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AIRP · structured requirements

🇨🇮 Côte d'Ivoire medical device regulatory data

Explore the medical device requirements currently available for Côte d'Ivoire, organized by topic and linked to official sources.

38 facts24 dimensions12 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

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

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AIRP is charged with regulating promotion and publicity for medical devices

advertising.authority-must-regulate-device-promotion-and-publicity
Fact-level verified

The competent national regulatory authority is charged with applying the regulation on promotion and publicity relating to medical devices, and the mandatory market-surveillance system must include a control of promotion and publicity. In Côte d'Ivoire that authority is the AIRP.

Conditions
  • The instrument requires the authority to apply a promotion/publicity regulation; it does not itself set the substantive advertising rules, which are national.
  • The AIRP's own advertising-control machinery (a commission for the control of advertising and periodic advertising-authorisation sessions) is published on its official document index as image-only PDFs and spreadsheet forms, so no article-level rule is taken from it.

Source is French; verbatim passage and translation below.

Approval validity & renewal

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

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Autorisation de Commercialisation valid five years, renewable; renewal fee is half the base fee

validity.five-years-renewable
Fact-level verified

The Autorisation de Commercialisation obtained through the conformity assessment is valid for a renewable period of five years. Renewal is a distinct, fee-scheduled step: the schedule carries a renewal line at half the base registration fee for each class (25 000 / 125 000 / 250 000 / 500 000 / 1 250 000 CFA francs).

Conditions
  • The renewal dossier contents are not set out in the published procedure; only the fee is scheduled.
  • The AIRP publishes no renewal window or deadline in this procedure document.

French original. Translation: 'It is sanctioned by the issue of a Marketing Authorisation valid for a renewable period of five (5) years.' Read by OCR of the official scanned AIRP PDF. Note that this is the same passage that anchors reliance.no-device-reliance-route; the two facts read different halves of it.

Authority & regime

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

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AIRP is the competent authority for medical devices, as the UEMOA-designated pharmaceutical regulatory authority

authority.airp-competence-over-devices
Fact-level verified

Device marketing authorisations in Côte d'Ivoire are issued by the Autorité Ivoirienne de Régulation Pharmaceutique (AIRP). The AIRP acts as the 'autorité de réglementation pharmaceutique' to which UEMOA Décision n° 03/2022/CM/UEMOA assigns the delivery of device marketing authorisations and/or putting-into-service authorisations in each member state; the AIRP's own device procedure is issued under that decision and is signed by its Directeur Général. Applications are addressed to the Directeur Général of the AIRP, and the AIRP also agrees the Ivorian import and commercialisation companies that may apply on a manufacturer's behalf.

Conditions
  • The regional instrument requires member states to put the institutional and legal framework in place within 24 months of its entry into force; the decision was signed at Dakar on 24 June 2022.
  • Côte d'Ivoire's device regime is therefore administered by the pharmaceutical regulator rather than by a separate device agency — the same pattern as Senegal and Morocco.

French original. Translation: 'In each member state of the Union, the marketing authorisations and/or putting-into-service authorisations for medical devices are delivered by the pharmaceutical regulatory authorities. The pharmaceutical regulatory authorities take the necessary measures to ensure the quality and safety of these products, in accordance with the guidelines referred to in Article 1 of this Decision. Manufacturers, representatives, importers, exporters and distributors of medical devices must comply with the regulatory system put in place by this Article.' Read directly from the AIRP-published copy of the decision (scanned; OCR at 200 dpi with Tesseract fra).

Change control

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

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Post-authorisation changes are handled as major or minor variations on a published fee schedule

change.major-and-minor-variations
Fact-level verified

The AIRP fee schedule prices two categories of post-authorisation change — major variation (variation majeure) and minor variation (variation mineure) — at every device class, with the major-variation fee equal to the full base registration fee and the minor-variation fee at a fraction of it. This establishes that a variation procedure exists and what it costs, but the procedure document does not state the criteria distinguishing a major from a minor variation, nor the documents or the decision clock for either.

Conditions
  • No definition of 'variation majeure' or 'variation mineure' appears in the published procedure; a separate AIRP decision fixing the variation dossier is not published on the pages located in this round.
  • The existence and cost of the variation route are verified; its procedure is not.

French original table lines. Translation: 'Major variation' and 'Minor variation', priced at 50 000 / 250 000 / 500 000 / 1 000 000 / 2 500 000 and 10 000 / 25 000 / 50 000 / 100 000 / 250 000 CFA francs across the five class columns. Read by OCR of the official scanned AIRP PDF.

Classification rules

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

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UEMOA four-class device classification and the AIRP tariff column for class D IVDs

classification.four-classes-and-dmdiv
Fact-level verified

The AIRP applies the UEMOA four-class risk classification to medical devices — class A (I), class B (IIA), class C (IIB) and class D (III) — with a single parallel tariff column for in-vitro diagnostic medical devices (DMDIV) headed « DMDIV de Classe D (III) ». The application letter must state the device's classification according to the classification retained by the UEMOA regulation, and the fee schedule is banded on these classes. A separate 10 000 CFA franc line covers the declaration of laboratory reagents for medical biology.

Conditions
  • The class labels in the AIRP fee table are given in the UEMOA form with the EU-equivalent class in brackets: Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III); the fifth column is headed « DMDIV de Classe D (III) », not '(II)'.
  • The classification RULES themselves are in the UEMOA guidelines annexes I-1 (devices) and I-2 (DMDIV), which the decision adopts; the AIRP procedure document reproduces the class bands but not the rules.

French original column headings: 'DISPOSITIFS MEDICAUX / DISPOSITIFS MEDICAUX DE DIAGNOSTIC IN VITRO (DMDIV)' then 'Classe A (I)', 'Classe B (IIA)', 'Classe C (IIB)', 'Classe D (III)', 'DMDIV Classe D (II)'. The classification-in-the-application requirement is at II.2.1 item 1: 'y compris sa classification conformément à celle retenue par la réglementation UEMOA'. Read by OCR of the official scanned AIRP PDF.

Clinical investigation & performance

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

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Clinical evaluation may rest on literature review and clinical experience

clinical.evaluation-accepts-literature-and-clinical-experience
Fact-level verified

For all medical devices, the demonstration of conformity with the essential principles includes a clinical evaluation carried out in accordance with the competent authority's guidelines. The clinical evaluation is to examine clinical data in the form of clinical investigation reports and/or reports or reviews of the literature and clinical experience, in order to establish that a favourable benefit/risk ratio exists for the device. Clinical investigations on human subjects are to be conducted in the spirit of the Declaration of Helsinki, from the identification of the need and justification for the study through to publication of the results, and certain countries may have specific regulatory requirements for protocol review before the study or for informed consent.

Conditions
  • The clause requires a clinical evaluation but does not require the underlying data to be generated locally; reports/reviews of the literature and clinical experience are named as acceptable forms of clinical data.
  • No express exemption from local investigation is stated in this text.

Source is French; verbatim passage and translation below.

Device definition & scope

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

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Harmonised UEMOA definition of medical device, IVD and software scope

scope.harmonised-device-ivd-accessory-software-definition
Fact-level verified

Côte d'Ivoire applies, as a UEMOA member state, the harmonised definition of a medical device: any instrument, apparatus, equipment, material or other article, used alone or in combination, including the software necessary for its correct operation, intended by the manufacturer for use in humans for (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap; (iii) investigation, replacement or modification of anatomy or of a physiological process; or (iv) conception control — and whose principal intended action in or on the human body is not obtained by pharmacological, immunological or metabolic means, although its function may be assisted by such means. Products specifically intended for cleaning, disinfecting or sterilising such devices are also deemed medical devices. A separate definition covers the in-vitro diagnostic medical device (DMDIV): a reagent, calibrator, control material, kit, instrument, apparatus, equipment, software or system, used alone or in combination, intended by the manufacturer for in-vitro examination of samples from the human body, including blood and tissue donations, to provide information on a physiological or pathological state, on a congenital anomaly, on predisposition to a medical condition or disease, to determine safety and compatibility with potential recipients, or to monitor therapeutic measures. Products intended for general laboratory use are not IVDs unless, given their characteristics, they are specifically intended by their manufacturer for in-vitro diagnostic examination.

Conditions
  • This is the regional harmonisation instrument applied by each UEMOA member state's national regulatory authority; the list of devices actually subject to the homologation procedure is fixed by each member state and must cover at least classes B, C and D.
  • Software is in scope as 'the software necessary for the correct operation' of a device; the text does not separately define standalone software as a device.
  • Accessories are not defined as a standalone category in this text; they fall within 'instrument, apparatus, equipment, material or other article... used in combination'.
Autorité Ivoirienne de Régulation Pharmaceutique – AIRP (Portail Web d'Informations Commerciales de Côte d'Ivoire)

Source is French; the passage is quoted verbatim below with an English translation. National applicability in Côte d'Ivoire: the AIRP/GUCE portal (supporting source) places 'les dispositifs médicaux' and IVD laboratory reagents/consumables inside the national category 'produits pharmaceutiques' regulated under loi n° 2017-541.

Dossier requirements

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

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Seven administrative items in hard copy plus a technical file on CD/DVD-ROM

dossier.administrative-and-technical-items
Fact-level verified

The device marketing-authorisation dossier has two parts. The administrative part, in hard copy, comprises: the application in four copies addressed to the AIRP Directeur Général, stating the manufacturer's name and registered office, the applicant's name and address, the manufacturer's representative where applicable, and the device's trade name, presentation, use, reference and UEMOA classification; a certified copy of the conformity attestation obtained under the international procedures recognised by the AIRP; a copy of any good-manufacturing-practice certificate in force for medical devices; a document attesting first placing on the market in the country of origin; a valid batch conformity certificate; an attestation of the wholesale ex-tax price (PGHT) in three copies, in CFA francs, setting out the price structure (ex-works or supplier ex-tax price in the origin country, proposed PGHT in CFA francs, and the public retail price in both the origin country and Côte d'Ivoire); and proof of payment of the homologation fees. The technical part is filed electronically on CD-ROM or DVD-ROM and comprises stability-study results where applicable, a risk-management plan for the device across its life cycle, documentation with a checklist demonstrating conformity with the essential requirements and the corresponding standards, where necessary documentation indicating the requirements not applicable to the device, a summary of the device's technical characteristics/specifications in French, and the labelling model and instructions-for-use model.

