Agence sénégalaise de Réglementation pharmaceutique (ARP) · structured requirements

🇸🇳 Senegal medical device regulatory data

Explore the medical device requirements currently available for Senegal, organized by topic and linked to official sources.

32 facts24 dimensions9 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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

advertising.device-promotion-and-advertising-control

Fact-level verified

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 component of the medical-device post-marketing surveillance system, so device advertising is a regulated post-market activity controlled by the pharmaceutical-regulation structure. Second, the substantive authorisation regime is Décret n° 2023-2424 du 27 décembre 2023 fixant les conditions d'autorisation de la promotion ou de publicité sur les médicaments et autres produits de santé, taken under art. 55 of Loi n° 2023-06: art. 1 fixes its object as the conditions for authorising promotion or advertising of 'médicaments et autres produits de santé'; art. 3 subjects promotion through an advertising medium or by the giving away of free units to an authorisation issued by the pharmaceutical-regulation structure; art. 33 reserves advertising to products for which a marketing authorisation has been obtained and requires any advertisement to respect the marketing authorisation, to conform to the summary of product characteristics, to favour rational use and not to harm public health; art. 34 lists prohibited elements (presenting the medical act as superfluous, suggesting the effect is acquired, suggesting absence of side effects, claiming superiority or equivalence over another product, claiming that a normal state of health can be improved, assimilating the product to a foodstuff, referring to certificates of cure, insisting that a marketing authorisation has been obtained); art. 35 forbids anticipating pending variations; art. 36 requires comparative advertising to be based on comparable and relevant characteristics and not to be denigrating or misleading; art. 37 prohibits advertising to the general public; art. 38 reserves advertising strictly to public-health professionals and requires the information to be exact, up to date, verifiable and sufficiently complete; art. 39 makes professional advertising controlled by the regulation structure and lists the permitted channels; art. 40 creates an evaluation and validation commission for advertising requests; art. 42 provides that the composition of the advertising-authorisation dossier is fixed by decision of the Director-General; art. 43 permits campaigns for priority health programmes to address the general public only where preventive or public-health protective. Sanctions for advertising or promoting without authorisation are listed in art. 44: urgent stopping of the advertising campaign, urgent stopping of the promotion of the product, suspension of the marketing authorisation, withdrawal of the marketing authorisation, and a fine of 1,000,000 to 2,000,000 CFA francs, with the same fine for advertising on an unauthorised medium. The ARP also lists the UEMOA 'LIGNES DIRECTRICES POUR LE CONTRÔLE DE L'INFORMATION ET LA PUBLICITE SUR LES MEDICAMENTS AUPRES DES PROFESSIONNELS DE LA SANTE DANS LES ETATS MEMBRES DE L'UEMOA' in its official guideline library, matching the Décision n° 10/2010/CM/UEMOA cited in the visas of Décret n° 2023-2424.

Conditions

Décret n° 2023-2424 never uses the word 'dispositif': its operative articles are drafted in terms of 'médicament' and 'autres produits de santé'. Senegal's device decree is taken under the law 'relative aux médicaments, aux autres produits de la santé et à la pharmacie' (its rapport de présentation records that Loi n° 2023-06 art. 244 referred device implementation to a decree, and art. 45 sanctions non-compliance with the device decree under that same law), so devices fall within the 'autres produits de santé' limb of the statute whose scope words the advertising decree repeats.
Décret n° 2023-2424 regulates promotion and advertising; it does not create a separate device-claims substantiation rule or a claims register.
The ARP's public reminder 'rappel de la réglementation sur la publicité des médicaments et autres produits de santé' is listed on https://arp.sn/publications/ but its published file is not a readable text instrument, so it is not relied on.

Effective from 2023-12-27

Source is French. The passages are quoted verbatim below with an English translation. The device-specific hook is Décret n° 2023-2419 art. 43; the substantive authorisation regime is Décret n° 2023-2424. The supporting source r204-sn-decret-2023-2419 was re-read in full for this fact (arts. 27-48 and Annex 1).

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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

validity.five-years-and-renewal-deadlines

Fact-level verified

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 expiry date at the ARP. Separately, an establishment agreement is granted for five years, renewable, and its holder must submit a complete renewal application six months before the agreement expires. The two clocks differ and run on different instruments.

Conditions

The 120-day pre-expiry filing window for a device authorisation comes from the ARP arrêté; the six-month window for an establishment agreement comes from Décret n° 2023-2419.
The renewal dossier composition is delegated to an unpublished ARP Director-General decision (arrêté art. 21).
Late renewal of a registration attracts a penalty of 1% of the renewal amount per day of delay under the fee decree.

French original. Translation: 'Art. 32. - The agreement is granted by decision of the structure in charge of Regulation for a renewable period of five (05) years. The agreement may be suspended or withdrawn in the event of breach of the provisions of this decree.' and 'The holder of the agreement must submit a complete renewal application dossier six (06) months before the expiry of the said agreement.' Read directly from the Journal officiel n° 7704 text layer (p. 225 and p. 848 of the gazette's continuous pagination). The 120-day device-authorisation renewal window is arrêté n° 011772 art. 21: 'Toute demande de renouvellement d'autorisation de mise sur le marché d'un dispositif médical est déposée cent vingt (120) jours avant son délai d'expiration au niveau de l'Agence sénégalaise de Réglementation pharmaceutique.'

Authority & regime

Which authority and binding regime govern this product, task, and date?

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

authority.arp-competence-over-devices

Fact-level verified

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: it makes registration, import, export, distribution and sale of medical devices subject to an agrément delivered by 'la structure en charge de la réglementation' (art. 27), and art. 31 makes the pharmaceutical-regulation structure the coordinator of device regulation, while art. 42 places market surveillance with the Ministry of Health. The ARP's arrêté confirms the position operationally: the marketing authorisation for class B, C and D devices is issued by decision of the ARP's Directeur Général (art. 17), import of any device requires an ARP authorisation (art. 25), and establishment agréments for device manufacture, distribution and export are granted by the ARP's Directeur Général (arts. 2-3, 8-10, 27). The arrêté's visas record that the ARP was created by Décret n° 2022-824 du 7 avril 2022, as modified by Décret n° 2023-2418 du 27 décembre 2023.

Conditions

Senegal holds WHO maturity level 3 for medicines; the ARP site states ML3 for medical devices as a future goal, so the ARP is not a WHO-listed authority for devices.

French original. Translation: 'Art. 27. - The registration, import, export, distribution and sale of medical devices are subject to obtaining an agreement delivered by the structure in charge of regulation.' and 'Art. 42. - The medical device market is subject to surveillance by the Ministry in charge of Health.' Read directly from the Journal officiel n° 7704 text layer. The ARP arrêté's arts. 17 and 25 name the Agence sénégalaise de Réglementation pharmaceutique expressly (read by OCR of the ARP's scanned arrêté).

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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

change.variation-request-required

Fact-level verified

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 dossier is fixed by a decision of the ARP Director General. The fee decree prices variations at two levels — major variation and minor variation — with distinct amounts per class. The classification criteria distinguishing a major from a minor variation are not stated in either instrument.

Conditions

Existence, cost and route of the variation are verified; the criteria distinguishing major from minor, and the decision clock, are not.
The variation dossier composition is among the delegations to an unpublished Director-General decision.

French original. Translation: 'Article 20.- Any modification of the application dossier for a marketing authorisation for a medical device requires a variation request in accordance with the regulations in force. The composition of the application dossier for a variation of a marketing authorisation for a medical device is fixed by decision of the Director General of the Agence sénégalaise de Réglementation pharmaceutique.' Read by OCR of the ARP's scanned arrêté.

Classification rules

What local class follows from which rules and decisive product facts?

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Four risk classes A/B/C/D, with rule-based classification and IVD escalation to class D

classification.four-classes-a-b-c-d

Fact-level verified

Medical devices are classified in four categories according to the level of risk they present: class A (low), class B (low/medium), class C (medium/high) and class D (high). The decree sets out the classification rules article by article in the same structure as the WHO/IMDRF scheme adopted regionally — for example, all non-invasive devices that come into contact with lesioned skin are class A if intended only as a mechanical barrier, for compression or for absorbing exudates; class B if intended mainly for wounds involving destruction of the dermis, including devices intended mainly to treat the microenvironment of a lesioned mucosa; class C if intended mainly for wounds involving destruction of the dermis that can only heal by second intention. In-vitro diagnostic devices are class C except for the determination of the ABO, rhesus, Kell, Kidd and Duffy systems, which are class D.

Conditions

The classification rules and the class bands are regionally mandated by the UEMOA guidelines (Annexes I-1 and I-2); Senegal's decree is a transposition.
A class A/B declaration versus authorisation discrepancy between the fee decree and the ARP arrêté affects the practical consequence of the class boundary — see registration.amm-classes-b-c-d-and-declaration-class-a.

