Burundi medical device regulations

Complete 11-page signed joint ordinance, all 11 articles and nine integral tariff tables. The handwritten number and 10 August 2026 signature date were visually verified on the original; article 11 commences it on signature. Annex tables expressly distinguish local/imported devices and IVDs and risk classes A–D; they also cover annual retention, renewal, minor/major variations, inspections, import/export, promotion, quality control and penalties. Table II states variation fees as percentages of initial homologation fees; no single fixed fee or universal processing time is inferred. Article 9 repeals contrary earlier provisions, rather than naming a complete repeal of every prior tariff. The seven annex pages have a visually reviewed transcription bound to the exact source PDF, preserving currency, row associations, duplicate row numbers and the printed fine “8 000 0000”; original page images accompany the text.

Complete 19-page signed decree with all 43 articles, including the programme-responsibility tables. Lists ABREMA under Ministry supervision and expressly covers device quality, manufacture, import/export, labelling, storage, distribution, vigilance, clinical trials, registration and authorisations. The original header and signature page both read 18 September 2025, and article 43 commences it on signature; the 2026 tariff preamble instead cites this decree with 19 September, an inconsistency retained without silently changing either original. Article 41 repeals contrary earlier provisions; the specific ABREMA organisation continues to be governed by its own establishing text.

Complete 16-page signed replacement expression revising the 2 August 2013 homologation ordinance, with all 39 articles. The defined pharmaceutical-input scope includes articles used for diagnosis, screening, surgery and health protection. Retains registration, reliance, renewal, written variation applications (article 19), retention, suspension and appeals; medicine-specific CTD, labelling and emergency provisions are preserved in context. Articles 9, 11, 19 and 34 refer to separate implementing directives, inspection rules, forms and procedures that must be checked before treating this ordinance as a complete device dossier or change checklist. Article 39 commences it on signature, 9 August 2023; the expired twelve-month transitional submission window is not a current extension.

Complete 12-page signed decree with 39 articles and its integral organisation-chart annex. Expressly assigns ABREMA responsibilities for medical devices, registration, manufacture, import/export, labelling, storage, distribution, surveillance, clinical trials and inspections. Article 39 commences the decree on signature, 26 February 2021. The handwritten official number has been visually checked against the scan; OCR can misread 039 as 034. Original chart geometry is retained.

Complete 64-page signed law, including all 232 articles. Articles 1–3 cover other health products and define medical devices, accessories and operating software; later provisions address authorisation, manufacture, import/export, distribution, inspection, medical optics, advertising and sanctions. Medicine-specific clauses remain distinguishable from device and general health-product provisions. Commences on promulgation, 8 May 2020, under article 232. The original ABREMA-hosted scan is transcribed with French OCR; this is the enacted expression, not an invented consolidated text.

Complete one-page jointly signed public implementation note, dated 10 February 2026. Announces data migration and temporary interruption on 14–16 February, then requires applications and electronic issue of health-product import authorisations through the new platform at gue.obr.gov.bi from 18 February 2026. The migration interruption has elapsed; the replacement submission channel is the continuing procedural instruction. No new product-registration exemption is inferred from this IT change.

Complete five-page stamped original, version 002 dated 19 February 2026. Retains importer, promoter, technical manager and user identification, required supporting documents, existing/new ASYCUDA account cases, additional-user requests, undertakings and the regulator approval section. This form activates access to the health-product import platform; it is not a product marketing-authorisation certificate.

Complete four-page stamped original, version 001 dated 19 February 2026. Includes the organisation and authorised responsible person, existing/new ASYCUDA users, supporting documents, security undertakings and ABREMA approval. Applies to public structures, NGOs and related health-product importers; it does not itself exempt any product from registration or import authorisation.

Complete 76-page signed ministerial order and 2025 national essential-medical-device list, supplied by ABREMA. It revises the 2022 list and includes the equipment/product annex. This instrument establishes the essential-device list; it does not by itself supply a general marketing-authorisation procedure. The searchable text is an OCR transcription of the original scanned publication.

Complete two-page signed ministerial implementation note, visibly dated 2 July 2021. Expressly includes laboratory reagents and consumables, medical materials, devices and equipment, and establishes prior electronic import authorisation and physical inspection before customs liquidation. Its earlier platform instructions must be read with the 10 February 2026 joint note announcing the replacement ABREMA web module from 18 February 2026. The public filename containing 20250407 is not treated as the instrument date.

Complete three-page signed revised instruction, reference 630.7/139/ABREMA/2024 and signature date 23 February 2024 visually checked. Separates general documents, medicine-only requirements and the device/equipment/reagent/consumable requirements for conformity certificates and distribution quality. Covers shipment inspection, French/English labels, equipment donations, cold-chain conditions and import permits valid for twelve months with one three-month renewal. Refers to the separate 2017 National Equipment Harmonisation Guide, still requiring source verification. Read its electronic submission references with the February 2026 replacement web-module implementation note; the ordinary website filename is not the legal date.

Complete original public Word form and instructions, including every requested field, signature line and supporting-document requirement. Requires advance requests and a system-generated inspection sheet, subject to the stated emergency/customs-release exceptions. Retains the publisher’s ASYCUDA wording; read the electronic channel with the February 2026 replacement platform notice. No issue/version date is stated in the form, so a legal date has not been fabricated.

Complete signed ministry guide, October 2018, all 61 physical pages including equipment selection and scoring matrices, national lists by laboratory tier, recommendations, references and the network organigram on the final page. The preface requires prior authority review/approval of new platforms; procurement, donations, supplier maintenance and conformity checks are addressed. The historical ministry and DPML names, named platforms and 2017 survey data are retained as published. WHO catalogue records labelled 2018 and 2021 supplied exactly the same original PDF bytes; 2021 is not a verified revision. This laboratory-specific guide has not been equated with the separate 2017 general equipment harmonisation guide cited in the 2024 import instruction. Later updates, laboratory standards and the current authorisation list remain under review.

Complete 68-page ministry guidance supplied on ABREMA’s current vigilance-text page, with its seven annexes and reporting tools. Its pharmaceutical-product definition includes laboratory/IVD reagents, dressings, devices and consumables, and section II.5 expressly includes medical-device incidents. Much of the clinical material remains medicine-specific. The original DPML-era institutional names and December 2015 edition are retained; read responsibilities with the 2021 ABREMA decree. Diagram and form pages are preserved as original figures, with OCR where the PDF contains image-only form fields. The misleading source filename 'texte_vigilance_publicite' is not a separate advertising regulation or a new 2026 edition.