Conditions
  • All documents in the application must be in French and presented in a box or binder bearing the product's trade name, the laboratory's name, the name of the representation agency and a telephone contact.
  • Documents are supplied in three copies: one hard copy and two electronic versions.
  • The file must be accompanied by an original cheque plus three copies, drawn on a crossed bank cheque to the order of 'AUTORITÉ IVOIRIENNE DE REGULATION PHARMACEUTIQUE'.
  • On the expert committee's advice, an additional technical evaluation may be required, at the applicant's expense.

French original of the technical-file heading and the French-language rule: 'II.2.2 Un dossier technique en version électronique (CD-ROM ou DVD-ROM)' and 'NB : Tous les documents de cette demande doivent être en français et présentés dans un coffret ou dans un classeur portant mention du nom commercial du produit, le nom du laboratoire, le nom de l'agence de représentation et un contact téléphonique.' Read by OCR of the official scanned AIRP PDF.

Economic-operator roles

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

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Only manufacturers, or AIRP-agreed Ivorian import/commercialisation companies mandated by the manufacturer, may apply

roles.applicant-must-be-airp-agreed-ivorian-company
Fact-level verified

Two categories of person may apply for a device marketing authorisation in Côte d'Ivoire: manufacturers of medical devices; and Ivorian import and commercialisation companies that are agreed by the AIRP, mandated by the manufacturer, and applying for registration on the manufacturer's behalf. A foreign manufacturer with no Ivorian presence therefore cannot file directly — it must mandate an AIRP-agreed Ivorian company. The application letter must state the name and registered-office address of the manufacturer, of the applicant, and of the manufacturer's representative where there is one.

Conditions
  • The manufacturer remains identified in the application; the Ivorian company is the applicant and registration holder.
  • The agreement (agrément) of the Ivorian import/commercialisation company is a precondition, so the choice of local partner is gated by the AIRP, not free.

French original. Translation: 'Manufacturers of medical devices; Import and commercialisation companies for medical devices, agreed by the AIRP, mandated by the manufacturer and applying for registration on the manufacturer's behalf.' Read by OCR of the official scanned AIRP PDF. The application-letter requirements are at II.2.1 item 1.

Establishment, import & distribution

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

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Authorisation required to manufacture, import, export, distribute or sell devices

establishment.authorisation-required-for-manufacture-import-distribution-sale
Fact-level verified

Manufacture, import, export, distribution and sale of medical devices are conditional on an authorisation issued by the competent national authority; the conditions for granting a manufacturing, import, export, distribution and sale authorisation are specified by the competent authority of each UEMOA member state. In Côte d'Ivoire that competent authority is the AIRP.

Conditions
  • Licence categories, application content, fees and validity periods are set at member-state level, not by the harmonised text.
  • The instrument does not say whether a foreign manufacturer's own licence is recognised; the establishment licence is a national act.
Autorité Ivoirienne de Régulation Pharmaceutique – AIRP (Portail Web d'Informations Commerciales de Côte d'Ivoire)

Source is French; verbatim passage and translation below. National applicability is evidenced by the AIRP/GUCE portal, which states that the import/export regime applies to establishments holding an AIRP autorisation d'exercice.

Fees

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

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Fee schedule by class A/B/C/D and DMDIV, halved for devices manufactured in the UEMOA area

fees.schedule-by-class-and-uemoa-reduction
Fact-level verified

The base fee for device registration is fixed by type, class and presentation according to risk level. In CFA francs: declaration 10 000 for every class; registration (base fee) 50 000 (class A), 250 000 (B), 500 000 (C), 1 000 000 (D), 2 500 000 (DMDIV class D); major variation the same as the base fee at each class; minor variation 10 000 / 25 000 / 50 000 / 100 000 / 250 000; renewal 25 000 / 125 000 / 250 000 / 500 000 / 1 250 000. The base fee is reduced by half for medical devices manufactured within the UEMOA area. Payment is by crossed bank cheque to the order of the Autorité Ivoirienne de Régulation Pharmaceutique. A separate line priced at 10 000 covers the declaration of laboratory reagents for medical biology.

Conditions
  • The UEMOA half-reduction applies to the BASE registration fee for devices manufactured in the UEMOA space — it is a regional-manufacturing preference, not a reliance mechanism.
  • Only the base registration fee is stated to be halved; the source does not extend the reduction to variations or renewal.
  • A further technical-evaluation fee may be charged on the expert committee's advice, at the applicant's expense, with no published scale.

French original. Translation: 'The amount of the base fee is fixed by type, by class and by presentation according to the level of risk.' and 'The amount of the base fee is reduced by half for Medical Devices manufactured within the UEMOA area.' Amounts read from the fee table by OCR of the official scanned AIRP PDF; the table's column headings are 'Classe A (I)', 'Classe B (IIA)', 'Classe C (IIB)', 'Classe D (III)' and 'DMDIV Classe D (II)'. 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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Every document in the application must be in French, including the technical summary and the labelling and IFU models

label.all-documents-in-french
Fact-level verified

All documents of the device marketing-authorisation application must be in French and presented in a box or binder bearing the product's trade name, the laboratory's name, the name of the representation agency and a telephone contact. Specifically, the summary of the device's characteristics and technical specifications must be in French, and the labelling model and the instructions-for-use model are filed with the application. In addition, three samples of the final sale model must be presented in French and have a validity of at least twelve months, accompanied by the certificates of analysis.

Conditions
  • The language rule is stated for the DOCUMENTS of the application; the source states the samples must be 'présentés en français', so French is also the required presentation language for the marketed sample.
  • No separate provision on the language of the marketed label after grant was located in the procedure document; the requirement is expressed through the dossier.

French original. Translation: 'Three (03) samples of the final sale model presented in French having a validity of at least twelve (12) months accompanied by the certificates of analysis.' and 'NB: All the documents of this application must be in French and presented in a box or in a binder bearing mention of the product's trade name, the laboratory's name, the name of the representation agency and a telephone contact.' Read by OCR of the official scanned AIRP PDF.

Manufacturer PMS

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

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Life-cycle vigilance system and manufacturer post-market risk-reduction duties

pms.lifecycle-vigilance-system-and-manufacturer-postmarket-duties
Fact-level verified

The national regulatory authority is required to develop and operate a vigilance system throughout the whole life cycle of the medical device, 'life cycle' being defined as all phases of a device's life from its initial design through to its decommissioning and disposal. The manufacturer's post-market obligations are: after investigation, immediately to inform and place at the disposal of the competent authorities every adverse-event report concerning a device that it receives or holds, together with the safety corrective measures implemented; and to cooperate, at the competent authority's request, in implementing any measure adopted in order to reduce as far as possible the risks presented by a device placed on the market. The same cooperation duty applies to the manufacturer's representative, to importers/exporters and to distributors.

Conditions
  • The harmonised text imposes a duty to operate vigilance across the life cycle but specifies no periodic reporting interval (no PSUR/PMS-plan cadence, no trend-reporting period) — see the D21 unresolved note.
  • The immediate adverse-event notification duty is stated here in the same article as the risk-reduction cooperation duty; it is reported separately under D22 as the vigilance incident-reporting rule.

Source is French; verbatim passage and translation below.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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The listing declaration form is published on the AIRP website; applications address the Directeur Général

forms.declaration-form-on-airp-site
Fact-level verified

The medical-device listing declaration form is published on the AIRP website at www.airp.ci. Marketing-authorisation applications are addressed in four copies to the Directeur Général of the AIRP, and the dossier (one hard copy plus two electronic versions, plus the original cheque and three copies) is submitted to the agency.

Conditions
  • The AIRP site is at www.airp.ci; the device procedure and its forms are served from the AIRP's document platform.

French original. Translation: '...on the basis of a declaration form (available on the site www.airp.ci).' Read by OCR of the official scanned AIRP PDF. Marked verified because the source names the portal explicitly; the individual form files were not enumerated in this round.

QMS, audit & inspection

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

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Inspection carried out by sworn AIRP pharmacy inspectors with seizure powers

inspection.sworn-airp-pharmacy-inspectors-powers
Fact-level verified

Pharmaceutical inspection in Côte d'Ivoire is exercised by sworn pharmacy inspectors of the AIRP, who are charged with carrying out operations of control, inspection, investigation, recording of offences and seizure. The AIRP's organisation decree also establishes a directorate responsible for inspection and market surveillance of the pharmaceutical sector, and a directorate responsible for processing applications for establishment licences and other authorisations.

Conditions
  • The decree is drafted for the pharmaceutical sector and does not name medical devices; national device coverage rests on the AIRP/GUCE glossary, which places devices inside 'produits pharmaceutiques'.
  • The power is territorial: the text confers no express power to inspect a manufacturing site located outside Côte d'Ivoire.
Autorité Ivoirienne de Régulation Pharmaceutique – AIRP (Portail Web d'Informations Commerciales de Côte d'Ivoire)

Source is French; verbatim passage and translation below. The PDF has a clean text layer with accents preserved and the quoted sentence is contiguous.

Manufacturer must comply with device GMP and keep the conformity documentation

qms.device-gmp-conformity-and-technical-documentation-duty
Fact-level verified

The manufacturer must comply with and apply the good manufacturing practice standards for medical devices in force; must draw up the technical documentation required for conformity assessment, identification and use of the device in the official language of the member state's competent authority; must establish a declaration of conformity and affix the conformity marking once conformity with the applicable requirements has been demonstrated; and must keep the technical documentation and the declaration of conformity for the life cycle of the product concerned. The same obligations extend to any person who assembles, packages, processes, refurbishes and/or labels one or more prefabricated products, or assigns them a device destination, in order to place them on the market or put them into service under its own name.

