Mauritania medical device regulations

Complete three-article historical decree fixing CAMEC’s margin at seven percent of cost for the named medicines, medical equipment and consumables. Its repeal clause concerns contrary earlier provisions and does not name repeal of the whole 2010 CAMEC decree. The percentage is CAMEC-specific and is not a general device registration fee, a universal IVD rule or a verified current 2026 rate. Later amendments and current applicability remain unverified.

Historical original decree transforming CAMEC into a national company, with all 11 decree articles and selected complete statutes Articles 1–2, 28–29, 42 and 45. It expressly covers medical equipment and consumables in public supply, provides a cost-based margin ceiling, and sets institutional procurement and public-facility price approval arrangements. The statutes also refer to nonprofit private facilities and a ministry supply list that is not supplied here. This is an original historical public-supply source, not a general device registration tariff or a consolidated current law; later implementation and current applicability remain unverified.

Complete two-page signed order supplied by the National Medicines Quality Control Laboratory. Articles 1–4 expressly include medical devices and make a laboratory conformity analysis certificate a prerequisite for registration/marketing-authorisation submissions within the laboratory’s capacity; locally manufactured devices require laboratory release. The website identifies order 663/MS; the damaged date stamp is not converted into an invented legal date.

Complete ministry notice explicitly includes medical devices among products subject to PVCM import conformity checks for shipments from15March2023. It directs importers to alert suppliers/exporters, obtain a conformity certificate and contact the mandated Bureau Veritas programme. The shipment applicability date is not inferred to be a separate statutory commencement. The enabling instrument, precise product/HS list, exemptions, fee procedures and later programme changes remain unresolved.

Organises public agents responsible for legal metrological control under Law 2010-030 and provides a six-month transitional compliance period for holders, users, sellers, manufacturers, installers and repairers of measuring instruments. Article 4 expressly includes medical thermometers and measurements used in health among a broader, non-exhaustive range of instruments and activities. It addresses authorisation of agents, restoration of legal status, withdrawal, sealing, seizure, inspections and infringement reports. This is a general legal-metrology instrument with conditional medical-device relevance; it does not establish a general MD/IVD registration or variation procedure. Printed instrument date is 22 June 2026; the Gazette cover is dated 30 June 2026. No separate effective date or computed transitional deadline is assigned. Later amendments and current applicability remain unverified.

Sets legal units of measurement, model approval, initial and periodic verification, verification after repair or modification, surveillance, control marks and import conditions for measuring instruments under Law 2010-030. Health measurements and the annex’s arterial-pressure and medical-care units establish conditional medical relevance. Article 19 requires notification and complementary or new model approval for qualifying modifications; Articles 47–51 address approved models, declarations before each import, conformity certificates and initial verification. Control fees and category-specific prescriptions remain delegated to Industry ministerial orders; no general device-registration fee or approval SLA is supplied. The complete seven printed unit tables retain source formula, alignment and spelling oddities. Printed instrument date is 24 June 2025; the Gazette cover is dated 15 December 2025. Later amendments and current applicability remain unverified.

Complete five-article historical joint order governing cost-recovery selling prices for essential medicines, medical equipment and consumables. Its formulas distinguish CAMEC, DPR and health-facility selling-price bases, while actual price circulars and revisions are delegated to the ministry and tariff commission. Later CAMEC margin instruments require separate consideration. These are historical supply-price provisions, not device registration fees or verified 2026 selling rates.

Original signed law organising metrology in Mauritania. It expressly includes measurement instruments used in health and public safety and provides the legal-unit, model-approval, first and periodic verification, maintenance, repairer-approval, import, fee-delegation, inspection and penalty framework. The 2025 and 2026 metrology decrees expressly refer to this law. Its measurement scope does not establish that every medical device or IVD is subject to these controls. Current applicability and later amendments remain unverified.

Original signed 2023 decree establishing ONANOR as a public industrial and commercial institution and defining its standards, metrology, conformity-assessment and governance functions. It includes support for measurement-instrument controls and advice on installer and repairer approval. General administration provisions are retained as part of the complete institutional decree; they do not create universal medical-device or IVD product-registration duties. The March Council hearing and May signature dates are distinct. Later changes and current applicability remain unverified.

Original unconsolidated2010 expression of Loi2010-022, selected MD/IVD clauses only: complete identity/promulgation and Article1; Section3 Articles123–124 on reagents; ChapterII Articles125–126 on medical devices; complete inspection Articles128–129 as original administrative context; inspection-obstruction Article146; and Articles151–153 with printed signatories. The2010 inspection wording does not expressly list MD sales establishments and is not expanded to do so. These are historical original provisions:2025-042 amends Articles1,124,126,128,129 and146 and expressly repeals Article152. The entire2010law is not marked repealed. Article152 is retained only as original pharmacy-property transition context, not a device grandfathering rule. Selected regions within physical3,19,20,23,24 of a32-page Gazette are published; neither the whole Gazette nor all22law pages3–24 were read. This is not a consolidated current law or a substitute for2025amendments; later currentness/implementers remain unverified.

Selected medical-device, reagent and medical-consumable provisions of the 2025 amending law, covering quality control, industrially manufactured “produit médical” market authorisation, sales margins, conditional hospital trial handling, import/distribution delegations, inspection and device penalties. Complete relevant clauses are selected on physical pages 4, 6–11 and 14–15 of the 40-page official Gazette, including the complete cross-page text of Articles 61 and 128 and the printed promulgation/signatories. Article 3 expressly repeals only old Article 152; this is not a consolidated version of the 2010 law. The scope of “produit médical”, delegated registration/change procedures, fees and later implementation remain unverified. Remaining pharmacy/professional provisions and unrelated Gazette instruments are excluded.