French original. Translation: 'Art. 3. - Medical devices are classified into four (04) categories according to the level of risk they present. The different classes of medical devices as well as the classification rules are defined as follows: CLASS / LEVEL OF RISK — A Low; B Low/medium; C Medium/high; D High.' Read directly from the Journal officiel n° 7704 text layer (p. 224); art. 4 and art. 20 are quoted in the conditions above from the same text layer.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evaluation for all devices and clinical investigations on human subjects

clinical.clinical-evaluation-and-investigation-requirements

Fact-level verified

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 art. 44) provides at B14.1 that for all medical devices 'la démonstration de la conformité aux principes essentiels comprend une évaluation clinique conforme aux directives de l'autorité compétente' (demonstration of conformity with the essential principles includes a clinical evaluation in accordance with the directives of the competent authority), and that the clinical evaluation should examine clinical data in the form of clinical investigation reports and of literature reviews and clinical experience, in order to establish that the device presents a favourable benefit/risk ratio. B14.2 governs investigations on human subjects: they 'devrait être réalisée conformément à l'esprit de la Déclaration d'Helsinki', covering every stage from consideration of the need for and justification of the study through to publication of the results, with the further caveat that some countries may have specific regulatory requirements for protocol review before the study or for informed consent. The labelling requirements of the same annex require devices intended for clinical investigations to carry the mark 'exclusivement pour investigations cliniques' (B13.1, item h). The clinical-trial decree of the same date, Décret n° 2023-2422, is not the instrument for device investigations: its Article 2 defines 'essai clinique' as 'étude systématique des produits pharmaceutiques sur des sujets humains' (a systematic study of pharmaceutical products on human subjects). Performance data and validation requirements sit in sections B1 to B13 of the same annex, and the technical documentation that must underpin the evaluation is required by art. 34 to be drawn up 'dans la langue officielle nationale'.

Conditions

Décret n° 2023-2419 does not itself prescribe an authorisation procedure, a fee, a clock or a format for a device clinical investigation on human subjects; it imposes the ethical standard (Declaration of Helsinki) and the benefit/risk demonstration through the annex, while Décret n° 2023-2422 governs clinical trials of pharmaceutical products only.
The ARP publishes 'LIGNE DIRECTRICE RELATIVE A LA CONDUITE D'ESSAIS CLINIQUES AU SENEGAL' and its emergency-situation companion on https://arp.sn/lignes-directrices/; both are image-only scans on the ARP site, so their device scope could not be read.

Effective from 2023-12-27

Source is French. The annex passages are quoted verbatim below with an English translation. Art. 44 of the decree provides 'L'annexe I est partie intégrante du présent décret.'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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

scope.device-ivd-accessory-and-lifecycle-definitions

Fact-level verified

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. Article 2 defines 'dispositif médical' by the manufacturer's intended purpose, with four limbs (diagnosis/prevention/monitoring/treatment/alleviation of disease; diagnosis/monitoring/treatment/alleviation/compensation of an injury or handicap; study, replacement or modification of anatomy or of a physiological process; control of conception), expressly including the software necessary for the device to function and expressly requiring that the principal intended action is not obtained by pharmacological, immunological or metabolic means while allowing the function to be assisted by such means. Two further categories are 'également réputés être des dispositifs médicaux' (also deemed medical devices): devices for the control of conception or assistance thereto, and products specifically intended for cleaning, disinfecting or sterilising devices. The same article defines 'accessoire d'un dispositif médical', 'dispositif médical de diagnostic in vitro', 'dispositif médical actif', 'dispositif médical implantable', 'dispositif médical invasif', 'dispositif médical à usage unique', 'dispositif médical destiné à des autodiagnostics', 'dispositif sur mesure', 'cycle de vie' (from initial design to decommissioning and disposal) and 'destination'. It also defines the negative categories 'dispositif médical de qualité inférieure', 'dispositif médical falsifié', 'dispositif médical non enregistré/non homologué' and 'marché illicite de dispositifs médicaux'.

Conditions

The definitional content of Décret n° 2023-2419 art. 2 is transposed from the UEMOA lignes directrices that the decree's visas adopt (Décision n° 3/2022/CM/UEMOA du 24 juin 2022), so the two texts use the same terms; the national decree is the operative instrument in Senegal.
Loi n° 2023-06 du 13 juin 2023 relative aux médicaments, aux autres produits de santé et à la pharmacie remains the parent statute; the decree's rapport de présentation records that 'La loi n° 2023-06 du 13 juin 2023 en son article 244 a renvoyé à un décret pour fixer les modalités de son application.' Loi n° 2023-06 is published by the ARP only as an OCR text layer over a scan, so it is not relied on for any excerpt here.

Effective from 2023-12-27

Source is French. The passage is quoted verbatim below with an English translation. The decree is the national implementing instrument; the UEMOA lignes directrices are the regional harmonisation basis cited in its visas, not a separate operative regime.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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

dossier.composition-delegated-to-director-general-decisions

Fact-level verified

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 modalities of the class A declaration, are each fixed by a decision of the Director General of the ARP rather than by the decree or the arrêté. Those decisions are not published on the ARP's decisions page, so the exact national dossier contents — and whether any origin-country document is required at national level — cannot be confirmed from a published official source. The regional UEMOA harmonised dossier is the only published statement of what the device dossier contains.

Conditions

Ten separate delegations to a Director-General decision appear in the arrêté alone (arts. 5, 7, 12, 14, 16, 19, 20, 21, 26 and 28 in the relevant parts).
For an applicant this means the national dossier checklist is obtainable only directly from the ARP, not from the published texts.
The UEMOA harmonised dossier content is stated in reliance.uemoa-harmonised-dossier-foreign-attachments and is the best available proxy.

French original of the central delegation: 'Article 19.- La composition du dossier de demande d'autorisation de mise sur le marché des dispositifs médicaux est fixée par décision du Directeur général de l'Agence sénégalaise de Réglementation pharmaceutique.' Read by OCR of the ARP's scanned arrêté. The ARP's decisions page (https://arp.sn/les-decisions/) was enumerated in this round and carries no medical-device dossier decision.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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

roles.local-representative-and-resident-vigilance-person

Fact-level verified

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 wishing to place devices on the market in its own name without a registered office in the UEMOA area to designate a local representative established in the UEMOA area, and provides that the manufacturer remains the sole principal and remains responsible for its product even when it contracts with a representative or subcontractor. Separately, any producer or holder of a marketing authorisation for a medicine or other health product in Senegal, or its representative, must permanently retain the services of a qualified person resident in Senegal responsible for vigilance matters and with proven vigilance experience, and must establish and maintain a vigilance system.

Conditions

The local representative is not merely a filing agent: it serves as the official interface between the manufacturer and the regulatory structure for regulatory questions and applies the traceability system.
The UEMOA text makes the local representative a requirement of the UEMOA SPACE, not of Senegal alone — the representative may be established anywhere in the UEMOA area.
The vigilance-responsible person is subject to a Senegal residence requirement, which the local-representative rule is not.

French original. Translation: 'Article 18.- The applicant for a marketing authorisation, through its local representative, files with the Agence sénégalaise de Réglementation pharmaceutique an application dossier for the evaluation of class B, C and D medical devices.' Read by OCR of the ARP's scanned arrêté. The UEMOA local-representative rule is at §4.2.1 of the harmonised guidelines; the resident vigilance person is Décret n° 2023-2423 art. 15, read from the Journal officiel n° 7704 text layer: 'dispose en permanence des services d'une personne qualifiée, résidant au Sénégal, responsable des vigilances et justifiant d'une expérience en matière de vigilances'.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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

establishment.agrement-per-activity-and-inspection

Fact-level verified

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, after examination by a commission created for that purpose; the agreement specifies the class of devices and the authorised distribution activities for each type of establishment. Grant of an agreement for specialised wholesale and/or retail distribution establishments is subject to a prior inspection. Pharmaceutical wholesale import/export establishments, depositaries and distributing wholesalers are agreed by ARP decision to carry out wholesale distribution of medical devices, and pharmacies and in-house pharmacies are authorised to sell at retail only the medical devices on a list fixed by decision of the ARP's Director General. Export of devices is reserved to manufacturing establishments and wholesale distribution establishments agreed by ARP decision, and concerns only devices holding a Senegalese marketing authorisation.

Conditions

The establishment agreement is valid five years, renewable; the holder must submit a complete renewal dossier six months before expiry.
The dossier composition for the distribution agreement is delegated to an unpublished decision of the ARP Director General (arrêté arts. 12 and 14).
Export is conditional on the device already holding a Senegalese marketing authorisation, and must not compromise national availability or accessibility.

French original. Translation of art. 10: 'Establishments or companies whose object concerns medical devices are agreed by decision of the Director General of the Agence sénégalaise de Réglementation pharmaceutique to carry out the wholesale and/or retail distribution of medical devices, after examination by the commission created for that purpose. The grant of an agreement for specialised wholesale and/or retail distribution establishments is subject to a prior inspection in accordance with the regulations in force.' Read by OCR of the ARP's scanned arrêté. The five-year term and six-month renewal window are Décret n° 2023-2419 art. 32 and the following paragraph, read from the Journal officiel text layer.

Fees

What regulator fee applies to this class, route, event, and date?

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Device registration fees: class D 1 000 000, class C 500 000 FCFA; class A and B declaration 10 000 FCFA

fees.device-registration-by-class

Fact-level verified

The pharmaceutical-regulation fee decree fixes device homologation fees in CFA francs. For a class D device: registration 1 000 000; renewal 500 000; major variation 1 000 000; minor variation 250 000. For a class C device: registration 500 000; renewal 250 000; major variation 500 000; minor variation 250 000. For class A and B devices, a declaration of medical devices: 10 000, with no deadline. Where the applicant is a local industry, the marketing authorisation is 500 000 for registration, 500 000 for renewal, 250 000 for a major variation and 125 000 for a minor variation. Late renewal carries a penalty of 1% of the renewal amount per day of delay.