Conditions
  • The instrument requires conformity with GMP but does not state the conditions under which a foreign QMS or ISO 13485 certificate would be accepted in place of a national audit — see the D12 unresolved note.
  • 'Conformity marking' is the UEMOA marking; the text does not equate it with the CE marking.

Source is French; verbatim passage and translation below.

Recall, FSCA & market surveillance

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

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Mandatory market-surveillance system components and safe-disposal mechanism

market-surveillance.system-components-and-safe-disposal-duty
Fact-level verified

The competent authority of each UEMOA member state must set up a market-surveillance system for medical devices including in-vitro diagnostics, referring to the AMDF and WHO guidelines. The system must comprise: an import/export control; a quality control; a control of promotion and publicity; a plan to combat counterfeiting, falsification and illicit sale; an inspection of the various actors in the supply chain; and a vigilance component. The competent authority must also put in place a mechanism for the safe management and disposal of non-functional or end-of-life medical devices.

Conditions
  • The components are mandatory minima; procedures and implementation modalities are defined by each competent authority under WHO guidelines.
  • Côte d'Ivoire's own implementing decisions on recall/withdrawal/suspension/destruction are image-only scans (see the D23 unresolved note).

Source is French; verbatim passage and translation below.

AIRP instrument fixing batch recall, withdrawal, suspension and destruction

recall.airp-instrument-on-batch-recall-withdrawal-suspension-destruction
Fact-level verified

The AIRP has adopted Décision n° 0006_AIRP du 26 février 2026 fixing the modalities of batch recall and/or withdrawal, suspension and destruction of substandard and falsified pharmaceutical products (published on the AIRP official document index on 4 March 2026). It is the AIRP's current recall/field-safety-correction instrument: on detection or well-founded suspicion of a substandard, falsified or defective product the AIRP may by reasoned decision order an immediate total or partial recall of one or more batches or of all stocks at every stage of the distribution chain, and the definitive withdrawal of any medical product whose benefit/risk ratio is found unfavourable (art. 3); marketing-authorisation holders, manufacturers, importers and distributors must carry out recalls ordered by the AIRP at their own cost, notify the AIRP without delay and at the latest within twenty-four (24) hours of any suspicion or finding concerning a substandard, falsified or defective medical product, and send the AIRP a documented final recall-closure report (art. 4); falsified or dangerous products may be seized and destroyed under AIRP supervision at the holder's, manufacturer's or importer's cost (art. 5); the AIRP publishes recall/withdrawal/quarantine notices on its website and, where applicable, the WHO GSMS portal (art. 6); breaches expose the author to administrative sanctions without prejudice to criminal proceedings (art. 7).

Conditions
  • The decision's own title adds 'sous standard et falsifiés' to the subject; art. 1 defines the substandard/falsified category (including products 'retiré du marché tel que le rappel de lot').
  • The decision number is garbled in the scan; the number 0006 and the 4 March 2026 index date come from the AIRP document index.

Image-only scan: pdftotext over the retrieved PDF yields a handful of bytes and no readable text. OCR of an official scan is not authorised in this repository, so nothing is quoted; the title and publication date are official metadata from the AIRP document index.

Registration pathways

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

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No device of any class may be placed on the market without a prior AIRP authorisation

registration.prior-authorisation-before-marketing
Fact-level verified

No pharmaceutical product for human use may be placed on the Ivorian market, whether free of charge or for payment, without first obtaining an authorisation from the AIRP. Devices to be homologated go through a national conformity assessment against the essential requirements of safety, quality and performance, sanctioned by an Autorisation de Commercialisation. There is no class-based self-certification or notification-only route in the published procedure.

Conditions
  • The AIRP procedure does not split the homologation route by risk class in its published steps; the class determines the fee band and the classification declaration required in the application letter.
  • Separately from homologation, the introduction of ANY device of any class into Côte d'Ivoire is subject to a prior declaration ('listing') by each supply-chain actor.

French original. Translation: 'No pharmaceutical product for human use may be placed on the market free of charge or for payment in Côte d'Ivoire if it has not first obtained an Authorisation from the Ivorian Pharmaceutical Regulation Authority (AIRP).' Read by OCR of the official scanned AIRP PDF.

Every supply-chain actor must file a prior listing declaration for any device of any class

registration.supply-chain-listing-declaration
Fact-level verified

The introduction into Côte d'Ivoire of any medical device, whatever its class, is subject to a prior declaration by each actor in the supply chain to the AIRP. This declaration, called the listing of medical devices, is made on a declaration form available from the AIRP website. It is a separate obligation from, and additional to, the homologation of the device itself.

Conditions
  • The obligation is on each ACTOR in the supply chain, not on the product alone — manufacturer, importer and distributor each declare.
  • The declaration form is published at www.airp.ci; the procedure document does not set a fee for the listing beyond the fee table's 'Déclaration des dispositifs médicaux' line.

French original. Translation: 'The introduction into Côte d'Ivoire of any Medical Device, whatever its class, is subject to a prior declaration by each of the actors in the supply chain to the Ivorian Pharmaceutical Regulation Authority (AIRP). This declaration, called the listing of Medical Devices, shall be made on the basis of a declaration form (available on the site www.airp.ci).' Read by OCR of the official scanned AIRP PDF.

Reliance & recognition

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

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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.

Côte d'Ivoire 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 Côte d'Ivoire (5 records)

Côte d'IvoireWHO

Prior approval / evidence record

WHO-prequalified IVD collaborative registration route

reliance.who-prequalified-ivd-collaborative-registration
Fact-level verified
Statement

The AIRP participates in the WHO collaborative-registration procedure for WHO-prequalified in-vitro diagnostic medical devices (DMDIV): the applicant files a national registration application with the AIRP, the manufacturer consents to WHO sharing its prequalification assessment dossier, inspection and performance-evaluation results, and the AIRP must take its national decision within 90 calendar days of the regulatory clock. The AIRP may accept or refuse to apply the procedure to any individual application.

Source Approval

WHO prequalification (WHO Prequalification Programme) for in-vitro diagnostic medical devices

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies only to WHO-prequalified in-vitro diagnostic medical devices (DMDIV); the technical data in the national dossier must be essentially the same as the prequalified dossier.
  • A national registration application is still required, and the AIRP decides whether to apply the procedure to each application; the AIRP retains the national decision.
  • The AIRP must report to WHO any deviation from the prequalification conclusion, with reasons.
  • The guideline's scope covers all regulatory functions across the product life cycle (registration and marketing authorisation, vigilance, market surveillance and control, establishment licensing, regulatory inspections, laboratory testing, clinical-trial supervision), and its glossary is drafted for 'des médicaments, des dispositifs médicaux et des diagnostics in vitro'.
  • Domain scoping is load-bearing here. This is an IVD-only route; the device domain in this jurisdiction has no equivalent, per regulatory-fact:cote-divoire:reliance-recognition:reliance-no-device-reliance-route. Do not generalise this fact to medical devices, and do not read that row as covering IVDs.

Effective from 2024-06-24

Source is French; verbatim passage and translation below. The document is AIRP-LD-7.5-03.2-02 version 01, diffusion 31/01/2025, date d'entree en vigueur 24 June 2024, published on the AIRP official document index. ADJUDICATED AGAINST THE ROUND-204 ROW (coordinating session, 2026-09-16): this fact was flagged as contradicting regulatory-fact:cote-divoire:reliance-recognition:reliance-no-device-reliance-route. It does not. That row carries domainIds: ["medical-device"] and its claim is that Cote d'Ivoire operates no abridged, verification or recognition route for MEDICAL DEVICES; this fact carries domainIds: ["ivd"] and reports the route the same authority publishes for WHO-PREQUALIFIED IVDs. The registry scopes reliance negatives by domain, so a device-scoped negative and an IVD-scoped positive are compatible and both stay official-source-verified/source-backed-partial as authored. The two rows must be READ TOGETHER: neither may be rendered on a page without the other's domain restriction, or a customer querying the device row alone will be told Cote d'Ivoire has no reliance route when an IVD route exists. Two related points stand from the same guideline and corroborate the round-204 wording: the Décision n° 03/2022/CM/UEMOA claim is not disturbed because §5.4 of this guideline makes the UEMOA/ECOWAS/OOAS regional decisions non-binding, and the WHO route is a national AIRP procedure rather than a regional one. A different key is used deliberately so the round-204 row is not overwritten by the importer; no status change was made to that row and none should be made without the independent review session checking its cited passage.

Côte d'IvoireEU conformity assessment

Prior approval / evidence record

Certified copy of a conformity attestation from internationally recognised procedures is a mandatory dossier item

reliance.origin-country-conformity-attestation
Fact-level verified
Statement

The device marketing-authorisation dossier must contain a certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP. This is the operative foreign-approval document — a CE certificate or equivalent conformity attestation — and it is a mandatory attachment for every device to be homologated, not a fast-track key. The AIRP does not publish which international procedures it recognises, and the dossier still requires full technical documentation, a risk-management plan and an essential-requirements checklist.

Source Approval

EU CE marking / conformity attestation obtained under the international procedures recognised by the AIRP (the AIRP does not publish the list of recognised procedures)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The source says 'obtenue suite aux procédures internationales reconnues par l'AIRP' — the claim is deliberately not upgraded to 'FDA is accepted', because the source never names FDA, CE or any other scheme.
  • The same dossier section separately requires a copy of any good-manufacturing-practice certificate in force for medical devices, and a valid batch conformity certificate for the device lot.
  • The obligation attaches to the device, not to the applicant: it is filed by the AIRP-agreed Ivorian import/commercialisation company acting for the manufacturer.

French original. Translation: 'A certified copy of the conformity attestation obtained through the international procedures recognised by the AIRP.' The document is a scanned four-page AIRP procedure with no text layer; the passage was read by OCR of the official AIRP PDF at 200 dpi with Tesseract (fra). The identical dossier item appears in the UEMOA harmonised dossier annexes ('une copie certifiée de l'attestation de conformité obtenue suite aux procédures internationales reconnues par l'autorité compétente'), which corroborates the wording.

