign-manufacturer target of 8-12 months. It does not replace BoMRA's own evaluation of the abridged dossier.

  • Authority

    WHO Prequalification (WHO Collaborative Registration Procedure)

    Accepted

    Yes

    Benefit

    A dedicated WHO CRP row with a published 3-month target in G01 s.4.15, shorter than any other route; the manufacturer must submit the filled form 2 and form 3 with the application.

  • Authority

    Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)

    Accepted

    No

    Benefit

    The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.

  • Authority

    China NMPA medical device registration certificate

    Accepted

    No

    Benefit

    No route. The NMPA is not named among the ICH members, observers or mutual-recognition-associated authorities in G01 s.3.1.26, and G01's device guideline names no recognition procedure for it. An NMPA certificate may be filed where the Authority asks for proof of registration in other countries, but it carries no procedural benefit and does not abridge BoMRA's evaluation.

  • Authority

    Marketing approval in another SADC state (ZAMRA, SAHPRA, PPB, TMDA)

    Accepted

    No

    Benefit

    No abridgement. SADC and ZAZIBONA procedures cover medicines, not devices, and there is no regional device approval; a SADC registration is not among the Reference Regulatory Authority requirements BoMRA's device guideline states, so it does not shorten the Botswana route.

Key Requirements
  • 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.
Local Rep Required

Yes

Local Rep Name

Local Technical Representative (LTR), also called Authorized Representative — a company residing in or incorporated in Botswana, which is the applicant of record

Mdsap Accepted

No

Mdsap Benefit

MDSAP is not named in BoMRA's in-force device guideline, essential-principles guideline or IVD guideline; the quality-system evidence required in the Class B, C and D dossier is proof of a QMS such as an ISO 13485 certificate or equivalent.

Registration Validity

5 years unless suspended or revoked by BoMRA or terminated by the registrant, subject to annual retention fees, post-marketing surveillance reports and adverse-effect reports; renewal must be applied for six months before expiry

Last Updated

2026-09-16

Verification Status

official-verified

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by BoMRA. Appoint a Local Technical Representative (LTR), also called Authorized Representative — a company residing in or incorporated in Botswana, which is the applicant of record.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to BoMRA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    BoMRA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. BoMRA may issue questions.

    Duration

    1-3 months

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, BoMRA issues Botswana market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 0 records

No maintained record.

Additional certifications and licences · 1 record
Open Botswana certifications →
Slug

botswana

Market

Botswana

Confidence

low

Schemes
  • Id

    bomra-electrical-safety-emc-evidence

    Name

    BoMRA electrical safety and EMC evidence in the device dossier

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Botswana operates no separate electrical-safety or EMC certificate for medical devices: the requirement is satisfied inside the BoMRA registration. G01 s.6.2 requires evidence of conformity to the Essential Principles of Safety and Performance by completing the checklist in BOMRA/ER/MED/P04/G04, and G04 carries the electrical and electromagnetic principles — essential principle 5.3 covers risks from reasonably foreseeable external influences including magnetic fields, external electrical and electromagnetic effects and electrostatic discharge, 5.7.5 requires design that reduces the risk of creating electromagnetic interference, 5.7.6 requires intrinsic immunity to electromagnetic interference, and 5.7.7 requires reduction of the risk of accidental electric shocks in normal use and single fault condition. G04 maps those principles to IEC 60601 and IEC 61010 as recognized standards, and G01's Table 3 makes a Certificate of Compliance with Recognized Standards a dossier item for the Class B, C and D pathways. The binding is candidate because the requirement is read from BoMRA's own essential-principles and registration guidelines rather than from a dedicated electrical-safety instrument.

    Source Urls
    • https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf
    • https://www.bomra.co.bw/download/122/registration-screening-query-response/25638/guid-guideline-for-essential-principles-applicable-to-medical-devices-er-med-p04-g04-iss-1-0.pdf
    Source Binding

    reviewed

  • Id

    bocra-type-approval

    Name

    BOCRA communications equipment type approval

    Category

    Radio Spectrum

    Status

    Mandatory Pre Market

    Object

    Covered Radio Or Terminal Equipment

    Note

    BOCRA states on its Type Approval page that it 'is mandated by Sec 84 of the CRA Act to Type Approve communications equipment that may be connected, used or operated to provide broadcasting or telecommunications services in Botswana', and that the purpose of type approval is to ensure that all radio communication and telecommunication equipment used in Botswana complies with the international standards applicable in Botswana as an ITU Region 1 member, that no substandard equipment representing health and safety hazards is used, that equipment is compatible with the local telecommunications network, and that operating frequencies conform to the Botswana frequency spectrum allocation plan. A medical device with a radio or telecommunications function must therefore hold a BOCRA type approval before it is used in Botswana, in addition to its BoMRA registration; BOCRA publishes a Type Approval Register on the same site.