Conditions

The class A/B declaration line conflicts with the ARP arrêté, which puts only class A on declaration and requires an authorisation for class B — the schedule appears not to have been updated to match the later arrêté.
No fee line for the import authorisation or for the certificat de mise en service was located in the decree.
The late-renewal penalty of 1% per day is stated on the class C and D registration rows.

French original table. Read from the Journal officiel n° 7871 (numéro spécial) text layer, pp. 1660-1661. Amounts: 'Dispositif Médical de classe D — Enregistrement 1 000 000 ; Renouvellement 500 000 ; Retard de renouvellement 1% du montant du renouvellement par jour de retard ; Variation majeure 1 000 000 ; Variation mineure 250 000' and 'Dispositif Médical de classe A et B — Déclaration de dispositifs médicaux — 10 000 — aucun délai'. There is no class B registration line in the schedule at all, only the combined A-and-B declaration line. Fee dimensions are on the 12-month re-verification cadence.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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

label.technical-documentation-in-official-language

Fact-level verified

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, and must establish a declaration of conformity and affix the conformity marking once the product has been shown to meet the applicable essential requirements. The UEMOA harmonised dossier adds that the summary of the device's characteristics and technical specifications must be in the country's official language and that the labelling model and the instructions-for-use model are filed with the dossier, and that the labelling, outer packaging or instructions for use of devices imported into the Community must additionally carry the name and address of the responsible person, the manufacturer's representative or the importer established in the Community.

Conditions

The Senegalese rule is expressed as an obligation on the manufacturer to establish the technical documentation in the official language, i.e. French.
The UEMOA rule on identifying the Community-established responsible person is a labelling content requirement, not merely a language rule.
No Senegalese provision fixing the language of the marketed label after grant, separate from the technical documentation, was located.

French original. Translation: 'establish in the national official language the technical documentation required for the conformity assessment, the identification and the use of the medical device'. Read directly from the Journal officiel n° 7704 text layer (p. 225). The UEMOA corroboration is at Annexe IV-1 'Documents techniques' point 5 and Annexe II-1 §B13.1 point 1.a) of the harmonised guidelines.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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

legal-basis.loi-2023-06-and-decret-2023-2419

Fact-level verified

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 include medical devices and in-vitro diagnostic devices and, in its art. 43, provides that the conditions of manufacture, registration, import and wholesale and retail distribution of medical devices are fixed by decree — it contains no self-executing device rules. Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux is that decree: it carries the essential requirements in its Annexe I, the risk classification in art. 3, the authorisation and import routes and the post-market surveillance system. An ARP arrêté of 2026 then fixes the establishment-agreement modalities under art. 28 of the decree.

Conditions

Loi n° 2023-06 also places implantable medical devices and in-vitro diagnostic devices intended for public use inside the pharmacist monopoly for import, export, wholesale, retail and dispensing.
Décret n° 2023-2419 was published in the Journal officiel n° 7704 of 24 February 2024.
The ARP arrêté is registered under reference 011772 with a registration stamp of 22 mai 2026; the arrêté's own 'Arrêté n°' field is blank and the number is taken from the registration stamp.

French original. Translation: 'Art. 26. - The essential requirements relating to the quality, safety and performance of medical devices (MD) are defined in Annex I of this decree.' Read directly from the Journal officiel n° 7704 text layer. Loi n° 2023-06 is published by the Ministry of Health and Social Action at https://www.sante.gouv.sn/sites/default/files/loi-n%C2%B02023-06-du-13-juin-2023-relative-aux-medica_230616_125053.pdf and is cited in the arrêté's visas; its art. 43 delegation is quoted in the conditions above from that published text.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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

pms.manufacturer-post-market-obligations

Fact-level verified

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 et mettre à la disposition de la structure en charge de la Réglementation pharmaceutique, tout rapport d'événement indésirable d'un dispositif médical qu'il reçoit ou qu'il possède après investigation, ainsi que les mesures correctives de sécurité mises en œuvre' (immediately inform, and make available to, the pharmaceutical-regulation structure any adverse-event report concerning a medical device that it receives or holds after investigation, together with the safety corrective measures implemented). The eighth indent requires it to 'contribuer, à la demande de la structure en charge de la Réglementation pharmaceutique, à la mise en œuvre de toute mesure adoptée en vue de réduire autant que possible les risques présentés par le dispositif médical mis sur le marché' (contribute, at the request of the regulation structure, to the implementation of any measure adopted to reduce as far as possible the risks presented by the device placed on the market). The same two duties are imposed on distributors and manufacturer representatives by the second and fifth indents of art. 35, and the ninth indent of art. 34 keeps the manufacturer the sole principal ('demeurer le seul donneur d'ordre, responsable de son produit même en cas de contractualisation avec un représentant ou un sous-traitant'). The fourth indent of art. 34 requires the technical documentation and declaration of conformity to be kept for the product's life cycle. Art. 43 makes after-sales service ('le service après-vente'), quality control, promotion and advertising control, the fight against substandard and falsified devices, inspection of supply-chain actors and matériovigilance components of the device post-marketing surveillance system.

Conditions

The decree imposes immediate adverse-event reporting, the safety-corrective-measure report and ad-hoc risk-reduction cooperation; it does not impose a periodic safety update report, a named post-market surveillance plan or a manufacturer risk-management plan. The nearest equivalent is the risk-management plan that the UEMOA technical-documentation annex requires for the device's life cycle, which Senegal adopted through the decision cited in the decree's visas.
Enforcement follows art. 45 (non-compliance sanctioned under the law on medicines and other health products) rather than a device-specific penalty schedule; the ARP's own post-marketing-surveillance guideline is an image-only scan and could not be read.

Effective from 2023-12-27

Source is French. The articles are quoted verbatim below with an English translation. The distinction between the obligations actually imposed by the decree and the periodic-reporting and risk-management-plan duties it does not impose is drawn from a full reading of arts. 34, 35, 40-43 and Annex 1 of the decree.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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

qms.good-practices-compliance-and-supply-chain-inspection

Fact-level verified

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 respect des bonnes pratiques en vigueur.' For manufacturers this is particularised by the fifth indent of art. 34, which requires a newly established device manufacturing establishment to 'se conformer et appliquer les normes de bonnes pratiques de fabrication des dispositifs médicaux en vigueur' (comply with and apply the good manufacturing practice standards for medical devices in force). Official control is two-layered: 'Art. 42. - Le marché des dispositifs médicaux est assujetti à une surveillance par le Ministère en charge de la Santé.' (the medical-device market is subject to surveillance by the Ministry of Health), and the post-marketing surveillance system of art. 43 expressly includes 'le contrôle de qualité' (quality control) and 'l'inspection des différents acteurs de la chaîne d'approvisionnement' (inspection of the various actors in the supply chain) alongside import/export control, after-sales service, promotion and advertising control, the fight against substandard and falsified devices and illicit sale, and matériovigilance. A separate conformity-certificate concept exists in the definitions: a 'certificat de conformité' is a written attestation issued by a conformity-assessment body recognised by the competent authority stating that the device manufacturer correctly applies the essential requirements.

Conditions

Décret n° 2023-2419 creates the compliance duty and the inspection power; it does not itself establish a registration-time QMS audit programme, an ISO 13485 certification requirement or GMP-certificate submission rule for devices.
Enforcement of the good-practices duty runs through art. 45, which routes non-compliance to the sanctions of the law on medicines and other health products rather than to a device-specific penalty schedule.

Effective from 2023-12-27

Source is French. The articles are quoted verbatim below with an English translation. The ARP's own inspection guideline ('LISTE DE CONTRÔLE POUR L'INSPECTION DES ESSAIS CLINIQUES', 'GUIDE D'INSPECTION DES ESSAIS CLINIQUES') and its market-surveillance guideline are listed on https://arp.sn/lignes-directrices/ but are published only as image-only scans with zero extractable text and could not be read.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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

recall.suspension-and-withdrawal-by-arp-director-general

Fact-level verified

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 presents a danger to public health. The suspension decision is taken by the ARP's Director General and notified to the marketing-authorisation holder, who may supply any necessary information. Lifting of the suspension may be requested from the competent authority where, within six months of notification of the suspension, withdrawal of the authorisation has not been pronounced. Any marketing authorisation may be withdrawn where the device actually presents a danger to public health; the withdrawal act is pronounced by the ARP's Director General and notified to the holder.

Conditions

The measure operates on the marketing authorisation (suspension/withdrawal), not on individual batches; no batch-recall or field-safety-corrective-action procedure for devices was located.
The decree does not set a decision clock for the suspension, nor a procedure for challenging it.
The ARP's general post-market surveillance includes inspection of supply-chain actors and the fight against illicit sale, which are the enforcement complements.

French original. Translation of art. 22: 'Any marketing authorisation for a medical device may be subject to suspension. The suspension of the medical device is carried out, for a determined period, when: there exists a suspicion of danger for public health; it actually presents a danger for public health. The decision to suspend the medical device is taken by the Director General of the Agence sénégalaise de Réglementation pharmaceutique and is notified to the holder of the marketing authorisation, who has the option of providing any necessary information.' Read by OCR of the ARP's scanned arrêté.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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

registration.amm-classes-b-c-d-and-declaration-class-a

Fact-level verified

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. Class A devices are instead the subject of a declaration to the ARP on the basis of a conformity evaluation, with the declaration modalities fixed by decision of the ARP's Director General. The marketing authorisation for classes B, C and D is issued by decision of the ARP's Director General and is valid for five years, renewable. The list of devices subject to the homologation procedure is fixed by the ARP and must contain at least devices of classes B, C and D.