Côte d'IvoireWHO

Prior approval / evidence record

WHO prequalification

Authority

WHO prequalification

Accepted

No

Benefit

No unilateral reliance route for devices was read in the instruments cited here: the AIRP evaluates the dossier itself, and the UEMOA harmonisation leaves the device marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).

AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — declaration/listing, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list, and the persons authorised to applyDécision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39ARSN — Autorisastion: definition of an authorisation, licence and enregistrement scopes, downloadable forms; Agrément: the service activities subject to agrémentOrdonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI, arts. 88-93 (Journal officiel du 14 août 2012) and the ARTCI homologation procedure page

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

Côte d'IvoireEU 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 the AIRP Autorisation de Commercialisation, but a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP is a required item of the Ivorian dossier, so the CE technical file is reusable evidence.

AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — declaration/listing, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list, and the persons authorised to applyDécision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39ARSN — Autorisastion: definition of an authorisation, licence and enregistrement scopes, downloadable forms; Agrément: the service activities subject to agrémentOrdonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI, arts. 88-93 (Journal officiel du 14 août 2012) and the ARTCI homologation procedure page

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

Côte d'IvoireSource authority not specified

Prior approval / evidence record

Document evidencing first placing on the market in the country of origin is a mandatory dossier item

reliance.first-marketing-origin-country-document
Fact-level verified
Statement

The administrative dossier must include a document attesting the first placing on the market in the country of origin. This is Côte d'Ivoire's functional equivalent of a free-sale certificate requirement: it is separate from the conformity attestation, it is mandatory, and its purpose is to establish that the device is lawfully marketed where it comes from. It confers no shortened review — it is an exhibit in a full national evaluation.

Source Approval

Origin-country document evidencing first placing on the market — the origin-country marketing authorisation, free-sale certificate (certificat de libre vente) or equivalent first-marketing proof; the AIRP does not prescribe the document's form

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The AIRP names no specific document and requires no certification or legalisation of it; the requirement is stated as 'un document attestant la première mise sur le marché dans le pays d'origine'.
  • This is a distinct dossier item from the conformity attestation in item 2, and both are required.
  • The UEMOA harmonised annexes carry the same requirement in shorter form ('un document attestant la première mise sur le marché').

French original. Translation: 'A document attesting the first placing on the market in the country of origin.' Read by OCR of the official scanned AIRP PDF. Note for the customer question: a holder of a CE mark, FDA clearance, PMDA or MFDS approval will normally be able to evidence first marketing in that origin country, so this item is not an additional regulatory hurdle so much as a documentary one — but it is mandatory and it is not a recognition route.

Special access & derogation

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

Compare countries

AIRP emergency-use instrument for non-homologated products

emergency-use.unregistered-products-in-public-health-emergency
Fact-level verified

The AIRP has adopted Décision n° 0005/AIRP/DG du 26 février 2026 fixing the conditions for granting an authorisation to use non-homologated pharmaceutical products in a public-health emergency (published on the AIRP official document index on 4 March 2026). The modalities are set in guidelines annexed to and forming part of the decision (art. 2); the authorisation is valid for twelve months, renewable once (art. 3); it may be modified, suspended or withdrawn, and in case of a public-health risk withdrawal or suspension is pronounced immediately by the Directeur Général (art. 4). It is the national emergency-use instrument sitting alongside the UEMOA requirement that each member state operate an authorisation regime for products used outside routine authorisation.

Conditions
  • The decision's own title reads 'fixant les conditions d'octroi d'une autorisation d'utilisation de produits pharmaceutiques non homologués en situation d'urgence de santé publique'.
  • The annexed guidelines (version 01) carry an approval date of 13 June 2024 and entry into force of 24 June 2024, i.e. they pre-date the decision; eligible products, requesting actor and detailed conditions are in that annex and are not asserted here.

Image-only scan: pdftotext over the retrieved PDF yields a handful of bytes and no readable text. OCR of an official scan is not authorised in this repository, so nothing is quoted; the title and publication date are official metadata from the AIRP document index.

Competent authority must run a donation-management mechanism for devices

special-access.donation-management-mechanism
Fact-level verified

The competent authority must put in place a mechanism for managing donations, comprising the authorisation, control and import of medical devices. Nationally, the AIRP has adopted a decision fixing the conditions for managing and issuing the import authorisation for donations of pharmaceutical products in Côte d'Ivoire (published on its official document index, 18 February 2025): any person wishing to donate pharmaceutical products must first obtain a donation authorisation from the AIRP (art. 1), beneficiaries are approved health establishments (art. 2), donated products must meet the quality standards of the country of provenance and of Côte d'Ivoire and donated medical devices 'doivent absolument être de bonne qualité' (arts. 3–4), the request is addressed to the AIRP Directeur Général with the listed documents including the full list of donated pharmaceutical products and/or biomedical equipment (art. 7), and must be filed before shipment (art. 8).

Conditions
  • The harmonised clause states the mechanism must exist; it does not fix the documentary conditions, which are national.
  • The national donation decision is a scan whose OCR text is readable; the 18 February 2025 date is the AIRP index date and does not appear legibly in the document.
Décision fixant les conditions de gestion et de délivrance de l'autorisation d'importation des dons de produits pharmaceutiques en Côte d'Ivoire

Source is French; verbatim passage and translation below. The supporting source (AIRP donation decision) is an image-only scan retrieved from the AIRP official document index and is cited for identity only.

Standards, testing & ancillary approvals

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

Compare countries

UEMOA definitions: a certificate of conformity is issued by a conformity assessment body recognised by the competent authority; a CAB is a non-regulator body determining compliance with regulations or technical standards

standards.conformity-certificate-and-conformity-assessment-body-definitions
Fact-level verified

Under the UEMOA guidelines applied by AIRP, a 'certificat de conformité' is the written attestation issued by a conformity assessment body recognised by the competent authority stating that the manufacturer correctly applies the essential requirements for medical devices, whereas a 'déclaration de conformité' is the manufacturer's own written attestation that it has applied the conformity-assessment elements matching the device's class. A conformity assessment body (OEC) is a body other than a regulatory authority charged with determining whether the relevant requirements of regulations or technical standards are met.

Conditions
  • The guidelines do not list which conformity assessment bodies are recognised; AIRP's dossier item 2 speaks of 'procédures internationales reconnues par l'AIRP' without naming them.
  • Good practices ('Bonnes pratiques') are defined in the same section as practices based on a set of standards issued by the competent authorities.

Effective from 2022-06-24

English gist as in value. Côte d'Ivoire applies these guidelines through Décision n° 03/2022/CM/UEMOA, already recorded as the legal basis.

The technical dossier must contain an essential-principles conformity checklist that cites the corresponding standards and internal documents, plus a justification of non-applicable requirements

standards.essential-principles-checklist-citing-applied-standards
Fact-level verified

The electronic technical dossier for an Autorisation de Commercialisation must include documentation comprising a checklist demonstrating the device's conformity with the essential requirements of quality, safety and performance together with the corresponding standards and the reference to the internal documents used, and, where necessary, documentation indicating the requirements that do not apply to the device concerned.

Conditions
  • AIRP does not publish a list of recognised standards; the checklist is against the UEMOA essential requirements (Annexes II-1 and II-2 of the UEMOA guidelines) and the applicant names the standards it applied.
  • Also required in the same technical dossier: stability results where applicable, a life-cycle risk-management plan, the technical specifications summary in French and the labelling/IFU models.

English gist: essential-principles checklist naming the standards applied and internal references; non-applicable requirements to be documented. The same wording appears in Annexe IV.1 'Documents techniques' items 3-4 of the UEMOA guidelines.

The device declaration (listing) form requires a copy of a certificate of conformity issued by a recognised authority for class B, C or D devices

standards.listing-form-requires-conformity-certificate-for-class-b-c-d
Fact-level verified

The device declaration form annexed to the UEMOA guidelines, on which the AIRP listing declaration is based, requires that a copy of the certificate of conformity issued by a recognised authority be attached for devices of class B, C or D; class A devices are declared without such a certificate.

Conditions
  • The form's device-identification block also asks for manufacturer, brand/model, trade name, common name and/or intended purpose with GMDN code, and risk class.
  • AIRP states that its own declaration form is available on www.airp.ci; the AIRP site is a JavaScript application and the form itself could not be retrieved on 2026-09-16, so the annexed UEMOA form is cited.

Effective from 2022-06-24

English gist: certificate of conformity from a recognised authority attached to the listing declaration for classes B, C and D.

For quality control of pharmaceutical products AIRP must use the Laboratoire national de la Santé publique and may contract other competent QC laboratories that follow good laboratory practice; QC laboratories need AIRP authorisation

testing.airp-quality-control-through-national-public-health-laboratory
Fact-level verified

Loi n° 2017-541 requires AIRP, for the quality control of pharmaceutical products, to use the Laboratoire national de la Santé publique and all other competent structures of the ministry in charge of health, and allows it, where needed, to contract with any other competent quality-control laboratory that complies with the rules and standards of good laboratory practice in force. The opening and operation of any quality-control laboratory for pharmaceutical products is subject to an authorisation issued by AIRP.

Conditions
  • Medical devices fall within 'produits pharmaceutiques' in the Ivorian regime (already recorded in the registry from the GUCE/AIRP glossary), so Section 10 applies to devices; the Act does not name device-specific test methods.
  • Source is the scanned Journal Officiel; the passage was read by OCR of page 5 (JO p. 1138) and cross-checked against the FAOLEX text layer.

Effective from 2017-08-03

English gist as in value. The first line of Art. 35 is split across the two-column gazette layout in both OCR passes; the excerpt reassembles the sentence in reading order without altering words.

Commissioning (mise en service) of class C and D devices may require a prior technical evaluation, with a conformity certificate attached to the request; the regulator may carry it out at the applicant's expense

testing.pre-commissioning-technical-evaluation-class-c-d
Fact-level verified

The UEMOA guidelines provide that the commissioning of certain high-risk devices, notably those of classes C and D, may require a technical evaluation before the device is put into operation. A document certifying the device's conformity is attached to the applicant's commissioning request to the national regulator, and where necessary the commissioning may be carried out by the regulator at the applicant's expense.

