Senegal medical device registration resources

ARP — not the DPM — is the competent authority for medical devices

Device regulation in Senegal is exercised by the Agence sénégalaise de Réglementation pharmaceutique (ARP). Décret n° 2023 2419 never names the Direction de la Pharmacie et du Médicament: i…

Loi n° 2023-06 of 13 June 2023 and Décret n° 2023-2419 of 27 December 2023 form the device legal basis

Senegal's device framework rests on two instruments. Loi n° 2023 06 du 13 juin 2023 relative aux médicaments, aux autres produits de santé et à la pharmacie defines 'produit de santé' to in…

National definitions of medical device, IVD, accessory, intended purpose and life cycle

Décret n° 2023 2419 is the national instrument that defines the regulated object. Article 1 fixes its scope: manufacture, registration, import, export and distribution of medical devices. A…

Senegalese classes A, B, C and D (décret n° 2023-2419)

Classe A — Faible, Classe B — Faible-moyen, Classe C — Moyen-élevé, Classe D — Élevé

Classes B, C and D need a marketing authorisation; class A is a declaration

The device registration dossier is subject to administrative and technical evaluation, and the registration process results in a marketing authorisation for devices of class B, C and D. Cla…

Class C and D devices need a certificate of putting-into-service before any use

A certificat de mise en service is delivered by the pharmaceutical regulation structure before any use of high risk medical devices, notably those of classes C and D. This is a third author…

UEMOA harmonised device dossier makes foreign conformity evidence a mandatory attachment, not a route

statement: The UEMOA device guidelines that Senegal is bound to implement require the marketing authorisation dossier to contain a certified copy of the conformity attestation obtained thro…

Statutory power to recognise foreign vigilance decisions and reports — post-market only, no market access

statement: Senegal's national vigilance system law gives the pharmaceutical regulatory structure an express power to recognise, under predefined conditions, vigilance decisions of other cou…

A local representative is mandatory to file; a vigilance officer resident in Senegal is mandatory to hold

The applicant for a device marketing authorisation files with the ARP through its local representative. The UEMOA harmonised framework, which Senegal transposes, requires a manufacturer wis…

Each device establishment activity needs its own ARP agreement, gated by prior inspection

Establishments or companies whose object concerns medical devices are agreed by decision of the ARP's Director General to carry out wholesale and/or retail distribution of medical devices,…

The national device dossier contents are not in the decree or the arrêté — they are delegated to unpublished ARP Director-General decisions

The composition of the application dossier for a device marketing authorisation, for a variation, for a renewal, for an import authorisation and for a distribution agreement, and the modali…

No source-verified answer is published for this dimension yet.

Technical documentation must be established in the national official language (French)

The manufacturer must establish, in the national official language, the technical documentation required for the conformity assessment, the identification and the use of the medical device,…

Good-practices compliance duty and official inspection of the device supply chain

Compliance with the good practices in force is made an express statutory duty of medical device manufacturers and distributors: 'Art. 41. Les fabricants et les distributeurs sont tenus au r…

ARP essential requirements — electromagnetic compatibility

EMC

ARP essential requirements — protection against electrical hazards

Electrical safety

ARTP prior agrément for radioelectrical equipment

Wireless / radio

Marketing authorisation — Class D device, registration (enregistrement)

XOF 1,000,000

Marketing authorisation — Class D device, renewal (renouvellement)

XOF 500,000

Establishment agrément — manufacture, import, registration, export, distribution and maintenance of medical devices · Agrément d'établissement decided by the ARP Director-General (décret n° 2023-2419, art. 28; arrêté, arts. 2-14), after a prior inspection for manufacturing and wholesale-import establishments

3 months

ARSN authorisation — device or installation using ionizing radiation · Autorisation issued by the ARSN under loi n° 2021-44 du 31 décembre 2021, with separate application forms for importation, exportation, détention et utilisation, and transport

15-30 days

Five-year marketing authorisation; device renewal due 120 days before expiry, establishment agreement six months

The device marketing authorisation for classes B, C and D is valid for five years, renewable. A renewal application for a device marketing authorisation must be filed 120 days before its ex…

Any change to a device marketing-authorisation dossier requires a variation request

Any modification of the application dossier for a device marketing authorisation requires a variation request in accordance with the regulations in force; the composition of the variation d…

Statutory 'listing' of devices plus manufacturer and distributor traceability duties

Senegal's device decree creates a national data collection mechanism called 'listing' and a manufacture to final use traceability duty, but it does not create a UDI issuer or a public UDI d…

Clinical evaluation for all devices and clinical investigations on human subjects

Décret n° 2023 2419 makes clinical evidence an element of the essential requirements for every medical device. Annexe 1 (the essential requirements, made an integral part of the decree by a…

Devices supplied for sale or as donations must comply with the decree's essential requirements (Décret 2023-2419, Art. 30)

Medical devices offered for sale or given as donations must comply with the essential requirements of the decree; donation is therefore not a derogation from the safety, quality and perform…

The Law's donation-import and exceptional individual-import derogations (Art. 140-141) are drafted for medicines only; import conditions for other health products are left to a ministerial order (Art. 142)

Loi 2023 06 provides that import/export conditions for donated medicines are fixed by joint order of the Finance and Health Ministers (Art. 140) and that, by derogation from Art. 138, impor…

Manufacturer's continuing post-market reporting, risk-reduction and documentation duties

Décret n° 2023 2419 places continuing post market obligations directly on the medical device manufacturer. The seventh indent of art. 34 requires the manufacturer to 'informer immédiatement…

National vigilance system with ARP-hosted organs; matériovigilance is a named component of device post-market surveillance

Matériovigilance is defined in the device decree as the surveillance of incidents linked to the use of medical devices, and the device post market surveillance system comprises import/expor…

ARP Director General may suspend or withdraw a device marketing authorisation for public-health danger

Any device marketing authorisation may be suspended. Suspension is imposed for a determined period where there is a suspicion of danger to public health or where the device actually present…

Promotion and advertising control as a component of device market surveillance, under the national advertising authorisation regime

Two instruments together govern promotion and advertising of medical devices in Senegal. First, Décret n° 2023 2419 art. 43 makes 'le contrôle de la promotion et de la publicité' an express…

Standing ARP complaints channel, and no dedicated appeal against device regulatory decisions

Senegal provides a general written channel for contesting or commenting on ARP action, but the device decree creates no dedicated appeal against its own decisions. The ARP operates a public…