Sudan medical device regulations

Complete four-page signed Arabic factory-listing regulation, issued under section 40 of the Medicines and Poisons Act 2009. Signed 5 December 2017 and effective on signature. Article 2 repeals the 2010 foreign-factory listing regulation while preserving actions until repealed or varied. Article 4(7) requires written notification of a major change to a listed production line; article 5(5) permits delisting for an unnotified major change. Article 6 permits an additional inspection for a new production line or major line change, five years since the previous inspection, or justified exceptional inspection. The entire original has been visually transcribed and all four page images are retained. It governs factory listing and does not itself supply a complete individual-device variation procedure. Current amendments, fee instruments, listing forms and implementation rules remain under review.

Agency addition/transfer and manufacturer name/address change requirements with product lists, commercial authorization and agent-termination documentation. Medical-supplies factory section 5.2 expressly requests a manufacturing licence, GMP or ISO 13485 and competent-authority confirmation of a name/address change without an actual site move. Medicine, supplement and cosmetics technical requirements are not generalized to devices or IVDs. Controlled-copy code RCh/R/01/02, issue 01, issue date 2022/09/01, blank change number ( ) and expiry 2025/09/01 are retained as printed and are not assumed legal publication/commencement dates. The template has expired; latest-version status and whether it replaces all earlier English guidance remain unverified.

Complete authority-published Arabic and English list, dated 27 March 2023 in the body and posted on 1 April 2023. Both language sections contain the same twenty countries in different orders, and both state that the list will be updated periodically. The original bilingual wording is preserved as one expression. Currentness and scope remain unverified: a separate 11 January 2024 hospital-medicine import clarification publishes a thirty-five-country list, but does not expressly establish that it replaces this list for every device-registration route. Neither webpage is automatically treated as the missing Table 1 incorporated by the 2017 registration regulation, or as the current IMDRF membership list. The complete incorporated original, later updates and route-specific applicability remain under review.

Complete one-page NMPB import and clearance requirements for import companies and national factories under the contract-manufacturing route, printed 29 June 2025. A separate clause requests ISO 13485, CE or an equivalent according to device class, complete labels and analysis for consumables in certain medical-supply transactions. Medicine-only supporting documents remain explicitly conditional. Preserves invoice, clearance, shipment, packing, origin, analysis, prescribed-fee and customs matching steps without inventing a fee amount or processing deadline. The printed date is not treated as a proved legal commencement or evidence that this replaces the later 2026 no-objection procedure.

Complete two-page NMPB controlled guidance, RMd/R/01/03 issue 3, dated 16 August 2020, with printed controlled-copy expiry of 16 August 2023. Clauses a–q cover label location, trade name, identification, manufacturer/importer details, IVD indication, lot/serial/version information, expiry/manufacture date, quantities, storage, sterility, precautions, single use, custom-made devices and separate kit reagents. Both pages and all footer information were visually checked. The same-body stamped scan ce89cf6b… is retained as an alternate expression, not a second instrument. Printed copy expiry is not treated as proof of legal repeal; a renewed controlled copy and applicability in 2026 remain unverified.

Complete single-page NMPB controlled document, issue 3 dated 16 August 2020, with a printed expiry date of 16 August 2023. Retained as a dated source and excluded from default current discovery; the authority’s continuing link and the filename NEW do not establish a renewed version. Lists the STED product-description elements, including intended use, patient population, operating principle, class and classification rule, novel features, accessories and combinations, all configurations/variants, key components including software, patient-contact materials and specifications. The complete native text, control footer and original page image are preserved. The issue and controlled-copy expiry dates do not themselves prove when an underlying legal obligation commenced or ceased. A verified replacement, current applicability and separate variation rules remain under review.

Complete single-page NMPB registration requirements covering manufacturing-site registration, application, fees, acceptable certificates, device description/intended use and labelling for human and veterinary devices. The original footer identifies issue 3 dated 1 August 2019 and an expiry date of 1 August 2022. It remains available on the authority website, but is retained as a dated source and must not be treated as a verified current checklist.