Conditions
  • Framed as a possibility ('il peut être nécessaire'); AIRP has not published a national commissioning procedure or fee.
  • Concerns installed equipment put into service, not IVD reagents.

Effective from 2022-06-24

English gist as in value.

Three final-sale samples in French with at least 12 months' validity and certificates of analysis; a supplementary technical evaluation may be ordered at the applicant's cost

testing.samples-with-certificates-of-analysis-and-supplementary-evaluation
Fact-level verified

The application must include three samples of the definitive sale model presented in French, with at least twelve months of remaining validity, accompanied by certificates of analysis. On the opinion of the expert committee an additional technical evaluation may be required, in which case the evaluation fees are set according to the evaluation protocol required and are borne by the applicant.

Conditions
  • The sample requirement applies to every homologation application whatever the class; the UEMOA guidelines (Annexe IV.1 item 8) allow the competent authority to derogate on the number of samples according to device type.
  • No fee amount for the supplementary technical evaluation is published; it is set case by case by the evaluation protocol.

English gist: three French-labelled final samples with ≥12 months validity and certificates of analysis; supplementary technical evaluation possible on expert-committee advice, fees per protocol at applicant's expense.

Submission communications & appeal

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

Compare countries

The complaint is a written requête in French to the AIRP Director General, filed at AIRP headquarters, with identity, object, grounds, supporting documents and any mandate

submission.appeal-requete-form-language-and-contents
Fact-level verified

The action is introduced by a requête written in French, addressed to the Director General of the AIRP and filed at the Authority's headquarters. It must state the applicant's name, profession, domicile, postal address and telephone contacts (for a legal person: its form, name or company name and the name of its legal representative), the object of the complaint, and a summary of the grounds of fact and law relied on; it must be accompanied by all supporting documents evidencing the dispute and, where lodged through a representative, by the express mandate.

Conditions
  • Filing is in person at AIRP's seat (Cocody-Riviera Bonoumin, Abidjan); the guideline does not provide an electronic filing channel for complaints.

Effective from 2023-10-27

English gist: written petition in French to the AIRP DG, lodged at HQ, with the listed identity, object and grounds elements, supporting documents and an express mandate if filed by a proxy.

Any person with an interest may contest an AIRP act, but must first lodge a recours gracieux (to the AIRP) and then a recours hiérarchique before going to the Conseil d'État

submission.prior-administrative-appeal-required-before-conseil-etat
Fact-level verified

The right to contest an AIRP administrative act is open to any natural or legal person, whether or not an actor of the pharmaceutical sector or a holder of an AIRP authorisation, who shows an interest in acting. Before seising the Conseil d'État with a recours pour excès de pouvoir, the applicant must first make an administrative appeal: first to the author of the act (recours gracieux) asking for its withdrawal or annulment, and, if unsatisfied, to the hierarchical superior of the author (recours hiérarchique).

Conditions
  • Applies to 'actes administratifs délivrés par l'AIRP' generally, which covers device declaration, homologation and establishment decisions; the guideline is not device-specific.
  • The judicial stage (recours pour excès de pouvoir before the Conseil d'État) is already recorded in the registry from the Conseil d'État's own procedure page; this fact adds the mandatory administrative pre-stage.

Effective from 2023-10-27

English gist: standing is open to anyone with an interest; an administrative appeal (gracieux, then hiérarchique) is a precondition to the judicial recours pour excès de pouvoir. The guideline's legal basis section cites Loi organique n° 2020-968 (Conseil d'État), Loi n° 2017-541 and Décret n° 2018-926. The 27 October 2023 date comes from AIRP's file name; the signed date block on page 2 is not machine-readable.

Two-month deadline for the administrative appeal, counted from notification (individual acts) or publication (regulatory or collective acts)

submission.two-month-deadline-for-administrative-appeal
Fact-level verified

The administrative appeal against an AIRP act, whether gracieux or hiérarchique, must be lodged within two months. For individual acts the period runs from notification to the person concerned; for regulatory or collective acts it runs from publication as regards third parties.

Conditions
  • The two-month period for the subsequent judicial recours pour excès de pouvoir is governed separately by the Conseil d'État's organic law (already recorded in the registry).

Effective from 2023-10-27

English gist: two months from notification (individual acts) or publication (regulatory/collective acts).

UDI, listing & traceability

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

Compare countries

AIRP has adopted a national medical-device listing/declaration instrument

listing.national-device-declaration-system-instrument
Fact-level verified

The AIRP has adopted Décision n° 0015/AIRP/DG instituting the system of listing/declaration of medical devices in Côte d'Ivoire (signed at Abidjan on 15 September [2025] by the Directeur Général, Dr Assane Coulibaly; published on the AIRP official document index). Article 2 makes the introduction of any medical device into Côte d'Ivoire subject to a prior declaration by each actor in the supply chain to the AIRP; Article 3 provides that no medical device may be imported, distributed or sold in Côte d'Ivoire, whatever its class, unless it has first been declared to the AIRP, and allows derogations from declaration for certain devices where public-health necessity requires; Article 4 charges the Directeur de l'enregistrement des produits pharmaceutiques and the Directeur de l'Inspection et de la Surveillance du marché with execution, with effect from signature.

Conditions
  • The decision cites Décision n° 03/2022/CM/UEMOA, lois n° 2015-533, 2015-534 and 2017-541, décret n° 2018-926 and the AIRP decisions n° 003/AIRP and 004/AIRP of 26 April 2021 as its legal basis.
  • The decision fixes no form, deadline, fee or sanction; the form and the 10 000 CFA franc fee are in the AIRP homologation procedure.
  • The year of signature is garbled in the scan ('15 SEP.'); the 15 September 2025 index date comes from the AIRP document index, not from the document text.

Image-only scan: pdftotext over the retrieved PDF yields a handful of bytes and no readable text. OCR of an official scan is not authorised in this repository, so nothing is quoted and no article-level claim is made; the title and publication date are official metadata from the AIRP document index.

Traceability duty on manufacturer, importer/exporter and distributor

traceability.identification-system-from-manufacture-to-final-use
Fact-level verified

Failing a traceability system established by the competent authority, the manufacturer must develop and operate an identification system permitting adequate traceability from manufacture to final use of the medical device. Importers/exporters and distributors must apply the traceability system defined by the competent authority or, failing that, the manufacturer's. These duties sit alongside the actor-level 'listing' declaration required before a device is introduced into the country.

Conditions
  • This is a traceability/identification duty, not a unique-device-identifier (UDI) obligation; no UDI rule was found (see the D18 unresolved note).
  • The authority-first ordering means the national traceability system, where established by the AIRP, displaces the manufacturer's own scheme.

Source is French; verbatim passage and translation below.

Vigilance & incident reporting

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

Compare countries

Immediate adverse-event reporting to the authority by all supply-chain actors

vigilance.immediate-adverse-event-reporting-by-supply-chain-actors
Fact-level verified

The manufacturer, the importer/exporter and the distributor must each immediately inform and place at the disposal of the competent authorities (in Côte d'Ivoire, the AIRP) every report of an adverse event concerning a medical device that they receive or hold after investigation, together with the safety corrective measures implemented. The harmonised text fixes no numerical reporting deadline: the duty is expressed as 'immediately'. Reportable event definitions: an 'adverse event' is any unintended medical incident, illness or injury, or any unintended clinical sign, including an abnormal laboratory result, in subjects, users or other persons in the context of a clinical performance study, whether or not linked to the device; a 'serious adverse event' is one causing death; a serious deterioration in the subject's health (life-threatening illness or injury, permanent impairment of the body or bodily functions, hospitalisation or prolongation of hospitalisation, or medical or surgical intervention to prevent such); or foetal distress, foetal death or a congenital abnormality or anomaly.

Conditions
  • The reporting actor is each supply-chain operator holding the report, not the manufacturer alone.
  • No deadline in days is stated in the harmonised instrument; a national order implementing the vigilance systems in Côte d'Ivoire exists on the AIRP document index but is an image-only scan.
  • The channel named in the text is 'les autorités compétentes' (the competent authorities); the AIRP operates a signal-report form on its website, but that page is client-rendered and could not be read as static HTML, so no form identifier is asserted.

Source is French; verbatim passage and translation below.

Related structured datasets

Classification systems · 2 records
Open Ivorian IVD (DMDIV) classes A, B, C and D →
Id

cote-divoire:ivd

Jurisdiction Id

cote-divoire

Domains
  • ivd
Name

Ivorian IVD (DMDIV) classes A, B, C and D

Description

In vitro diagnostic devices are classified on their own four-class table, adopted for the UEMOA member states by UEMOA Décision n° 03/2022/CM/UEMOA, annexe I-2: Classe A (Faible risque individuel et en matière de santé publique), Classe B (Risque individuel modéré et/ou faible risque en matière de santé publique), Classe C (Risque individuel élevé et/ou modéré en matière de santé publique), Classe D (Risque individuel élevé et aussi en matière de santé publique), with the seven DMDIV classification rules. The AIRP prices DMDIV separately in its redevances table, where the fifth column is headed « DMDIV de Classe D (III) » and runs alongside the four medical-device classes headed « Classe A (I) », « Classe B (IIA) », « Classe C (IIB) » and « Classe D (III) », so the Ivorian tariff prices a Class D DMDIV under the EU class III rather than reproducing the DMDIV class table.

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

AIRP

Official Domains
  • airp.ci
  • api.airpdigital.com
  • abmed.bj
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 DMDIV class table with the risk descriptions used here, illustrative examples for each class (clinical-chemistry analysers and culture media in class A; vitamin B12 assay kits, pregnancy self-tests and urine strips in class B; blood-glucose self-tests and HLA typing in class C; HIV and hepatitis tests in class D) and the seven DMDIV rules, including the default class B of Règle 6. The AIRP procedure prices DMDIV but does not reproduce the class descriptions: its single DMDIV tariff column is headed « DMDIV de Classe D (III) ».

