Cameroon medical device regulations

April 2026 version 1.0 guide to advertising visas and free-unit campaign authorisations, expressly linked to GB4P 2026. It sets out dossiers, evaluation, decisions, refusals, advertising-support changes and withdrawal. It is a common promotion procedure relevant to the device-inclusive GB4P framework; its original medicine-style AMM/RCP and UG conditions are retained without creating universal device registration rules. The maximum two-year advertising visa and thirty-day appeal or campaign-report periods are not product approval timelines. The conflicting substantial/minor-change and all-changes statements remain unresolved.

Selected identity heading and completePartsII/III ofAnnexeI for medical-consumable and IVD packaging/IFU. Medicine-onlyPartI excluded. Heading actually printsNo08/405/PM dated22October1998, while the separately archived decree prints98-405/PM; the mismatch is preserved and formal attachment identity remains unresolved. PartsII/III sayEnglish OR French;2018IVDguide saysEnglish AND French. No unsupported harmonization/currentness closure.

Only complete Articles1–3(scope/definitions),14–16(consumables and IVD homologation),35–37(transitional provisions, fee allocation and general contrary-provision repeal), plus identity/date/signature are published. Article2 continues fromp1top2; its printed numbering3,4,3 is preserved. Article14 explicitly depends on administrative requests/pieces inArticles4/5, which were consulted selectively but not generalized from medicine-specific scientific requirements. PrintedARTICLH15 is preserved. Medicine-specific clinical trialsArticle34 excluded. Current amendments/repeal unresolved.

Undated official DPML medical-device application form for initial homologation, renewal and variation. Blank product identity, description, classification/use, manufacturing/packaging sites, applicant/operator/local representative/pharmacist, lifetime and prices are retained. Three visibly empty outlined drawing boxes are transcribed as □ and remain in page images; no selected state or detailed variation requirements are inferred. Complete two-page derived Word rendering and full source body/header/footer read; later version/current administrative status remains unverified.

Complete undated 83-page authority guide preserved by the Ministry of Public Health’s document library. It includes dedicated requirements for medical devices and IVD reagents alongside medicines and other pharmaceutical products, with classification, dossier requirements, renewals, variations and supporting annexes. It is distinct from the older, shorter submission guide on the DPML website.

Complete institutional advertising visa form expressly listing medical-device wholesale distributors and manufacturers. It covers establishment identity, advertising channels, the responsible pharmacist, seven required supporting documents and DPML decision fields. Promotion is limited to the identity, existence and services of the establishment; specific-product advertising requires a separate visa. The category heading mentions cumulative charges, but the four-page form prints no fee amounts or currency. Its references to other sections are retained as printed.

Ministerial circular dated 17 July 2019 assigning duties to pharmacists in public and private health facilities. It covers procurement and handling of devices and reagents, sterilisation, haemodialysis-water control, qualification and validation of haemodialysis installations, and internal materiovigilance and reactovigilance. The complete five-section circular is retained with its medicine-related context. Later changes remain unverified.

Selected common provisions from the 2026 promotion guide: the cover, glossary and complete operative body. The definitions and scope expressly include medical devices and laboratory or biomedical reagents, subject to the stated marketing authorisation or specific prior ministerial agreement. The source covers promotional-material validation, personnel, vigilance responsibilities, samples, digital promotion, professional interactions and compliance. Medicine-specific wording is retained as context and does not create universal device fees or review deadlines. Separate visa guides and forms remain incompletely reviewed.

Complete operative COVID19-context circular specifically limits medical-device/IVD imports to authorized structures and prior technical import visa. SignedPDF chosen over officialHTML alternative; one instrument only. Source body, identity and date were read visually; nativeOCR misses the operative concluding paragraphs, restored from clearly visible source image. This is not evidence that2020restrictions are unchanged today. Later2023visaDecision0313is separately identified, not merged or treated as an automatic repeal. Partly clipped non-operative footer and seals/signatures remain in source image rather than reconstructed.

Undated official DPML reagent/IVD homologation form with initial, renewal and variation choices. Preserves composition, uses/instructions, WHO prequalification or manufacturing standard, detection threshold/sensitivity/specificity, technique/presentation, supply-chain/local pharmacist fields, lifetime and prices. It is a source form, not proof that WHO prequalification is universally mandatory or a complete variation procedure. All three derived Word pages retained, including the third page containing Visa and footer; current version remains unverified.

Full twelve-page March2018 IVD reagent dossier guide including initial/renewal/variation, analytical-performance composition changes, labelling/IFU and application-template fields. Printed citation says2October1998 whereas the decree original says22October1998; not silently corrected. Page6 numbering omits3. Guide requiresEnglish AND French labels/IFU, whereas archivedAnnexeI PartsII/III saysEnglish OR French; hierarchy, subsequent revisions and present fees remain unresolved. Fee and sample quantities are historical source statements, not a verified current instruction.

Ministerial circular dated 9 April 2026 on recalls and withdrawal of nonconforming health-product lots. It expressly addresses medical-device distributors and describes quarantine, return and reporting through health facilities, wholesalers, manufacturers and DPML. The complete source includes the recall attestation and lot-recall form, with their original drug-style fields and blank cells. Later changes and current applicability remain unverified.

Decision signed on 17 March 2026 making the Guide de Bonnes Pratiques de la Promotion des Produits Pharmaceutiques public. Its four articles state the purpose, name promotion agencies and licensed pharmaceutical manufacturers, and assign implementation and publication duties. The guide separately names medical devices and reagents in its scope. No distinct commencement date or conclusion about later amendments is inferred.

Complete signed two-page Decision0313/D/MINSANTE of22February2023 including Articles1–8. DirectMD evidence is the explicit valid medical-device wholesale-authorization alternative inArticle3(2). The instrument otherwise uses pharmaceutical-product terms; broader medicine-style fields are preserved as source text without asserting new universalMD/IVD duties. Article7 concerns internationally controlled medicines, not a general medical-device obligation. The official procedure index, HTMLarticle and signedPDF are three representations/discovery sources for one instrument; onlyPDF registered. Relationship to2020D36-65importcontrolcircular and subsequent amendments/currentness remains unresolved. Webpage24March2023 and directory24February2023 are not substituted for the printed signed date.