NMPB notice limiting variation procedures to products already registered in its records, explicitly including medical supplies, and excluding unregistered products imported under emergency law.

Complete four-page official compilation: two-page Arabic foreign-factory listing guidance and Arabic/English 20-country SRA annexes, all carrying issue date 27 March 2023 and printed controlled-copy expiry of 27 March 2026. Only section 5 on physical page 2 explicitly includes medical-supplies factories: factories already listed in specified other activities and rejected for medicine manufacture are withdrawn together with previously registered products; factories also producing medicines are not listed in the specified other activities before the medicines-factory decision. This limited mixed-activity condition is not a general MD registration or variation rule. Medicine, biological and antiserum requirements and the SRA annex are retained as source context; their blanket applicability to MD/IVD is not established. Inconsistent printed main-page codes are retained. The annex says it will be updated periodically; the current list, newer controlled guidance and position in 2026 remain unverified.

Complete one-page NMPB controlled requirements, RFm/R/01/01 issue 3, issued 1 August 2019, with printed expiry of 1 August 2022. General section A requires an application and authorized translation for documents outside English/Arabic. Section B.4 expressly addresses medical-device foreign plants: origin manufacturing licence with listed geographic exceptions, origin GMP certificate or ISO 13485, CE certificate as support, and the literal ambiguous line “Document for European countries.” No missing document type is invented for that line. Medicine, supplement and cosmetics sections B.1–3 are retained only as full-page context and are not generalized to MD/IVD. The current controlled copy, interpretation of B.4(4), geographic exceptions and requirements in 2026 remain unverified.

Complete three-page Arabic controlled copy for donations from governments and international organisations, with all original page images and a transcription checked against the visible originals. The footer identifies issue 2 dated 2020/01/02 and amendment 1 dated 2022/08/01; its printed expiry is literally 2023/01/2. Currentness remains unverified because that controlled-copy date has passed, while the authority still publishes a corresponding undated HTML body. This is not proof of either a renewed controlled version or legal repeal. Covers preliminary approval of donated medicines and medical supplies, new and refurbished devices, consumables and all eight clearance-document requirements plus terminal matching and stamping clauses. New devices require operating/maintenance manuals, consumables, accessories and an EC/FDA certificate or registration in an approved regulatory jurisdiction; refurbished devices require preliminary technical-committee approval. Consumables require at least six months’ remaining shelf life on arrival. No legal publication or commencement date is inferred from document-control fields. A verified current version, approved-country applicability and later instruments remain under review.

NMPB electronic import no-objection announcement with separate conditions for registered products and unregistered/emergency devices and supplies. It addresses the method announced on 17 January 2026 and gives device-specific dossier and pro-forma invoice requirements.

Complete one-page NMPB import and clearance requirements, printed 29 June 2025, limited to international organisations with agreements with the Federal Ministry of Health. Expressly covers medical consumables, detailed descriptions for supplies, kits and constituent details, and analysis certificates for medicines and consumables. The separate medicine-registration or Essential Medicines List condition is not imposed on every device. Retains the restricted-medicine condition and the shared approval, shipping, packing, origin and customs or organisation-warehouse matching steps as source context. No fee amount, exemption, approval time or general importer rule is inferred; its relationship to later 2026 procedures remains unverified.

Mixed medicine and nonmedicine variation requirements. Medical-device clauses 2.3/4.3 refer to EC or FDA documentation and 11.2/11.3 to ISO and EC/FDA evidence; agency changes appear in section 12. Dissolution, solid-dosage and excipient provisions are not generalized to all devices or IVDs. Controlled copy issue 3/change 1 prints issue date 01/08/2012 on page 1 and 01/08/2019 on pages 2–5, change date 28/07/2020 and expiry 01/08/2022. These differing source readings are preserved. Current website linkage and a later variation notice do not establish that this expired template is the latest edition; exact incorporation into the 2017 registration rules and later amendments remain open.