Source Title

AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — redevances table (the « DMDIV de Classe D (III) » column) and section II.2.1 point 5 (résumé des caractéristiques techniques en Français)

Source Url

https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open Ivorian classes A, B, C and D (UEMOA/IMDRF axis applied by the AIRP) →
Id

cote-divoire:medical-device

Jurisdiction Id

cote-divoire

Domains
  • medical-device
Name

Ivorian classes A, B, C and D (UEMOA/IMDRF axis applied by the AIRP)

Description

Côte d'Ivoire classifies medical devices on the four-class international axis adopted for the UEMOA member states by UEMOA Décision n° 03/2022/CM/UEMOA, annexe I-1: Classe A (Faible), Classe B (Faible-moyen), Classe C (Moyen-élevé), Classe D (Élevé), with the classification rules in annexe I-1. The AIRP applies it: the Autorisation de Commercialisation request must give "le nom commercial, la présentation, l'usage et la référence du Dispositif Médical, y compris sa classification conformément à celle retenue par la réglementation UEMOA", the dossier must show conformity with the essential requirements, and the AIRP tariff is itself laid out by these four classes plus a column headed « DMDIV de Classe D (III) », its four device columns being headed « Classe A (I) », « Classe B (IIA) », « Classe C (IIB) » and « Classe D (III) ».

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

AIRP

Official Domains
  • airp.ci
  • api.airpdigital.com
  • abmed.bj
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 (classes and classification rules)

    Url

    https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7

    Reviewed On

    2026-09-16

    Supports

    Annexe I-1 fixes the axis the Ivorian procedure adopts: the IMDRF/WHO classification retained in the UEMOA member states, with class A Faible, B Faible-moyen, C Moyen-élevé, D Élevé, followed by the seven families of classification rules. This is where the risk band attached to each class is published; the AIRP procedure itself publishes the four class names only as tariff columns, parenthesising the EU classes beside them (« Classe A (I) », « Classe B (IIA) », « Classe C (IIB) », « Classe D (III) »).

  • Title

    Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle (Direction de l'Activité Pharmaceutique), Politique Pharmaceutique Nationale — Côte d'Ivoire, version 2 of 10 October 2023

    Url

    https://dap.ci/wp-content/uploads/2023/11/PPN-Version-02.10.2023-DAP.pdf

    Reviewed On

    2026-09-16

    Supports

    The authority determination, in the ministry's own words: "L'AIRP est une Autorité Administrative Indépendante dotée de la personnalité juridique et de l'autonomie financière, créée par la loi 2017-541 du 03 août 2017 relative à la régulation du secteur pharmaceutique. L'organisation et le fonctionnement de l'AIRP sont fixés par le décret n° 2018-926 du 12 décembre 2018", and "L'aboutissement de la réforme de la Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) en AIRP a conduit à la création d'une nouvelle direction centrale" — the Direction de l'Activité Pharmaceutique, under arrêté n° 220/MSHP/CAB du 15 octobre 2020. That is the competence move the registry label depends on, so it is cited here rather than asserted.

Source Title

AIRP, « Modalités d'homologation des dispositifs médicaux » (procédure du Directeur Général de l'Autorité Ivoirienne de Régulation Pharmaceutique, prise conformément à la Décision n° 03/2022/CM/UEMOA) — section II (homologation), section II.2.1 point 1 (classification declared by the applicant) and the redevances table

Source Url

https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Côte d'Ivoire registration →
Country

Côte d'Ivoire

Jurisdiction Id

cote-divoire

Country Code

CI

Flag

🇨🇮

Regulator

Autorité Ivoirienne de Régulation Pharmaceutique

Regulator Abbrev

AIRP

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — IMDRF/WHO model adopted for the UEMOA member states by UEMOA Décision n° 03/2022/CM/UEMOA (annexe I-1), with a separate A/B/C/D DMDIV table (annexe I-2)

Classes
  • Id

    arsn-authorisation-or-agrement

    Class Name

    ARSN authorisation, licence, enregistrement or agrément — a device or installation using ionizing radiation

    Pathway

    Autorisation or agrément issued by the ARSN under loi n° 2013-701 du 10 octobre 2013 and décision n° 000010 ARSN/DG du 6 janvier 2026, after a mandatory inspection of the applicant's premises before the grant

    Official Timeline
    Min

    45

    Max

    45

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Décision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39

    Url

    https://website.arsn.ci/wp-content/uploads/2026/01/DECISION-PCR-RELATIVE-AUX-AUTORISATIONS-ET-AGREMENTS-060126.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • Décision n° 000010 ARSN/DG du 6 janvier 2026, art. 18: "L'ARSN dispose d'un délai de quarante-cinq (45) jours calendaires à compter de la complétude du dossier pour accorder ou refuser une autorisation ou un agrément au demandeur." The clock runs from dossier completeness, not from deposit, and an inspection must be carried out before the grant (art. 17).
    • Art. 19 gives the applicant "un délai de vingt et un (21) jours calendaires pour donner suite au courrier de demande de complément de son dossier", failing which a reasoned rejection notice is sent.
    • Art. 6 puts radioactive sources of category 1 to 4 and generators with a tension greater than or equal to 30 kV under a licence; art. 7 puts generators strictly below 30 kV and category 5 sources under enregistrement. The ARSN website still publishes a 40 kV licence threshold on its authorisation page, which the 2026 decision supersedes; the instrument governs.
    • This is not an AIRP device clock and does not replace one: a device that generates or contains a radiation source still needs its AIRP Autorisation de Commercialisation or its listing declaration, and the ARSN authorisation is held by the operator using the device.
    • The published period is route-wide rather than class-specific: it applies to every authorisation and agrément under the decision, whatever the practice, so the row carries the route-wide exemption rather than a risk-class link.
    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 the AIRP Autorisation de Commercialisation, but a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP is a required item of the Ivorian dossier, so the CE technical file is reusable evidence.

  • Authority

    WHO prequalification

    Accepted

    No

    Benefit

    No unilateral reliance route for devices was read in the instruments cited here: the AIRP evaluates the dossier itself, and the UEMOA harmonisation leaves the device marketing authorisation with the national authority (Décision n° 03/2022/CM/UEMOA, art. 2).

Key Requirements
  • Every actor in the device supply chain must file a prior declaration ("listing des Dispositifs Médicaux") with the AIRP before introducing any device into Côte d'Ivoire, whatever its class, and the Autorisation de Commercialisation is granted only on an evaluation of conformity against the UEMOA essential requirements.
  • The Autorisation de Commercialisation application is filed in four copies with the AIRP Director-General by an AIRP-agréé importation/commercialisation company mandated by the manufacturer, and must name the manufacturer, the applicant and the manufacturer's representative.
  • The administrative dossier must include a certified copy of the attestation de conformité obtained through the international procedures recognised by the AIRP, any GMP certificate in force, a document attesting first marketing in the country of origin, a valid batch conformity certificate, the attestation de Prix Grossiste Hors Taxe in CFA francs with the price structure, and proof of payment of the homologation fees.
  • The technical dossier (CD-ROM or DVD-ROM) must carry the stability studies where applicable, a lifecycle risk-management plan, a check-list demonstrating conformity with the essential requirements and the corresponding standards, a summary of the technical specifications in French, and the labelling and instructions-for-use models.
  • Three samples of the final sales model must be supplied in French with at least twelve months of validity, with certificates of analysis; all documents must be in French, in a box or binder naming the product, the laboratory, the representation agency and a telephone contact.
  • The Autorisation de Commercialisation is valid for five years and renewable, and the tariff prices registration, major and minor variations and renewal by class.
  • A supplementary technical evaluation can be required on the expert committee's advice, with the evaluation fees fixed according to the protocol required and charged to the applicant.
  • Any equipment to be connected to a public Telecommunications/ICT network, and any radioelectrical equipment, must be homologated by the ARTCI and hold its certificate before being connected; the test laboratories used must be accredited by the ARTCI, recognised under international agreements or otherwise authorised under Ivorian law.
  • Any activity or practice involving exposure to ionizing radiation requires an ARSN authorisation (licence or enregistrement according to the 30 kV / source-category thresholds) or an ARSN agrément for the listed service activities, granted after an inspection, and the operator must designate a Personne Compétente en Radioprotection.
Local Rep Required

Yes

Local Rep Name

Importateur ou distributeur de dispositifs médicaux agréé par l'AIRP, mandaté par le fabricant (représentant du fabricant)

Mdsap Accepted

No

Mdsap Benefit

No Ivorian reliance instrument accepting MDSAP or ISO 13485 in place of the dossier check-list was read; a GMP certificate in force is a dossier item, and quality-system evidence supports the check-list rather than replacing it.

Registration Validity

5 years for an AIRP Autorisation de Commercialisation (renewable); ARSN enregistrement 5 years, ARSN agrément 2 years and ARSN licences 1 to 3 years according to the practice listed in art. 33 of décision n° 000010; the ARTCI homologation certificate publishes no validity period

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — declaration/listing, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list, and the persons authorised to apply

    Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Effective Date

    2023-05-26

    Accessed Date

    2026-09-16

  • Title

    Décision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 portant conditions de délivrance, de renouvellement, de modification, de suspension, de retrait d'une autorisation, d'un agrément en matière de radioprotection, de sûreté et de sécurité nucléaires — arts. 3-8, 12-14, 16-19, 33-35 and 39

    Url

    https://website.arsn.ci/wp-content/uploads/2026/01/DECISION-PCR-RELATIVE-AUX-AUTORISATIONS-ET-AGREMENTS-060126.pdf

    Accessed Date

    2026-09-16

  • Title

    ARSN — Autorisastion: definition of an authorisation, licence and enregistrement scopes, downloadable forms; Agrément: the service activities subject to agrément

    Url

    https://website.arsn.ci/autorisastion/

    Accessed Date

    2026-09-16

  • Title

    Ordonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI, arts. 88-93 (Journal officiel du 14 août 2012) and the ARTCI homologation procedure page

    Url

    https://www.artci.ci/wp-content/uploads/2024/05/Ordonnance_2012-293.pdf

    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 AIRP. Appoint a Importateur ou distributeur de dispositifs médicaux agréé par l'AIRP, mandaté par le fabricant (représentant du fabricant).

