Botswana medical device regulations

BoMRA's recognition and reliance guideline, Issue 2.0, effective 23 April 2026. It states when BoMRA will accept a foreign authority's inspection or decision instead of repeating the work, which authorities it recognises and on what basis, and how a reliance application is made. Two things about the copy are worth stating, because they are visible in the document itself and a reader should not be surprised by them. First, the document is internally inconsistent about its own title: page 1 of the PDF reads "GMP Recognition and Reliance Guideline", pages 2 to 10 read "Guideline for Good Recognition and Reliance Practices", and its own revision-status sheet records the change ("Changed the document title from 'GMP Inspections and reliance policy' to 'Guideline for Good Recognition and Reliance Practices.'"). Both titles are the source's; neither has been repaired here. Second, the instrument is about inspections of manufacturing sites and mentions devices only in passing — its substance is GMP recognition, not device registration — although its stated legal basis is section 7(a)(i) of the Medicines and Related Substances Act, 2025, an Act whose commencement is ON NOTICE. It is ingested at the title the batch declaration and the PDF's own first page carry.

Issue 3.0, effective 9 December 2024. Sets out when several devices may be covered by a single registration application (system, family, set, IVD cluster, kit) and the criteria each grouping must meet. Do not confuse this with the separate, non-batch BoMRA scan registered under BOMRA/ER/MD/P04/G07, "Reliance/Recognition on Information from Regional and International Bodies" — that is a different document with a near-identical number (ER/MED vs ER/MD); this row is the grouping guidance.

Issue 1.0, effective 9 December 2024. The IVD counterpart to BOMRA/ER/MED/P04/G01 and a separate controlled document with its own number, not a re-publication of it: the two share the BoMRA template and therefore overlap heavily in wording, but each carries its own Document No, issue number, effective date and IVD-specific requirements (analytical performance, self-testing, companion diagnostics). Four annexes with it.

Issue 3.0 of BoMRA's device registration guideline, effective 9 December 2024, and the lead instrument for Botswana device registration. It sets out who may apply (a local applicant acting for the product owner), the class-dependent evidence requirements for classes B, C and D, the dossier contents, screening and query-response timelines, and the marketing history and safety declarations the applicant must sign. Four annexes are ingested with it: the application-form templates, the safety declaration, the declaration of conformity and the marketing history declaration. Read together with the IVD guideline (`botswana-bomra-g-reg-ivd`), which is the same procedure for in vitro diagnostics.

Issue 1.0, effective 1 April 2023. The IVD classification guideline, a separate controlled document from the general classification guideline. It sets the four IVD classes and the seven IVD classification rules (each ingested as its own `rule` block), keyed to individual and public health risk as the IMDRF IVD classification guidance does.

BoMRA's device classification guideline, Issue 1.0, effective 1 April 2023. It establishes the four-class system (A, B, C, D), the manufacturer's duty to classify, and the nineteen classification rules with the illustrative examples BoMRA adopts, keyed to the GHTF/IMDRF rule set. Each rule is ingested as its own `rule` block so a single rule can be cited on its own.

Issue 1.0, effective 1 April 2023. The safety and performance principles a device must satisfy, set out in the IMDRF/GHTF essential-principles structure: general principles applicable to all devices, then the principles specific to devices other than IVDs and the principles specific to IVDs. It is the substantive standard against which a Botswana registration is assessed, and the source of the essential principles Schedule in the draft 2026 Regulations.

Issue 1.0, effective 15 March 2023. Botswana's device vigilance instrument: what a medical device adverse event is, who must report it and to whom, the reporting timelines keyed to severity, the information a report must carry, and the follow-up and signal-review loop. It reaches manufacturers, importers, distributors, health facilities and users, and it is a device-specific document rather than a medicines pharmacovigilance guideline with a device clause attached.

Issue 2, effective 29 November 2022. The recall and withdrawal procedure, and a cross-product instrument: its scope names human and veterinary medicines, cosmetics and medical devices together. It covers the recall classes and the depth of recall, who notifies whom, the recall strategy and its elements, the communication the authority issues, the effectiveness check, and the final report owed to BoMRA within twelve weeks.

Issue 1.0, effective 1 April 2022. How a manufacturer demonstrates clinical evidence for a Botswana registration: the clinical evaluation plan and report, the literature route, equivalence, the clinical-investigation route where the other two do not suffice, and the IVD-specific performance evaluation. The document's own cover calls it a "Guideline for Clinical Evaluation of Medical Devices including IVDs" while the registry title used here reads "Guidance on Clinical Evaluation"; the Document No BOMRA/ER/MED/P04/G02 is the same either way, and the registry title is the one the batch declaration carries.