Conditions

The applicant files the class B, C and D dossier through its LOCAL REPRESENTATIVE — a foreign manufacturer cannot file directly.
The dossier composition for the authorisation, the variation, the renewal, the import and the establishment agreement is in each case delegated to a decision of the ARP Director General, which is not published (see dossier.composition-delegated-to-director-general-decisions).
The fee schedule bands class A and B together as a declaration at 10 000 CFA francs, which conflicts with the arrêté's treatment of class B as an authorisation; the arrêté is the later and more specific instrument.

French original. Translation: 'Article 15.- The medical-device registration dossier is subject to an administrative and technical evaluation. The registration process for a medical device results in the grant of a marketing authorisation for medical devices of class B, C and D.' / 'Article 16.- Class A medical devices are the subject of a declaration to the Agence sénégalaise de Réglementation pharmaceutique, on the basis of an evaluation of their conformity.' / 'Article 17.- The marketing authorisation for class B, C and D medical devices is delivered by decision of the Director General of the Agence sénégalaise de Réglementation pharmaceutique. This marketing authorisation is valid for a period of five (05) years, renewable.' Read by OCR of the ARP's scanned arrêté at 200 dpi with Tesseract (fra).

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

registration.certificat-de-mise-en-service-high-risk

Fact-level verified

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 authorisation, distinct from the marketing authorisation and from the import authorisation, and it gates clinical use rather than supply.

Conditions

The obligation is stated for high-risk devices and expressly names classes C and D.
No procedure, dossier or fee for the certificat de mise en service was located in this round; the fee decree carries no line for it.

French original. Translation: 'Art. 40. - A certificate of putting into service is delivered by the structure in charge of Pharmaceutical Regulation before any use of high-risk medical devices, notably those of classes C and D of medical devices.' Read directly from the Journal officiel n° 7704 text layer.

Import of ANY medical device, whatever its class, needs a prior ARP authorisation

registration.prior-import-authorisation-any-class

Fact-level verified

The import of any medical device, whatever its class of belonging, is subject to a prior authorisation from the pharmaceutical regulation structure; the ARP arrêté states that the import of any medical device is subject to an authorisation delivered by the ARP. Under the decree, registration, import, export, distribution and sale of devices are subject to an agreement from the regulation structure, while the manufacture of devices is subject to an authorisation delivered by order of the Minister in charge of Health. A device therefore needs both its marketing authorisation or declaration AND a separate import authorisation for each shipment or import operation.

Conditions

The import authorisation is a distinct act from the marketing authorisation, and it applies at every class including class A, which needs no marketing authorisation.
The dossier composition for the import-authorisation application is delegated to an unpublished decision of the ARP Director General (arrêté art. 26).
For high-risk devices there is a third act: see registration.certificat-de-mise-en-service.

French original. Translation: 'Art. 36. - The import of any medical device, whatever its class of belonging, is subject to a prior authorisation from the structure in charge of Pharmaceutical Regulation.' Read directly from the Journal officiel n° 7704 text layer. The ARP arrêté art. 25 restates it: 'L'importation de tout dispositif médical est subordonnée à une autorisation délivrée par l'Agence sénégalaise de Réglementation pharmaceutique.' (OCR).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Senegal approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Senegal (4 records)

SenegalWHO

Prior approval / evidence record

WHO prequalification

Authority: WHO prequalification
Accepted: No
Benefit: No reliance route is published: the ARP assesses the dossier itself, and the UEMOA harmonisation leaves the marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).

Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux, Journal officiel n° 7704 du 24 février 2024, arts. 34, 36, 38, 39 and 40 Arrêté du Ministre de la Santé et de l'Hygiène publique pris en application de l'article 28 du décret n° 2023-2419, fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux — arts. 15-21, 25 and 29 (registered 22 May 2026)ARTP procédure d'agrément d'équipement radioélectrique — requirements under art. 70 of loi n° 2018-028 du 12 décembre 2018 portant Code des Communications électroniques ARSN, « Combien de temps prend le traitement d'une demande ? » — published treatment time, validity and renewal of a radioprotection authorisation

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

SenegalEU conformity assessment

Prior approval / evidence record

EU CE marking / notified-body certificate

Authority: EU CE marking / notified-body certificate
Accepted: No
Benefit: Not a substitute for ARP registration, but the technical file, the déclaration de conformité and the test reports behind a CE certificate are the same evidence the ARP requires for the enregistrement dossier.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

SenegalSource authority not specified

Prior approval / evidence record

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

reliance.uemoa-harmonised-dossier-foreign-attachments

Fact-level verified

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 through the international procedures recognised by the competent authority, a copy of any good-manufacturing-practice certificate for medical devices in force, a document attesting first placing on the market, a batch conformity certificate, and an indicative-price document. These are mandatory attachments inside a full national evaluation: the harmonised dossier has no abridged branch keyed to a foreign approval, and the foreign documents do not displace the essential-requirements checklist, the technical documentation or the national decision.
Source Approval: Conformity attestation obtained under the international procedures recognised by the competent authority (the guidelines do not name any scheme), plus a GMP certificate, a first-marketing document and a batch conformity certificate
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

This is the UEMOA harmonised dossier, which Senegal must implement; the Senegalese arrêté instead delegates the national dossier composition to unpublished decisions of the ARP Director General, so this fact describes the regional requirement rather than a verbatim Senegalese one.
The guidelines never name CE, FDA or any other scheme — the same 'reconnues par l'autorité compétente' formula as Côte d'Ivoire's AIRP procedure.
The UEMOA text is the regional instrument; Senegal is a member state and its Décret n° 2023-2419 cites the decision in its visas.

French original. Translation: '2. a certified copy of the conformity attestation obtained through the international procedures recognised by the competent authority; 3. a copy of any good-manufacturing-practice certificate relating to medical devices in force; 4. a document attesting the first placing on the market; 5. a conformity certificate for the lot of the medical device; 6. an indicative-price document for the medical device.' The 63-page annexes were retrieved from a text-layer PDF hosted by the Agence béninoise du médicament, an official national agency site; the ARP's own copy of the parent decision returns HTTP 404 (link rot).

SenegalSource authority not specified

Prior approval / evidence record

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

reliance.vigilance-decisions-recognition

Fact-level verified

Statement: Senegal's national vigilance system law gives the pharmaceutical regulatory structure an express power to recognise, under predefined conditions, vigilance decisions of other countries or regional or international bodies, and to adopt their vigilance reports and information. This is a genuine reliance mechanism in Senegalese law, but it is confined to the post-market vigilance domain: it grants no premarket market access, no shortened review and no product authorisation. It is the sharpest statement of where foreign-regulator reliance legally exists in Senegal for health products.
Source Approval: Vigilance decisions, reports and information of other countries or of regional or international bodies — the source names no specific authority or scheme
Edge Type: Abridged Or Recognition Route
Market Access Strength: none
Regulatory Layer: Postmarket Surveillance
Local Application Required: No
Target Decision Retained: No

Conditions

The mechanism is a power of the regulatory structure, not an applicant-facing route: a marketing-authorisation applicant cannot use it to obtain access.
The decree does not name which foreign decisions are recognisable, so the power is discretionary and its practical scope is unpublished.
marketAccessStrength is 'none' because the recognition operates on safety decisions and reports, not on product authorisation.

French original. Translation: 'The structure in charge of Pharmaceutical Regulation may, under predefined conditions, recognise vigilance decisions or adopt vigilance reports and information from other countries or regional or international bodies.' Read directly from the Journal officiel n° 7704 text layer, p. 251.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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ARP decides on an agreement application within three months; incomplete dossiers notified within two working days

clock.three-month-decision-and-two-day-completeness-notice

Fact-level verified

Where the dossier is declared incomplete, the ARP notifies the applicant of the missing items within two working days; the instruction period is then suspended until the required items are received. This two-working-day completeness notice is the only statutory service standard on the completeness check, and it runs in the applicant's favour by starting the suspension only after notification.

Conditions

The three-month clock runs from receipt of a COMPLETE dossier, and is suspended by the two-day completeness procedure.
The arrêté states the clock for 'toute demande d'agrément'; the decree sets no separate clock for the device marketing authorisation itself, so this is the only published device-side decision clock.

French original. Translation: 'Article 29.- The Agence sénégalaise de Réglementation pharmaceutique rules on any agreement application within a period of three (03) months from receipt of a complete dossier. Where the dossier is declared incomplete, it notifies the applicant, within a period of two (02) working days, of the missing items. The instruction period is then suspended until receipt of the required items.' Read by OCR of the ARP's scanned arrêté. Review clocks are on the 12-month re-verification cadence.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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

special.donated-devices-must-meet-essential-requirements

Fact-level verified

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 performance requirements.

Conditions

The decree contains no separate donation authorisation procedure for devices; importation of any device of any class remains subject to prior ARP authorisation under Art. 36.

Effective from 2024-02-24

English gist as in value.

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)

special.donation-and-individual-import-derogations-limited-to-medicines

Fact-level verified

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, import/export authorisations may exceptionally be granted to private individuals under conditions set by decree (Art. 141); both are limited to 'médicaments'. For non-medicine health products, including devices, import/export conditions are fixed by order of the Minister of Health (Art. 142), and the Law contains no device-specific donation or individual-import derogation.

