Niger medical device regulations

Selected physical pages 1–4 and 8–9 of the 13-page joint Health/Finance fee order dated 29 March 2023: complete general Articles 1–9, signatures and the complete MD/IVD marketing-authorisation fee row across two pages. Printed CFA amounts for devices from other countries are 300,000 initial, 300,000 major variation, 30,000 minor variation and 150,000 renewal; the UEMOA/CEDEAO row is 150,000, 150,000, 15,000 and 75,000. Article 7 permits later Board deliberations to change fees; these amounts are not claimed to be current. Article 8 expressly names earlier instruments 254/2013 and 0095/2020, without inventing catalogue targets. Pages 5–7 and 10–13 are excluded from this plan.

Selected original physical pages 1, 9 and 10 of a ten-page instrument, signed 22 September 2025. Article 36 expressly requires clinical trials for in vitro diagnostic medical devices and leaves implementation conditions to ANRP. Article 35 provides the clinical-trials committee implemented by Order 570. These selected pages preserve adjacent provisions for context; medicinal experimental-product definitions and requirements are not automatically generalized to all medical devices. All ten original pages were visually read; this is a partial text expression, not a full transcription or a complete IVD application pathway. ANRP's IVD implementation modalities remain unverified.

Four-page implementing instrument expressly linked by Article 1 to Article 35 of Order 382 of 22 September 2025; the latter's Article 36 expressly covers in vitro diagnostic medical devices. Defines CTEC missions, composition, meetings, reporting, conflicts and confidentiality. Institutional relevance does not establish a separate general device premarket committee or IVD dossier adaptation. Signed 4 December 2025; later currentness and referenced administrative arrangements remain unverified. Duplicate Chapter II and the source heading CHPITRE III are preserved.

Signed eleven-page device order of 22 December 2025, citing Decree 2025-149. Article 21 requires prior declaration by each supply-chain actor and refers to Annex V. Article 22 establishes device homologation, a five-year renewable AMM, class A registration and a separate Board fee resolution; the actual homologation list remains to be determined by ministerial order and must include at least classes B, C and D. The collected 41-page companion attachment contains Annexes I–IV and VI, but Annex V is not present in that expression. This does not prove that no other official expression exists. Articles 5–6 bind essential requirements to Annex III, whose section B expressly excludes IVDs. All 11 main-order pages were read and visually checked. Gazette publication, later amendments, the specific list, Annex V and later fee decisions remain unverified.

Official 41-page companion attachment to Order 633 of 22 December 2025. It contains Annex I terminology, Annex II classification, Annex III essential requirements, Annex IV establishment conditions and Annex VI device AMM/renewal dossiers and product-characteristics form. Annex V cited by the main order is not present in this 41-page expression; no conclusion is drawn about other official expressions. Annex III has general requirements and a section B explicitly for devices other than DMDIV; its B requirements must not be generalized to IVDs. The source heading Annexe VI is retained. All page structures were checked; 29 selected page bodies were read. Later amendments and completeness of the legally referenced annex set remain unverified.

Signed order dated 29 April 2019 expressly modifying and completing the annex to Order 409 of 18 April 2018. Its 10 physical pages retain the two articles, signed endmatter, CNTS blood-transfusion reagents, medical consumables and laboratory equipment with packaging columns, and the appended repeated CNTS and reagent/control/consumable tables. Source numbering omits item 77; repeated lists and printed units are retained. These are emergency-procurement lists and packaging quantities, not a general device homologation-category list or regulatory fees. Order 947 of 5 September 2019 separately modifies and completes Order 409; no whole repeal of Order 505 is inferred. Gazette publication, later changes and current applicability remain unverified.

Order dated 18 April 2018 establishing an emergency medicines, reagents, consumables and device list in a public-procurement context. Article 1 cites Decree 2016-641, Article 7 paragraph 9; Article 3 excludes acquisitions during stock rupture from that procurement Code field and permits periodic revision. This selected expression retains all four articles and signed endmatter, and the medical-device/consumable, dialysis, HGR equipment and laboratory-reagent tables on 13 physical pages, including small mixed medicine tables printed on those pages. Eight medicine-only annex pages are excluded. It is not the ministerial homologation-category list required by Order 633, Article 22. Orders 505/2019 and 947/2019 expressly modify and complete its annex; this original is not consolidated. Later changes, Gazette publication and current applicability remain unverified.

Signed ministerial order dated 4 March 2026 governing creation, operation, renewal, premises modifications and transfer of health-product manufacturing/preparation establishments; Article 2 includes medical devices. Article 14 specifies two months after the inspection request and a five-year operating permission. Article 18 requires permission for premises modifications; Article 19 treats transfer as a new opening. Article 22 gives existing establishments one year from Gazette publication to comply. All nine pages were fully read and visually checked. Duplicate Article 12, the Chapter V-to-VII jump, printed cross-references and the malformed si aucune effectuée sentence are preserved. Gazette publication and later amendments remain unverified. Article 7 expressly cites Decree 2025-149 Article 92; the parent original physical page 30 has been compared and confirms the responsible pharmacist authority, resources and quality-system duty. This resolved parent link does not establish product AMM approval or replace device importer licensing.

Selected original physical pages 1, 71–73 and 143 of the 143-page official ampliation of Decree 2025-149 of 18 March 2025. Articles 353–358 include devices in other-health-product authorization, establishment, good-practice, inspection and AMM provisions; Article 365 provides device declaration, a ministerial homologation list and essential-requirement assessment. Operative comparison with already registered Order 633 and annex confirms device declaration, homologation, dossier and essential-requirement rules, while the actual homologation list and Annex V declaration form remain unverified. Order 377 Article 7 expressly implements the responsible pharmacist authority, resources and QMS duty in parent Article 92, separately read on original physical page 30. This does not turn the five-page published expression into a full 143-page transcription. Transitional actor wording and general repeal remain as printed; Gazette publication and later currentness remain unverified.

Signed ministerial order dated 22 September 2025 establishing the national vigilance system. Articles 3 and 7 expressly include medical devices and IVDs. Articles 30–37 address vigilance systems, local responsible persons, data retention and safety reporting for the stated health-product operators. Notification deadlines and periodic-report format, frequency and content depend on further ANRP rules or decisions. All 13 pages were fully read and visually checked. The printed CTV/CTEV difference and grammatical anomalies are retained. Gazette publication, implementing decisions and later amendments remain unverified.