🇧🇼 Botswana IVD regulatory data

botswana:ivd

botswana

• ivd

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

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.

• 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

Botswana Medicines Regulatory Authority

• bomra.co.bw

official-source-verified

• 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.

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

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

2026-09-16

• class-axis
• classification-rules

Botswana

botswana

BW

🇧🇼

Botswana Medicines Regulatory Authority

BoMRA

africa

3

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

• 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

• 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.

• 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.

Yes

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

No

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.

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

2026-09-16

official-verified

2026-09-16

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

  ✅

botswana

Botswana

low

• 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

• 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