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to AIRP including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    AIRP 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. AIRP may issue questions.

    Duration

    45 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, AIRP issues Côte d'Ivoire market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Côte d'Ivoire fees →
Jurisdiction Id

cote-divoire

Country

Côte d'Ivoire

Country Code

CI

Authority

AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)

Low Risk Local
Min

50000

Max

50000

Currency

XOF

Per Product

Yes

High Risk Local
Min

1000000

Max

2500000

Currency

XOF

Per Product

Yes

Details
  • Id

    declaration-dispositifs-medicaux-dmdiv

    Item

    Prior declaration (listing) of medical devices and DMDIV, any class

    Currency

    XOF

    Amount Local

    10000

    Amount Local Formatted

    XOF 10,000

    Frequency

    Per product

    Notes

    Tariff row « Déclaration des dispositifs médicaux / DMDIV »; the schedule carries XOF 10,000 in every column. Section I makes the declaration compulsory for every supply-chain actor whatever the device class.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    enregistrement-classe-a

    Item

    Marketing authorisation (Autorisation de Commercialisation) — Class A device, registration (redevance de base)

    Currency

    XOF

    Amount Local

    50000

    Amount Local Formatted

    XOF 50,000

    Frequency

    Per product

    Notes

    Tariff row « Enregistrement (Redevance de base) », Classe A (I) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    enregistrement-classe-b

    Item

    Marketing authorisation — Class B device, registration (redevance de base)

    Currency

    XOF

    Amount Local

    250000

    Amount Local Formatted

    XOF 250,000

    Frequency

    Per product

    Notes

    Tariff row « Enregistrement (Redevance de base) », Classe B (IIA) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    enregistrement-classe-c

    Item

    Marketing authorisation — Class C device, registration (redevance de base)

    Currency

    XOF

    Amount Local

    500000

    Amount Local Formatted

    XOF 500,000

    Frequency

    Per product

    Notes

    Tariff row « Enregistrement (Redevance de base) », Classe C (IIB) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    enregistrement-classe-d

    Item

    Marketing authorisation — Class D device, registration (redevance de base)

    Currency

    XOF

    Amount Local

    1000000

    Amount Local Formatted

    XOF 1,000,000

    Frequency

    Per product

    Notes

    Tariff row « Enregistrement (Redevance de base) », Classe D (III) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    enregistrement-dmdiv

    Item

    Marketing authorisation — DMDIV, registration (redevance de base)

    Currency

    XOF

    Amount Local

    2500000

    Amount Local Formatted

    XOF 2,500,000

    Frequency

    Per product

    Notes

    The fifth and highest tariff column, headed « DMDIV de Classe D (III) », carries XOF 2,500,000 for registration, the same as the four medical-device columns for a major variation.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-majeure-classe-a

    Item

    Marketing authorisation — Class A device, major variation

    Currency

    XOF

    Amount Local

    50000

    Amount Local Formatted

    XOF 50,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation majeure », Classe A (I) column — same amount as Class A registration.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-majeure-classe-b

    Item

    Marketing authorisation — Class B device, major variation

    Currency

    XOF

    Amount Local

    250000

    Amount Local Formatted

    XOF 250,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation majeure », Classe B (IIA) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-majeure-classe-c

    Item

    Marketing authorisation — Class C device, major variation

    Currency

    XOF

    Amount Local

    500000

    Amount Local Formatted

    XOF 500,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation majeure », Classe C (IIB) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-majeure-classe-d

    Item

    Marketing authorisation — Class D device, major variation

    Currency

    XOF

    Amount Local

    1000000

    Amount Local Formatted

    XOF 1,000,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation majeure », Classe D (III) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-majeure-dmdiv

    Item

    Marketing authorisation — DMDIV, major variation

    Currency

    XOF

    Amount Local

    2500000

    Amount Local Formatted

    XOF 2,500,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation majeure », « DMDIV de Classe D (III) » column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-mineure-classe-a

    Item

    Marketing authorisation — Class A device, minor variation

    Currency

    XOF

    Amount Local

    10000

    Amount Local Formatted

    XOF 10,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation mineure », Classe A (I) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-mineure-classe-b

    Item

    Marketing authorisation — Class B device, minor variation

    Currency

    XOF

    Amount Local

    25000

    Amount Local Formatted

    XOF 25,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation mineure », Classe B (IIA) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-mineure-classe-c

    Item

    Marketing authorisation — Class C device, minor variation

    Currency

    XOF

    Amount Local

    50000

    Amount Local Formatted

    XOF 50,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation mineure », Classe C (IIB) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-mineure-classe-d

    Item

    Marketing authorisation — Class D device, minor variation

    Currency

    XOF

    Amount Local

    100000

    Amount Local Formatted

    XOF 100,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation mineure », Classe D (III) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    variation-mineure-dmdiv

    Item

    Marketing authorisation — DMDIV, minor variation

    Currency

    XOF

    Amount Local

    250000

    Amount Local Formatted

    XOF 250,000

    Frequency

    Per variation

    Notes

    Tariff row « Variation mineure », « DMDIV de Classe D (III) » column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    renouvellement-classe-a

    Item

    Marketing authorisation — Class A device, renewal (renouvellement)

    Currency

    XOF

    Amount Local

    25000

    Amount Local Formatted

    XOF 25,000

    Frequency

    Per product, every 5 years

    Notes

    Tariff row « Renouvellement », Classe A (I) column; the Autorisation de Commercialisation is "valable pour une période de cinq (5) ans renouvelables".

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    renouvellement-classe-b

    Item

    Marketing authorisation — Class B device, renewal (renouvellement)

    Currency

    XOF

    Amount Local

    125000

    Amount Local Formatted

    XOF 125,000

    Frequency

    Per product, every 5 years

    Notes

    Tariff row « Renouvellement », Classe B (IIA) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    renouvellement-classe-c

    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

    Tariff row « Renouvellement », Classe C (IIB) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    renouvellement-classe-d

    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

    Tariff row « Renouvellement », Classe D (III) column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    renouvellement-dmdiv

    Item

    Marketing authorisation — DMDIV, renewal (renouvellement)

    Currency

    XOF

    Amount Local

    1250000

    Amount Local Formatted

    XOF 1,250,000

    Frequency

    Per product, every 5 years

    Notes

    Tariff row « Renouvellement », « DMDIV de Classe D (III) » column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

  • Id

    declaration-reactifs-biologie-medicale

    Item

    Declaration of medical-biology laboratory reagents

    Currency

    XOF

    Amount Local

    10000

    Amount Local Formatted

    XOF 10,000

    Frequency

    Per product

    Notes

    Tariff row « Déclaration des réactifs de laboratoire de biologie médicale », a single amount spanning the schedule rather than a per-class column.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Source Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Source Effective Date

    2023-05-26

    Verified On

    2026-09-16

Notes
  • Amounts are in CFA francs (XOF), which has no subunit; the schedule publishes whole francs, and the dossier requires the attestation de Prix Grossiste Hors Taxe "en francs CFA".
  • The source's effectiveDate is the date the procedure carries on its cover, "Abidjan, le 26.05.2023" (document N° 0970/AIRP); the schedule states no separate entry-into-force clause, so no later date is asserted.
  • "Le montant de la redevance de base est réduit de moitié pour les Dispositifs Médicaux fabriqués dans l'espace UEMOA" — the halving applies to the registration base fee, so a device manufactured inside the UEMOA area pays half the Classe A-D and DMDIV registration amounts above.
  • The schedule's five columns are headed « Classe A (I) », « Classe B (IIA) », « Classe C (IIB) », « Classe D (III) » and « DMDIV de Classe D (III) »: the AIRP's own tariff therefore maps the Ivorian device classes A to D onto the EU classes I, IIA, IIB and III, and prices a single DMDIV column, for the Class D DMDIV. The procedure prices no other DMDIV class, and whether a Class A, B or C DMDIV is charged the Class D column is not stated.
  • lowRiskLocal is the Class A enregistrement amount (XOF 50,000) and highRiskLocal spans the Class D enregistrement amount (XOF 1,000,000) to the « DMDIV de Classe D (III) » column (XOF 2,500,000); the declaration fee of XOF 10,000 sits below both and is stated as its own row.
  • Payment is "par un chèque bancaire barré à l'ordre de : « AUTORITÉ IVOIRIENNE DE REGULATION PHARMACEUTIQUE »", and the file requires "l'original du chèque plus trois (3) copies".
  • A second, unquantified cost sits behind the fixed tariff: "Sur avis du comité d'expert, une évaluation technique supplémentaire peut être requise. Dans ce cas, les frais d'évaluation seront fixés en fonction du protocole d'évaluation requis. Ces frais d'évaluation seront à la charge du demandeur" — a quote-required amount with no published figure.
  • Two other Ivorian device-related charges exist in law without a published amount in the instruments read: the ARTCI homologation droit of art. 88 of ordonnance n° 2012-293, left to an arrêté conjoint of the ministers of Economy/Finance and Telecommunications/TIC, and the ARSN dossier-study, renewal and modification fees of arts. 16, 21, 38 and 41 of décision n° 000010 ARSN/DG du 6 janvier 2026, which refer to "la réglementation en vigueur" without amounts.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    AIRP, « Modalités d'homologation des dispositifs médicaux », N° 0970/AIRP, dated « Abidjan, le 26.05.2023 » — « REDEVANCES » table, section II.2.4 et tableau des redevances, pp. 3-4 (Classe A (I), Classe B (IIA), Classe C (IIB), Classe D (III) and the DMDIV de Classe D (III) column)

    Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

    Effective Date

    2023-05-26

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Côte d'Ivoire certifications →
Slug

cote-divoire

Market

Côte d'Ivoire

Confidence

high

Schemes
  • Id

    airp-emc-essential-requirements

    Name

    AIRP conformity assessment — electromagnetic compatibility

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Electrical Electronic Medical Device

    Note

    The AIRP's homologation is "assujettie à une évaluation de conformité vis-à-vis des exigences essentielles en matière de sécurité, de qualité et de performance", and the technical dossier must contain "une documentation comportant une check-list démontrant la conformité du dispositif médical aux exigences essentielles de qualité, de sécurité et de performance précitées ainsi que les normes correspondantes". Those essential requirements are the UEMOA ones: annexe II-1, sections B9.5 and B9.6, require a device to be designed and manufactured so as to reduce as far as possible the risk of creating electromagnetic interference in the usual environment and to ensure an adequate level of intrinsic immunity to electromagnetic disturbance (B8.2 and B8.3 for DMDIV). Côte d'Ivoire issues no separate EMC certificate, so the requirement is evidence inside the Autorisation de Commercialisation dossier.