Conditions

Verified negative for the Law only: Titre on importation/exportation (Art. 136-142) read in full; the Art. 142 arrêté for non-medicine health products was not located.
Décret 2023-2419 Art. 36 requires prior ARP authorisation for importing any device of any class.

Effective from 2023-06-13

English gist as in value.

For public-health reasons, exceptional derogations in the form of special authorisations (temporary use authorisations) may be granted for categories of medicines and other health products; modalities by ministerial order (Loi 2023-06, Art. 134)

special.special-authorisations-atu-for-health-products

Fact-level verified

Article 134 of the Law allows, for public-health reasons and on an exceptional basis, derogations in the form of special authorisations for certain categories of medicines and other health products, notably temporary use authorisations (ATU) and temporary use recommendations; the conditions for granting them are fixed by order of the Minister of Health.

Conditions

The article covers 'médicaments et autres produits de santé', hence medical devices; the implementing arrêté was not located on arp.sn or sante.gouv.sn on 2026-09-16, so no device ATU procedure is documented.
Art. 133 (prior AMM before any supply) is drafted for 'médicament' only; device marketing authorisation is governed by Décret 2023-2419 Art. 38-39.

Effective from 2023-06-13

English gist as in value. The bracketed omission is an OCR-garbled fragment of the second paragraph that reads, in the scan, as temporary use recommendations for medicines ('RTU').

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Décret 2023-2419 defines the certificate of conformity (issued by a recognised conformity assessment body), the manufacturer's declaration of conformity and the conformity assessment body (Art. 2)

standards.conformity-certificate-declaration-and-assessment-body-definitions

Fact-level verified

A 'certificat de conformité' is a written attestation issued by a conformity assessment body recognised by the competent authority stating that the manufacturer correctly applies the essential requirements; a 'déclaration de conformité' is the manufacturer's own written attestation that it applied the conformity-assessment elements for the device's class; an 'organisme d'évaluation de la conformité (OEC)' is a body other than a regulator charged with determining whether the relevant regulatory requirements or technical standards are met.

Conditions

Definitions only; the decree does not designate or list recognised conformity assessment bodies.

Effective from 2024-02-24

English gist as in value. Art. 34 requires the manufacturer to draw up a declaration of conformity and affix the conformity marking once the essential requirements are shown to be met.

Placing on the market of devices subject to homologation requires a conformity evaluation against the essential requirements, reviewed administratively by ARP, technically by an expert committee and validated by a national commission (Art. 39)

standards.conformity-evaluation-three-stage-homologation-review

Fact-level verified

Devices on the homologation list may be placed on the market only after a conformity evaluation against the essential safety, quality and performance requirements, sanctioned by a marketing authorisation; the homologation dossier undergoes an administrative evaluation by ARP, a technical evaluation by an expert committee and validation by a national commission, whose creation, composition and functioning are fixed by ministerial order.

Conditions

Applies to devices on the ARP homologation list, which must contain at least classes B, C and D (Art. 38).
The arrêté creating the expert committee and national commission was not located on arp.sn on 2026-09-16.

Effective from 2024-02-24

English gist as in value. Art. 40 adds that high-risk (class C and D) devices need a 'certificat de mise en service' before use, granted on a document certifying conformity after technical evaluation (already recorded under registration-pathways).

Essential requirements for quality, safety and performance are fixed in Annexe 1 of Décret 2023-2419 (Art. 26)

standards.essential-requirements-annex-i

Fact-level verified

Article 26 provides that the essential requirements on quality, safety and performance of medical devices are defined in Annexe 1 of the decree, titled 'Les exigences essentielles relatives à la sécurité et à la performance des dispositifs médicaux', which opens with general requirements (A) on risk acceptability, state-of-the-art design and intended performance, followed by design and manufacturing requirements (B) up to B14 clinical evaluation. No harmonised or recognised standards list is published; conformity is assessed against these essential requirements.

Conditions

The decree names no ISO/IEC standards; Art. 34 separately requires manufacturers to apply the good manufacturing practice standards in force.

Effective from 2024-02-24

English gist: Art. 26 sends essential requirements to Annex 1; Annex 1 general requirements mirror the GHTF/IMDRF essential principles (risk acceptability, risk-control hierarchy, intended performance).

ARP may base market-surveillance decisions on analytical results and regulatory decisions of maturity-level-3 authorities and recognises test results of accredited or WHO-prequalified laboratories (Décret 2023-2420, Art. 14)

testing.recognition-of-ml3-regulator-and-who-prequalified-laboratory-results

Fact-level verified

In market surveillance of medicines and other health products, ARP may found its decisions on the analytical results and regulatory decisions of other national regulatory authorities of at least WHO maturity level 3 or equivalent, or of control authorities with which it has a recognition agreement; test results from laboratories accredited and/or prequalified by WHO are also recognised.

Conditions

Décret 2023-2420 covers 'médicaments et autres produits de santé'; the Law's definition of 'produit de santé' includes medical devices including IVDs, so devices are within scope.
Non-conforming products are quarantined, batch-withdrawn, suspended or definitively withdrawn after post-market testing (Art. 13).

Effective from 2024-02-24

Article premier: 'Le présent décret fixe les conditions de mise en œuvre de la surveillance du marché des médicaments et autres produits de santé.' Loi 2023-06 definition: 'produit de santé : médicaments, dispositifs médicaux y compris ceux de diagnostic in vitro, les produits cosmétiques et d'hygiène corporelle, les compléments alimentaires ainsi que tout produit classé dans cette catégorie par arrêté du Ministre en charge de la Santé'.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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

submission.complaints-channel-and-absence-of-dedicated-appeal

Fact-level verified

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 'RÉCLAMATIONS / SUGGESTIONS' form that any person can use: it records Date, the addressee chosen from a dropdown of every ARP directorate, service and unit — including 'Direction de l'Homologation et de la Sérialisation des Médicaments et autres Produits de Santé' with its 'Service des essais cliniques' and 'Service de l'homologation des médicaments, vaccins et autres produits de santé', 'Direction du Contrôle de la Qualité', 'Direction de l'Inspection Pharmaceutique, de la Surveillance du Marché et des Vigilances' and 'Direction des Affaires Juridiques / Service des études, de la législation et du contentieux' — the 'Nature de la déclaration' (Suggestion, Réclamation / Plaintes, Autres), contact fields (Nom / Prénom, Téléphone, E-mail, Fonction / Entreprise) and a free-text Message. The ARP also publishes a dedicated instrument, 'LIGNE DIRECTRICE POUR LES PLAINTES, RÉCLAMATIONS CONTRE LES DÉCISIONS RÉGLEMENTAIRES', in its official guideline library. Against that, Décret n° 2023-2419 contains no appeal article: art. 37 provides only that the regulation structure 'peut retirer, suspendre ou annuler une autorisation d'importation de dispositifs médicaux sur décision motivée'; art. 32 provides that the agrément 'peut faire l'objet de suspension ou de retrait en cas de manquement aux dispositions du présent décret' without stating a recourse; and art. 45 refers non-compliance to the sanctions of the law on medicines and other health products. The only express recourse in the 2023 health-products decrees is in Décret n° 2023-2424 art. 45: 'Les sanctions peuvent faire l'objet de recours suivant les conditions normales de droit commun.'

Conditions

The ARP guideline on complaints and challenges against regulatory decisions is the instrument that would supply the procedural detail (deadlines, competent body, effect on the contested decision); it is published on https://arp.sn/wp-content/uploads/2023/04/Ligne-directrices-sur-les-plaintes-et-reclammations5016.pdf as an image-only scan with no extractable text, so the procedural detail could not be stated from the instrument itself and is only located, not sourced.
The decree's own dossier-processing communications are the deficiency-notice practice implied by art. 39 (administrative evaluation, technical evaluation, national commission validation) rather than a codified clock or a codified right of reply.

Effective from 2023-12-27

Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux — Journal officiel de la République du Sénégal n° 7704 du samedi 24 février 2024, pp. 219-231 Lignes directrices et guides de bonnes pratiques — bibliothèque officielle de l'Agence sénégalaise de Réglementation pharmaceutique Décret n° 2023-2424 du 27 décembre 2023 fixant les conditions d'autorisation de la promotion ou de publicité sur les médicaments et autres produits de santé — Journal officiel de la République du Sénégal n° 7704 du samedi 24 février 2024, pp. 253-257

Source is French. The form labels are quoted verbatim below with an English translation, together with the decree articles that establish the negative (no dedicated appeal in the device decree).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

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

traceability.device-listing-and-manufacturer-identification-system

Fact-level verified

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 database. Art. 2 defines: 'listing : processus de recueil d'information relative aux dispositifs médicaux (DM) en vue de constituer une base de données dynamique pour tous les acteurs de la chaîne d'approvisionnement sous la responsabilité de la structure en charge de la réglementation pharmaceutique' — i.e. the collection of information on medical devices to build a dynamic database for all supply-chain actors, under the responsibility of the pharmaceutical-regulation structure. On the manufacturer's side, the sixth indent of art. 34 requires it to 'élaborer et mettre en œuvre un système d'identification qui permet une traçabilité adéquate depuis la fabrication jusqu'à l'utilisation finale du dispositif médical' (devise and implement an identification system allowing adequate traceability from manufacture to final use of the device), alongside the fourth indent's duty to keep the technical documentation and the declaration of conformity for the product's life cycle. On the distribution side, the fourth indent of art. 35 requires distributors and manufacturer representatives to 'appliquer le système de traçabilité défini par la structure en charge de la Réglementation pharmaceutique ou à défaut celui du fabricant' (apply the traceability system defined by the regulation structure or, failing that, the manufacturer's). The device registration decision itself is a database event: under art. 39 the marketing of devices subject to homologation is sanctioned by a five-year renewable marketing authorisation, and the list of devices subject to the homologation procedure is fixed by the regulation structure and must contain at least class B, C and D devices (art. 38). The UEMOA lignes directrices adopted in the decree's visas add a pre-placement declaration step for each supply-chain actor on the annexed 'FORMULAIRE RELATIF AUX DECLARATIONS ET A LA COMMUNICATION DE DISPOSITIFS MEDICAUX'.