    Source Urls
    • https://www.bocra.org.bw/type-approval
    Source Binding

    reviewed

  • Id

    bobs-scsr-compulsory-standards

    Name

    BOBS compulsory standards (Standards (Compulsory Standards) Regulations — Botswana Product Conformity Programme)

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Product Under Compulsory Standard

    Note

    BOBS enforces compulsory standards through its Compulsory Standards Unit under the Standards (Compulsory Standards) Regulation (SCSR), which it publishes as the Botswana Product Conformity Programme; the SCSR was published in the Botswana Gazette on 23 June 2023 and its implementation started on 1 April 2024, s.13 of the Standards Act makes violating a compulsory standard an offence, and s.14 sets a penalty of imprisonment for three years and a fine of P3,000.00. The programme is import-facing, so a regulated product needs conformity evidence to enter Botswana. The binding is candidate because the published SCSR regulated-product list that BOBS serves contains no medical device or medical electrical equipment entry on the text recoverable from that list, so whether the programme reaches a given device could not be evidenced and would need confirmation with BOBS.

    Source Urls
    • https://bobstandards.bw/regulation-of-compulsory-standards/
    Source Binding

    candidate

  • Id

    bobs-trade-metrology

    Name

    BOBS Trade Metrology Unit — verification of weighing and measuring instruments for trade

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Regulated Measuring Instrument

    Note

    The Botswana Bureau of Standards, through its Trade Metrology Unit, enforces the Weights and Measures Act Chapter 43:06 by inspecting and verifying weighing and measuring instruments used for trade, with published objectives that include curtailing the importation of substandard weighing and measuring instruments and minimising the use of instruments that do not conform to approved designs. A medical device with a measuring function that is used in trade — most obviously a scale used to determine a price or a dispensed quantity — falls inside that verification duty, which is carried out on the instrument in Botswana and is separate from the BoMRA registration. The binding is reviewed because the Authority's own page states the enforcement duty and the verification service, although the page does not name medical devices.

    Source Urls
    • https://bobstandards.bw/regulation-of-measuring-weighing-instruments-for-trade/
    Source Binding

    reviewed

  • Id

    rpi-ionising-radiation-licence

    Name

    Radiation Protection Inspectorate licence to possess, sell, use or import ionizing radiation sources

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Product Importer Or Use Site

    Note

    The Radiation Protection Inspectorate states that 'pursuant to the Radiation Protection Act, 2006 and Radiation Protection Regulations 2008, any person who wishes to engage in activities which involve ionizing radiation sources must obtain a licence to do so', and lists the licensable activities as acquiring, owning, possessing, transferring, distributing, selling, using, manufacturing, transporting, importing or exporting any radioactive material, substance or source, administering a radioactive substance for diagnosis, treatment or research, and managing or disposing of radioactive waste. Applications are made on Form 2 (Application for License/Permit to Import/Export/Transport/Possess and Use of Radioactive Sources/Generators/Equipment) and Form 01 (Ionizing Safety User Registration), and the Inspectorate publishes its own service clocks: assessment feedback within 10 days, gazette publication not less than 7 days before the Board meeting, and the applicant informed of the Board's decision within 3 days of the meeting. The licence runs to the facility that imports, possesses or uses the equipment rather than to the device's BoMRA registration.

    Source Urls
    • https://www.gov.bw/radiation-protection-inspectorate/licence-possess-sell-and-use-radiation-sources
    Source Binding

    reviewed

Official Sources
  • Authority

    BoMRA

    Topic

    guideline for application for registration of medical devices — dossier requirements, essential-principles evidence and timelines

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25878/signed-guid-guideline-for-application-for-registration-of-medical-devices-bomra-er-med-p04-g01-iss-3-0.pdf

  • Authority

    BoMRA

    Topic

    guideline for essential principles applicable to medical devices — electrical, electromagnetic and shock protection principles and their recognized standards

    Url

    https://www.bomra.co.bw/download/122/registration-screening-query-response/25638/guid-guideline-for-essential-principles-applicable-to-medical-devices-er-med-p04-g04-iss-1-0.pdf

  • Authority

    BOCRA

    Topic

    type approval of communications equipment (Sec 84 CRA Act)

    Url

    https://www.bocra.org.bw/type-approval

  • Authority

    BOBS

    Topic

    regulation of compulsory standards — Standards (Compulsory Standards) Regulations and the Botswana Product Conformity Programme

    Url

    https://bobstandards.bw/regulation-of-compulsory-standards/

  • Authority

    BOBS

    Topic

    Trade Metrology Unit — regulation of measuring and weighing instruments for trade under the Weights and Measures Act Chapter 43:06

    Url

    https://bobstandards.bw/regulation-of-measuring-weighing-instruments-for-trade/

  • Authority

    Radiation Protection Inspectorate

    Topic

    licence to possess, sell and use radiation sources — eligibility, forms and service steps

    Url

    https://www.gov.bw/radiation-protection-inspectorate/licence-possess-sell-and-use-radiation-sources

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