    Source Urls
    • https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf
    • https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7
    Source Binding

    reviewed

  • Id

    airp-electrical-safety-essential-requirements

    Name

    AIRP conformity assessment — protection against electrical hazards

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Electrical Electronic Medical Device

    Note

    Same route: the conformity check-list filed with the AIRP must demonstrate conformity with the essential requirements of quality, safety and performance. UEMOA annexe II-1, 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 in normal use and in the event of a single fault (B8.4 for DMDIV), and B9.1 to B9.4 carry the active-device alarm duties. No Ivorian electrical-safety certificate exists as a separate instrument.

    Source Urls
    • https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf
    • https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7
    Source Binding

    reviewed

  • Id

    artci-radio-equipment-homologation

    Name

    ARTCI homologation of radioelectrical equipment

    Category

    Radio Spectrum

    Status

    Mandatory Pre Market

    Object

    Radio Equipment

    Note

    Ordonnance n° 2012-293 du 21 mars 2012, art. 88: "Les équipements destinés à être connectés à un réseau de Télécommunications/TIC ouvert au public et les équipements radioélectriques doivent faire l'objet d'une évaluation de leur conformité aux exigences essentielles par l'ARTCI. Les équipements qui satisfont aux exigences sont homologués par l'ARTCI. L'homologation est matérialisée par un certificat établi par l'ARTCI." The ARTCI operates the route: it publishes the "Demande d'homologation d'équipement terminal et/ou radioélectrique" form and the lists of equipment it has homologated. A device with a radio module therefore needs an ARTCI homologation certificate before being connected, separately from its AIRP registration.

    Source Urls
    • https://www.artci.ci/wp-content/uploads/2024/05/Ordonnance_2012-293.pdf
    • https://artci.ci/homologations/
    • https://www.artci.ci/demande_homologation_equipement/
    Source Binding

    reviewed

  • Id

    artci-terminal-equipment-homologation

    Name

    ARTCI homologation of terminal equipment connected to a public network

    Category

    Telecom Network Attachment

    Status

    Mandatory Pre Market

    Object

    Covered Terminal Equipment

    Note

    The first limb of art. 88 of ordonnance n° 2012-293 covers equipment intended to be connected to a public Telecommunications/ICT network, not only radioelectrical equipment, and homologation is materialised by an ARTCI certificate. Art. 92 adds that the test laboratories used to establish conformity must be accredited by the ARTCI, recognised in Côte d'Ivoire under international agreements, or otherwise authorised under Ivorian law. Wired terminal equipment with no radio element therefore still needs the ARTCI homologation, and the same application form covers terminal and radioelectrical equipment.

    Source Urls
    • https://www.artci.ci/wp-content/uploads/2024/05/Ordonnance_2012-293.pdf
    • https://artci.ci/homologations/
    • https://www.artci.ci/demande_homologation_equipement/
    Source Binding

    reviewed

  • Id

    arsn-ionizing-radiation-authorisation-or-agrement

    Name

    ARSN authorisation, licence, enregistrement or agrément for ionizing-radiation activities

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Generator Source Or Product Practice

    Note

    Décision n° 000010 ARSN/DG du 6 janvier 2026, art. 4 requires any legal person intending an activity or practice involving exposure to ionizing radiation to obtain an authorisation or an agrément from the ARSN beforehand; art. 6 puts radioactive sources of category 1 to 4 and generators whose tension (kV) is greater than or equal to 30 under a licence, and art. 7 puts generators strictly below 30 kV and category 5 sources under enregistrement. The ARSN's own pages list the agrément activities (including "Installation des appareils de radiologie émetteur de rayonnements ionisants") and define an authorisation as permission to carry out a practice under loi n° 2013-701 du 10 octobre 2013. A device that generates or contains a radiation source therefore needs an ARSN authorisation held by the operator in addition to its AIRP registration.

    Source Urls
    • https://website.arsn.ci/wp-content/uploads/2026/01/DECISION-PCR-RELATIVE-AUX-AUTORISATIONS-ET-AGREMENTS-060126.pdf
    • https://website.arsn.ci/autorisastion/
    • https://website.arsn.ci/agrement/
    Source Binding

    reviewed

  • Id

    airp-supply-chain-listing-declaration

    Name

    AIRP prior declaration (listing) by every actor in the device supply chain

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Imported Shipment

    Note

    AIRP, modalités d'homologation, section I: "L'introduction en Côte d'Ivoire de tout Dispositif Médical, quelle que soit sa classe est subordonnée à une déclaration préalable de chacun des acteurs de la chaine d'approvisionnement auprès de l'Autorité Ivoirienne de Régulation Pharmaceutique (AIRP). Cette déclaration, appelée listing des Dispositifs Médicaux se fera sur la base d'un formulaire de déclaration". The declaration applies whatever the class, so it bites even on class A devices that are otherwise lightly handled, and the AIRP prices it separately in the redevances table at XOF 10,000.

    Source Urls
    • https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf
    Source Binding

    reviewed

Official Sources
  • Authority

    AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)

    Topic

    Modalités d'homologation des dispositifs médicaux — declaration/listing of every supply-chain actor, the Autorisation de Commercialisation dossier and its five-year validity, the conformity check-list against the essential requirements, and the redevances table

    Url

    https://api.airpdigital.com/storage/prestations/modalites%20d'homologation%20des%20dispositifs%20medicaux.pdf

  • Authority

    AIRP (Autorité Ivoirienne de Régulation Pharmaceutique)

    Topic

    UEMOA Décision n° 03/2022/CM/UEMOA portant adoption des lignes directrices relatives à l'harmonisation de la réglementation des dispositifs médicaux — published in the AIRP's own document library

    Url

    https://api.airpdigital.com/storage/documents/decision%20n%C2%B003%20reglementation%20dispositifs%20medicaux%20(3).pdf

  • Authority

    UEMOA — Commission de l'Union économique et monétaire ouest-africaine (texte intégral des lignes directrices et de leurs annexes, hébergé par l'Agence béninoise du médicament)

    Topic

    Décision n° 03/2022/CM/UEMOA and annexes I-1 (device classes and rules), I-2 (DMDIV classes and rules), II-1 (essential requirements for devices) and II-2 (essential requirements for DMDIV)

    Url

    https://abmed.bj/lirePDF/c12210d1-d2cc-4300-965c-746d796165e7

  • Authority

    ARTCI (Autorité de Régulation des Télécommunications/TIC de Côte d'Ivoire)

    Topic

    Ordonnance n° 2012-293 du 21 mars 2012 relative aux Télécommunications et aux Technologies de l'Information et de la Communication, titre VI « Homologation des équipements et agrément d'installateurs », arts. 88-93, Journal officiel du 14 août 2012, p. 154

    Url

    https://www.artci.ci/wp-content/uploads/2024/05/Ordonnance_2012-293.pdf

  • Authority

    ARTCI

    Topic

    Homologations — demande d'homologation d'équipement terminal et/ou radioélectrique and the lists of equipment homologated by the ARTCI

    Url

    https://artci.ci/homologations/

  • Authority

    ARTCI

    Topic

    Formulaire de demande d'homologation d'équipement terminal et/ou radioélectrique — application form, technical characteristics annex

    Url

    https://www.artci.ci/demande_homologation_equipement/

  • Authority

    ARSN (Autorité de Radioprotection, de Sûreté et de Sécurité Nucléaires)

    Topic

    Décision n° 000010 ARSN/DG du 6 janvier 2026 modifiant la décision n° 000005 ARSN/DG du 3 mai 2021 — conditions de délivrance, de renouvellement, de modification, de suspension et de retrait d'une autorisation ou d'un agrément (arts. 3-8 thresholds, 12-14 dossier contents, 16-19 the 45-day and 21-day periods, 33-35 validity, 39 renewal window)

    Url

    https://website.arsn.ci/wp-content/uploads/2026/01/DECISION-PCR-RELATIVE-AUX-AUTORISATIONS-ET-AGREMENTS-060126.pdf

  • Authority

    ARSN

    Topic

    Autorisastion — the ARSN's definition of an authorisation, the licence and enregistrement scopes, and the downloadable forms

    Url

    https://website.arsn.ci/autorisastion/

  • Authority

    ARSN

    Topic

    Agrément — the service activities subject to ARSN agrément, including installation of ionizing-radiation radiology equipment

    Url

    https://website.arsn.ci/agrement/

  • Authority

    Ministère de la Santé, de l'Hygiène Publique et de la Couverture Maladie Universelle — Direction de l'Activité Pharmaceutique

    Topic

    Politique Pharmaceutique Nationale — Côte d'Ivoire (version 2, 10 October 2023): the AIRP's creating law (loi n° 2017-541 du 3 août 2017) and organising decree (décret n° 2018-926 du 12 décembre 2018), and the DPML-to-AIRP reform

    Url

    https://dap.ci/wp-content/uploads/2023/11/PPN-Version-02.10.2023-DAP.pdf

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DJ Fang
Need to apply Côte d'Ivoire's requirements to a product?
Confirm the current AIRP pathway, evidence, and local-role details for the actual device before filing.
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