Conditions

No UDI issuing agency, UDI carrier format or UDI database submission deadline is prescribed by Décret n° 2023-2419; the decree operates through a nationally-defined identification system and a national 'listing' database.
The traceability and listing duties apply to 'dispositifs médicaux' including in-vitro diagnostic devices (DMDIV); they are not restricted to high-risk classes, although the homologation list must cover at least classes B, C and D (art. 38).

Effective from 2023-12-27

Lignes directrices relatives à l'harmonisation de la réglementation des dispositifs médicaux dans les États membres de l'UEMOA (annexes de la Décision n° 03/2022/CM/UEMOA du 24 juin 2022)

Source is French. The decree text is quoted verbatim below with an English translation; the UEMOA guideline is the supporting source for the pre-placement declaration form that Senegal adopted by the decision cited in the decree's visas.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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

vigilance.national-vigilance-system-and-device-pms

Fact-level verified

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/export control, quality control, after-sales service, control of promotion and advertising, the fight against substandard and falsified devices and illicit sale, inspection of the actors in the supply chain, and matériovigilance. The national vigilance system is instituted by a separate decree: the pharmaceutical regulation structure ensures the prevention and management of risks linked to the use of medicines and other health products, and relies on two vigilance organs created within it — the Comité technique des experts de vigilances and the Commission nationale de Vigilances — and hosts the Centre national de Vigilances, working with regional vigilance coordinators in each regional health directorate.

Conditions

The device decree's 'other health product' formulation includes devices, so the national vigilance system covers them.
The vigilance organ's implementing arrêté is worded predominantly in pharmacovigilance vocabulary, and no device-specific matériovigilance implementing text was located — whether matériovigilance has dedicated operational guidance is unresolved.
Every marketing-authorisation holder for a health product, or its representative, must retain a vigilance-responsible qualified person resident in Senegal (see roles.local-representative-and-resident-vigilance-person).

French original. Translation: 'matériovigilance: surveillance of incidents linked to the use of medical devices' and 'Art. 43. - The post-marketing surveillance system for medical devices comprises in particular: import/export control; quality control; after-sales service; control of promotion and advertising; the fight against substandard and falsified medical devices and illicit sale; inspection of the different actors in the supply chain; matériovigilance.' Read directly from the Journal officiel n° 7704 text layer. The system's organs are Décret n° 2023-2423 arts. 7, 9 and 10, read from the same gazette.

Related structured datasets

Classification systems · 2 records

Open Senegalese IVD classes A, B, C and D (décret n° 2023-2419, art. 18) →

senegal:ivd

Jurisdiction Id

senegal

Domains

Name

Senegalese IVD classes A, B, C and D (décret n° 2023-2419, art. 18)

Description

Senegal classifies in vitro diagnostic devices on a separate table: décret n° 2023-2419, art. 18, gives four classes with their own risk descriptions — A Faible risque individuel et en matière de santé publique, B Risque individuel modéré et/ou faible risque en matière de santé publique, C Risque individuel élevé et/ou modéré en matière de santé publique, D Risque individuel élevé et aussi en matière de santé publique — and arts. 19 to 25 carry the DMDIV rules (transfusion and transmissible agents in class D, blood grouping and typing, autotests, reagents and specimen receptacles in class A, default class B).

Classes

Id
a
Label
Classe A — Faible risque individuel et en matière de santé publique
Normalized Risk Level
low
Id
b
Label
Classe B — Risque individuel modéré et/ou faible risque en matière de santé publique
Normalized Risk Level
medium
Id
c
Label
Classe C — Risque individuel élevé et/ou modéré en matière de santé publique
Normalized Risk Level
high
Id
d
Label
Classe D — Risque individuel élevé et aussi en matière de santé publique
Normalized Risk Level
highest

Regulator

ARP

Official Domains

arp.sn

Source Status

official-source-verified

Reference Sources

Title
UEMOA Décision n° 03/2022/CM/UEMOA, lignes directrices, annexe I-2 (classification des dispositifs médicaux de diagnostic in vitro et règles)
Url
https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7
Reviewed On
2026-09-16
Supports
Annexe I-2 carries the same four-class DMDIV axis with the same risk descriptions and the seven classification rules; the Senegalese DMDIV table reproduces it, and the UEMOA text is where the illustrative examples for each class are published.

Source Title

Décret n° 2023-2419 du 27 décembre 2023, Journal officiel n° 7704 du 24 février 2024, art. 18 (DMDIV class axis) and arts. 19-25 (DMDIV classification rules), pp. 219-232

Source Url

https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

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

senegal:medical-device

Jurisdiction Id

senegal

Domains

medical-device

Name

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

Description

National four-class risk axis: décret n° 2023-2419 du 27 décembre 2023, art. 3, classifies medical devices into four categories by level of risk — A Faible, B Faible-moyen, C Moyen-élevé, D Élevé — and arts. 4 to 17 carry the classification rules for non-invasive, invasive, active and surgical devices. It is the national leg of the IMDRF/WHO model adopted across the UEMOA member states (UEMOA Décision n° 03/2022/CM/UEMOA, annexe I-1), not a projection of the EU MDR classes.

Classes

Id
a
Label
Classe A — Faible
Normalized Risk Level
low
Id
b
Label
Classe B — Faible-moyen
Normalized Risk Level
medium
Id
c
Label
Classe C — Moyen-élevé
Normalized Risk Level
high
Id
d
Label
Classe D — Élevé
Normalized Risk Level
highest

Regulator

ARP

Official Domains

arp.sn

Source Status

official-source-verified

Reference Sources

Title
UEMOA Décision n° 03/2022/CM/UEMOA du 24 juin 2022 portant adoption des lignes directrices relatives à l'harmonisation de la réglementation des dispositifs médicaux dans les États membres de l'UEMOA, annexe I-1
Url
https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7
Reviewed On
2026-09-16
Supports
Annexe I-1 fixes the same four classes A (Faible), B (Faible-moyen), C (Moyen-élevé), D (Élevé) on the IMDRF/WHO classification and carries the rules of application; the Senegalese table is the national adoption of that axis, which is why it matches the UEMOA classes class for class.

Source Title

Source Url

https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Senegal registration →

Country

Senegal

Jurisdiction Id

senegal

Country Code

Flag

🇸🇳

Regulator

Agence sénégalaise de Réglementation pharmaceutique (ARP)

Regulator Abbrev

Agence sénégalaise de Réglementation pharmaceutique (ARP)

Region

africa

Tier

Risk Classification

4-class (A, B, C, D) — IMDRF/WHO model adopted nationally by décret n° 2023-2419, with a separate A/B/C/D table for IVDs

Classes

Id
arp-establishment-agrement
Class Name
Establishment agrément — manufacture, import, registration, export, distribution and maintenance of medical devices
Pathway
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
Official Timeline
Min
3
Max
3
Verification Status
official-verified
Official Source
Title
Arrêté du Ministre de la Santé et de l'Hygiène publique pris en application de l'article 28 du décret n° 2023-2419, fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux — arts. 15-21, 25 and 29 (registered 22 May 2026)
Url
https://arp.sn/wp-content/uploads/2026/06/arrete-fixant-les-modalites-doctroi-dagrement-pour-les-etablissements-de-fabrication-dimportation-denregistrement-dexportation-de-distribution-et-de-maintenance-des-dispositifs-medicaux-1.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
4
Max
6
Notes
Arrêté, art. 29: « L'Agence sénégalaise de Réglementation pharmaceutique statue sur toute demande d'agrément dans un délai de trois (03) mois à compter de la réception d'un dossier complet. Lorsque le dossier est déclaré incomplet, elle notifie au demandeur, dans un délai de deux (02) jours ouvrables, les pièces manquantes. Le délai d'instruction est alors suspendu jusqu'à réception des pièces requises. »
This is the establishment agrément clock. The same arrêté sets no period for the enregistrement or marketing-authorisation phase, so no AMM clock is asserted here.
The agrément states the class or classes of device the establishment may handle (arrêté, arts. 4 and 11), but the three-month period applies whatever the class, so the clock is route-wide rather than class-specific.
Manufacturing and wholesale-import establishments need a prior inspection before the agrément is granted (arrêté, arts. 3 and 8), and the décret requires manufacturers and distributors to observe the good practices in force (art. 41).
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
arsn-ionizing-radiation-authorisation
Class Name
ARSN authorisation — device or installation using ionizing radiation
Pathway
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
Official Timeline
Min
15
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
ARSN, « Combien de temps prend le traitement d'une demande ? » — published treatment time, validity and renewal of a radioprotection authorisation
Url
https://arsn.sn/combien-de-temps-prend-le-traitement-dune-demande/
Accessed Date
2026-09-16
Realistic Timeline
Min
30
Max
60
Unit
days
Notes
ARSN, « Combien de temps prend le traitement d'une demande ? »: « Le délai de traitement varie selon le type d'autorisation, généralement entre 15 et 30 jours après réception d'un dossier complet. » The range is published for authorisations generally, not for a device class, so it is carried as a route-wide clock.
The same page publishes validity and the renewal window: « Une autorisation est généralement valable entre 1 et 5 ans, selon l'activité concernée » and « Le renouvellement doit être demandé au moins 30 jours avant l'expiration de l'autorisation en cours. »
The ARSN states the framework is loi n° 2021-44 du 31 décembre 2021 and defines an autorisation as written permission to carry out non-exempt activities involving ionizing radiation; the operator, not the manufacturer, holds it.
This is not an ARP device-registration clock and does not replace one: a device that generates or contains a radiation source still needs its ARP declaration or marketing authorisation separately.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
EU CE marking / notified-body certificate
Accepted
No
Benefit
Not a substitute for ARP registration, but the technical file, the déclaration de conformité and the test reports behind a CE certificate are the same evidence the ARP requires for the enregistrement dossier.
Authority
WHO prequalification
Accepted
No
Benefit
No reliance route is published: the ARP assesses the dossier itself, and the UEMOA harmonisation leaves the marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).