Issue 1.0, effective 1 April 2022. The labelling requirement for devices and IVDs: the label contents, the language requirement, the symbols and the instructions-for-use contents, with the IVD-specific additions. It is the reference BoMRA applies when it screens the mock-up label submitted with a registration application.

Issue 1.0, effective 22 December 2021. The import and export permit procedure for devices: who may apply, what the application must carry, the permit categories and validity, the conditions attaching to a permit, and the records an importer must keep. It is the instrument that governs a device crossing the Botswana border before or independently of its registration.

The companion draft to the 2026 device regulations: the fee, levy and penalty schedule that would replace the 2019 fee regulations. Forty-seven regulations in ten Parts (regulation 45 the risk-based penalty framework, 46 transitional, 47 repeal), made under the Medicines and Related Substances Act, 2025, with seven Schedules carrying the actual tariffs (product registration, licensing, permits and services, inspections, levies, penalties, and clinical-trial fees keyed to study phase). It is an UNMADE DRAFT: the copy reads "STATUTORY INSTRUMENT NO. ___ OF 2026" and "(Published on _______________, 2026)", both blank, and regulation 1(2) defers commencement to a ministerial Order. Ingested as a draft, not as law.

The draft Botswana device regulation: 127 regulations in 23 Parts, made under sections 80, 81, 82 and 123 of the Medicines and Related Substances Act, 2025. It is the instrument that would introduce device classification (Part on classification, regulations 5 and 6), the essential principles (defined in regulation 2 and set out in Schedule 3; regulation 9 is the application for registration), UDI (Part XII, regulations 95 to 97; regulation 88 is materiovigilance and regulation 92 periodic safety update reports), conformity assessment, registration and licensing. It is an UNMADE DRAFT and is recorded as one: the text reads "(Published on __________, 2026)" with the date left blank, the closing signature block reads "Made this ______________ day of _________________________, 2026. ____ Minister of Health" and is unsigned, and no statutory-instrument number is stated anywhere. Regulation 1(2) defers commencement to a ministerial Order. The draft carries a further internal inconsistency worth knowing: the running footer over the Schedules reads "Medical Devices Regulations, 2025 - Schedules and Prescribed Forms" while the body throughout is the 2026 Regulations. Four Schedules are ingested with it — classification rules for devices, classification rules for IVDs, the essential principles, and the UDI implementation timeline.

Botswana's new medicines statute, assented to on 24 December 2025 and published as Act No. 29 of 2025. It continues the Botswana Medicines Regulatory Authority, restates its functions, and — the reason it is here — carries an express reliance power at section 109 ("Recognition and reliance on regulatory decisions") alongside section 108 (international cooperation) and section 110 (recognition and reliance on laboratory results), plus Part XII (Vigilance and Post-Market Surveillance) and Part XIII (Recall and Disposal of Unfit Products). Scheduling and classification sit in Part XV: section 79 (medicines), section 80 (medical devices) and section 81 (in-vitro diagnostics), and IVDs and medical devices fall in scope through the definition of "medical product". The Act is NOT in force: its own section 1 says it "shall come into operation on such date as the Minister may, by Order published in the Gazette, appoint", and the copy states "Date of commencement: ON NOTICE". It repeals Cap. 63:04 (s.124) and saves subsidiary legislation made under the repealed Act (s.125). The gazette copy's own arrangement page for Parts V and VI sits under a bad OCR text layer ("PART Y - Chief Executive 0//i, (, 011<1 <Jt 11i'I Staff of Authority"); the body pages extract cleanly and are ingested as published, not repaired.

BoMRA's annual retention-fee circular for the 2024/2025 financial year, reference MRA 6/1/2 Vol X (230), dated 18 December 2023 and signed by the Acting Chief Executive Officer. It is the notice that keeps a registration alive: it states the section 24(4) annual-submission duty, requires marketing authorisation holders to price their retained products through the BRIMS self-service portal, sets 31 March 2024 as the payment deadline and April 2024 as the date products fall off the register, and lists the fees "as per Regulations of 2019" — BWP 1,000 for an imported or locally manufactured new chemical entity, BWP 1,000 for a locally manufactured NCE, BWP 500 for a locally manufactured generic, BWP 400 for complementary medicines and BWP 915 for veterinary medicines. Note what the fee lines do NOT contain: there is no medical-device line in this circular. It is a medicines-only notice, ingested because it is the register-maintenance instrument a device holder meets in practice, not because it sets a device fee.