Key Requirements

Importation of any medical device, whatever its class, needs a prior ARP authorisation (décret n° 2023-2419, art. 36; arrêté, art. 25).
A class B, C or D device needs a marketing authorisation issued by ARP decision and valid five years, renewable; a class A device is filed as a declaration on the basis of a conformity assessment (arrêté, arts. 15-17).
The marketing-authorisation dossier is deposited by the applicant through its local representative (arrêté, art. 18), so a foreign manufacturer needs a Senegal-based representative.
Renewal must be filed 120 days before the authorisation expires (arrêté, art. 21).
Technical documentation, identification and instructions must be established in the official national language, French (décret, art. 34).
A certificat de mise en service is issued by the ARP before any first use of a high-risk device, in particular classes C and D (décret, art. 40).
The ARP fixes the national list of devices subject to homologation and it must contain at least classes B, C and D (décret, art. 38).
Radioelectrical equipment needs a prior ARTP agrément before use on Senegalese territory (loi n° 2018-028, art. 70); the ARTP procedure publishes dossier requirements and fees but no review period.
A device using ionizing radiation needs an ARSN authorisation held by the operator, for which the ARSN publishes generally 15-30 days after a complete dossier.

Local Rep Required

Yes

Local Rep Name

Représentant local (mandated by the manufacturer)

Mdsap Accepted

Mdsap Benefit

No Senegalese reliance instrument was read, so no MDSAP or ISO 13485 shortcut is asserted; quality-system evidence can support the essential-requirements checklist filed with the dossier.

Registration Validity

5 years for a class B, C or D marketing authorisation (renewable); the class A and B declaration line in the tariff carries no stated validity

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Décret n° 2023-2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux, Journal officiel n° 7704 du 24 février 2024, arts. 34, 36, 38, 39 and 40
Url
https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf
Accessed Date
2026-09-16
Title
Arrêté du Ministre de la Santé et de l'Hygiène publique pris en application de l'article 28 du décret n° 2023-2419, fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux — arts. 15-21, 25 and 29 (registered 22 May 2026)
Url
https://arp.sn/wp-content/uploads/2026/06/arrete-fixant-les-modalites-doctroi-dagrement-pour-les-etablissements-de-fabrication-dimportation-denregistrement-dexportation-de-distribution-et-de-maintenance-des-dispositifs-medicaux-1.pdf
Accessed Date
2026-09-16
Title
ARTP procédure d'agrément d'équipement radioélectrique — requirements under art. 70 of loi n° 2018-028 du 12 décembre 2018 portant Code des Communications électroniques
Url
https://artp.sn/sites/default/files/documents/procedure_dagrement_dequipement_radioelectrique_0.pdf
Accessed Date
2026-09-16
Title
ARSN, « Combien de temps prend le traitement d'une demande ? » — published treatment time, validity and renewal of a radioprotection authorisation
Url
https://arsn.sn/combien-de-temps-prend-le-traitement-dune-demande/
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Agence sénégalaise de Réglementation pharmaceutique (ARP). Appoint a Représentant local (mandated by the manufacturer).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Agence sénégalaise de Réglementation pharmaceutique (ARP) including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Agence sénégalaise de Réglementation pharmaceutique (ARP) reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Agence sénégalaise de Réglementation pharmaceutique (ARP) may issue questions.
Duration
3 months
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Agence sénégalaise de Réglementation pharmaceutique (ARP) issues Senegal market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Senegal fees →

Jurisdiction Id

senegal

Country

Senegal

Country Code

Authority

Agence sénégalaise de Réglementation pharmaceutique (ARP)

Low Risk Local

Min: 10000
Max: 10000
Currency: XOF
Per Product: Yes

High Risk Local

Min: 1000000
Max: 1000000
Currency: XOF
Per Product: Yes

Details

Id
class-d-enregistrement
Item
Marketing authorisation — Class D device, registration (enregistrement)
Currency
XOF
Amount Local
1000000
Amount Local Formatted
XOF 1,000,000
Frequency
Per product
Notes
Section 6, row « Dispositif Médical de classe D »; the authorisation is valid five years and renewable (arrêté, art. 17).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-d-renouvellement
Item
Marketing authorisation — Class D device, renewal (renouvellement)
Currency
XOF
Amount Local
500000
Amount Local Formatted
XOF 500,000
Frequency
Per product, every 5 years
Notes
Renewal must be filed 120 days before expiry (arrêté, art. 21).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-d-variation-majeure
Item
Marketing authorisation — Class D device, major variation
Currency
XOF
Amount Local
1000000
Amount Local Formatted
XOF 1,000,000
Frequency
Per variation
Notes
Décret n° 2023-2419, art. 20 makes any modification of the dossier subject to a variation request.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-d-variation-mineure
Item
Marketing authorisation — Class D device, minor variation
Currency
XOF
Amount Local
250000
Amount Local Formatted
XOF 250,000
Frequency
Per variation
Notes
Section 6, « Variation mineure » row for class D.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-c-enregistrement
Item
Marketing authorisation — Class C device, registration (enregistrement)
Currency
XOF
Amount Local
500000
Amount Local Formatted
XOF 500,000
Frequency
Per product
Notes
Section 6, row « Dispositif Médical de classe C ».
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-c-renouvellement
Item
Marketing authorisation — Class C device, renewal (renouvellement)
Currency
XOF
Amount Local
250000
Amount Local Formatted
XOF 250,000
Frequency
Per product, every 5 years
Notes
The tariff's validity cell for the C and D rows reads « 05 ANS ».
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-c-variation-majeure
Item
Marketing authorisation — Class C device, major variation
Currency
XOF
Amount Local
500000
Amount Local Formatted
XOF 500,000
Frequency
Per variation
Notes
Section 6, « Variation majeure » row for class C.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
class-c-variation-mineure
Item
Marketing authorisation — Class C device, minor variation
Currency
XOF
Amount Local
250000
Amount Local Formatted
XOF 250,000
Frequency
Per variation
Notes
Section 6, « Variation mineure » row for class C.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
classes-a-and-b-declaration
Item
Class A and class B devices — declaration (déclaration de dispositifs médicaux)
Currency
XOF
Amount Local
10000
Amount Local Formatted
XOF 10,000
Frequency
Per product
Notes
The tariff's validity cell for this row reads « aucun délai » (no time limit). The tariff groups class A and class B under a declaration while the arrêté requires a marketing authorisation for class B (arts. 15-16); the two instruments are not reconciled here.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
local-industry-enregistrement
Item
Locally manufactured device — registration (cas des industries locales)
Currency
XOF
Amount Local
500000
Amount Local Formatted
XOF 500,000
Frequency
Per product
Notes
Section 6 carries a separate schedule for « CAS DES INDUSTRIES LOCALES » with five-year validity.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
local-industry-renouvellement
Item
Locally manufactured device — renewal (cas des industries locales)
Currency
XOF
Amount Local
500000
Amount Local Formatted
XOF 500,000
Frequency
Per product, every 5 years
Notes
Local-industry renewal is priced at the same amount as local-industry registration.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
local-industry-variation-majeure
Item
Locally manufactured device — major variation (cas des industries locales)
Currency
XOF
Amount Local
250000
Amount Local Formatted
XOF 250,000
Frequency
Per variation
Notes
Section 6, local-industry schedule.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16
Id
local-industry-variation-mineure
Item
Locally manufactured device — minor variation (cas des industries locales)
Currency
XOF
Amount Local
125000
Amount Local Formatted
XOF 125,000
Frequency
Per variation
Notes
Section 6, local-industry schedule.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Source Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Source Effective Date
2025-11-18
Verified On
2026-09-16

Notes

Amounts are in CFA francs (XOF), which has no subunit; the tariff publishes whole francs.
The schedule also prices a late renewal as a formula rather than an amount — « 1% du montant du renouvellement par jour de retard » for classes C and D — and publishes no numeric amount for it, so it is not stated here as a fee row.
Radio-equipment agrément fees are charged separately by the ARTP under art. 70 of loi n° 2018-028: XOF 59,000 dossier fee and XOF 236,000 agrément fee per equipment, VAT included, per the ARTP procedure cited in the certification dataset.
Décret n° 2023-2419, art. 39 makes a technical evaluation by a comité d'experts and a validation by a commission nationale part of homologation, but the schedule prices no separate expert-committee or commission fee.
Class B, C and D marketing authorisations are issued by ARP decision and are valid five years; the class A and B declaration line carries no stated validity period.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Décret n° 2025-1833 du 18 novembre 2025 fixant les redevances issues de la régulation du secteur pharmaceutique et leurs modalités de perception, Journal officiel n° 7871 (numéro spécial) du 29 décembre 2025, section 6 « Homologation des dispositifs médicaux », pp. 1660-1661
Url
https://arp.sn/wp-content/uploads/2026/01/Decret-n%C2%B0-2025-1833-du-18-novembre-2025-fixant-les-redevances-issues-de-la-regulation-pharmaceutique-et-leurs-modalites-de-perception.pdf
Effective Date
2025-11-18
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Senegal certifications →

Slug

senegal

Market

Senegal

Confidence

high

Schemes

Id
arp-emc-essential-requirements
Name
ARP essential requirements — electromagnetic compatibility
Category
emc
Status
Included In Medical Registration
Object
Medical Device
Note
Décret n° 2023-2419, annexe I, sections B9.5 and B9.6, require devices to be designed and manufactured so as to reduce as far as possible the risk of creating electromagnetic interference with other equipment in the usual environment and to ensure an adequate level of intrinsic immunity to electromagnetic disturbance. Compliance is assessed inside the ARP enregistrement or declaration of conformity, which the arrêté taken under art. 28 of the décret routes through an administrative and technical evaluation (arts. 15-16); Senegal issues no separate EMC certificate, so the trigger is evidence in the device dossier rather than a second approval.
Source Urls
https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf
Source Binding
reviewed
Id
arp-electrical-safety-essential-requirements
Name
ARP essential requirements — protection against electrical hazards
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Medical Device
Note
Décret n° 2023-2419, annexe I, section B9.7, requires devices to be designed and manufactured to avoid as far as possible the risk of accidental electric shock to the patient, the user or any other person, both in normal use and in the event of a single fault, and B9.1 to B9.4 carry the corresponding active-device requirements, including alarms for monitored clinical parameters. There is no Senegalese electrical-safety certificate: the requirement is one of the essential requirements against which the ARP assesses conformity for the marketing authorisation or the class A declaration.
Source Urls
https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf
Source Binding
reviewed
Id
artp-radio-equipment-agrement
Name
ARTP prior agrément for radioelectrical equipment
Category
Radio Spectrum
Status
Mandatory Pre Market
Object
Radio Equipment
Note
The ARTP procedure recalls that "l'article 70 de la loi n° 2018-028 du 12 décembre 2018 portant Code des Communications électroniques, stipule que tout équipement radioélectrique destiné à être utilisé sur le territoire national doit faire l'objet d'un agrément préalable délivré par l'ARTP". The dossier requires the application form, the manufacturer's details, a certificate of origin, a document attesting an existing agrément in the country of manufacture, a déclaration de conformité, test reports, technical documentation in French and a sample where necessary, and the procedure publishes "Frais de dossier d'un montant de 59 000F CFA TTC pour chaque équipement" and "Frais d'agrément d'un montant de 236 000F CFA TTC pour chaque équipement". A device with a radio module therefore needs an ARTP agrément before use in Senegal, separately from its ARP registration.
Source Urls
https://artp.sn/procedure-dagrement-dequipement-radioelectrique-0
https://artp.sn/sites/default/files/documents/procedure_dagrement_dequipement_radioelectrique_0.pdf
Source Binding
reviewed
Id
arsn-ionizing-radiation-authorisation
Name
ARSN authorisation for activities involving ionizing radiation
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Radiation Source Or Installation
Note
The ARSN states that the framework is "la loi n° 2021-44 du 31 décembre 2021 relative à la radioprotection, la sûreté et la sécurité nucléaires et aux garanties" and defines an autorisation as "une permission accordée par écrit à un exploitant par l'ARSN pour exécuter des activités non exemptées et mettant en jeu des rayonnements ionisants", with application forms published for importation, exportation, détention et utilisation, and transport. A device that generates or contains a radiation source therefore needs an ARSN authorisation held by the operator in addition to its ARP registration; the ARSN publishes no separate device type approval.
Source Urls
https://arsn.sn/reglementation/
https://arsn.sn/autorisation/
Source Binding
reviewed
Id
arp-prior-import-authorisation
Name
ARP prior authorisation for the importation of medical devices
Category
Import Conformity
Status
Mandatory At Import
Object
Medical Device
Note
Décret n° 2023-2419, art. 36: "L'importation de tout dispositif médical, quelle que soit sa classe d'appartenance est subordonnée à une autorisation préalable de la structure en charge de la Réglementation pharmaceutique", a rule the ARP arrêté repeats in its art. 25 for every medical device. The import authorisation is separate from the marketing authorisation — the décret lets the ARP withdraw, suspend or cancel it on a reasoned decision (art. 37) — and the conditions for granting it are fixed by arrêté of the Minister of Health.
Source Urls
https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf
https://arp.sn/wp-content/uploads/2026/06/arrete-fixant-les-modalites-doctroi-dagrement-pour-les-etablissements-de-fabrication-dimportation-denregistrement-dexportation-de-distribution-et-de-maintenance-des-dispositifs-medicaux-1.pdf
Source Binding
reviewed

Official Sources

Authority
ARP / Ministère de la Santé et de l'Hygiène publique
Topic
Décret n° 2023-2419 du 27 décembre 2023, Journal officiel n° 7704 du 24 février 2024 — device classes, classification rules and the essential requirements in annexe I
Url
https://arp.sn/wp-content/uploads/2024/04/Journal-officiel-Numero-7704-DU-SAMEDI-24-FEVRIER-2024.pdf
Authority
ARP / Ministère de la Santé et de l'Hygiène publique
Topic
Arrêté pris en application de l'article 28 du décret n° 2023-2419 fixant les modalités d'octroi d'agrément pour les établissements de fabrication, d'importation, d'enregistrement, d'exportation, de distribution et de maintenance des dispositifs médicaux (registered 22 May 2026)
Url
https://arp.sn/wp-content/uploads/2026/06/arrete-fixant-les-modalites-doctroi-dagrement-pour-les-etablissements-de-fabrication-dimportation-denregistrement-dexportation-de-distribution-et-de-maintenance-des-dispositifs-medicaux-1.pdf
Authority
ARTP
Topic
Procédure d'agrément d'équipement radioélectrique — dossier requirements and fees under art. 70 of loi n° 2018-028
Url
https://artp.sn/procedure-dagrement-dequipement-radioelectrique-0
Authority
ARTP
Topic
Procédure d'agrément d'équipement radioélectrique (PDF)
Url
https://artp.sn/sites/default/files/documents/procedure_dagrement_dequipement_radioelectrique_0.pdf
Authority
ARSN
Topic
Radioprotection legal framework — loi n° 2021-44 du 31 décembre 2021 relative à la radioprotection, la sûreté et la sécurité nucléaires et aux garanties
Url
https://arsn.sn/reglementation/
Authority
ARSN
Topic
Autorisation — scope, application forms and the ARSN's published processing time
Url
https://arsn.sn/autorisation/

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Confirm the current Agence sénégalaise de Réglementation pharmaceutique (ARP) pathway, evidence, and local-role details for the actual device before filing.

Pricing

Advertising, claims & promotion

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

Approval validity & renewal

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

Authority & regime

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

Change control

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

Classification rules

Four risk classes A/B/C/D, with rule-based classification and IVD escalation to class D

Clinical investigation & performance

Clinical evaluation for all devices and clinical investigations on human subjects

Device definition & scope

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

Dossier requirements

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

Economic-operator roles

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

Establishment, import & distribution

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

Fees

Device registration fees: class D 1 000 000, class C 500 000 FCFA; class A and B declaration 10 000 FCFA

Label, IFU & language

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

Legal basis & guidance

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

Manufacturer PMS

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

QMS, audit & inspection

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

Recall, FSCA & market surveillance

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

Registration pathways

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

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

Import of ANY medical device, whatever its class, needs a prior ARP authorisation

Reliance & recognition

Senegal approvals and evidence in other markets (0 records)

Prior approvals and evidence for Senegal (4 records)

WHO prequalification

EU CE marking / notified-body certificate

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

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

Review clocks

ARP decides on an agreement application within three months; incomplete dossiers notified within two working days

Special access & derogation

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

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)

For public-health reasons, exceptional derogations in the form of special authorisations (temporary use authorisations) may be granted for categories of medicines and other health products; modalities by ministerial order (Loi 2023-06, Art. 134)

Standards, testing & ancillary approvals

Décret 2023-2419 defines the certificate of conformity (issued by a recognised conformity assessment body), the manufacturer's declaration of conformity and the conformity assessment body (Art. 2)

Placing on the market of devices subject to homologation requires a conformity evaluation against the essential requirements, reviewed administratively by ARP, technically by an expert committee and validated by a national commission (Art. 39)

Essential requirements for quality, safety and performance are fixed in Annexe 1 of Décret 2023-2419 (Art. 26)

ARP may base market-surveillance decisions on analytical results and regulatory decisions of maturity-level-3 authorities and recognises test results of accredited or WHO-prequalified laboratories (Décret 2023-2420, Art. 14)

Submission communications & appeal

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

UDI, listing & traceability

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

Vigilance & incident reporting

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

Related structured datasets

More Senegal medical device resources