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Côte d'Ivoire medical device registration resources

Research AIRP registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Côte d'Ivoire medical device resource.

4 free resources24/25 topics with recordsSep 2026 fees reviewed
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AI medical device classifier

Describe your device and get a preliminary AIRP risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Côte d'Ivoire requirements.

Government registration fees

Review current AIRP application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Structured regulatory requirements

Explore all 38 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
AIRP is the competent authority for medical devices, as the UEMOA-designated pharmaceutical regulatory authority
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'…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
UEMOA Décision n° 03/2022/CM/UEMOA of 24 June 2022 is the regional legal basis for the device regime
Côte d'Ivoire's medical device regulation derives from UEMOA Décision n° 03/2022/CM/UEMOA of 24 June 2022, which adopted the guidelines harmonising medical device regulation across the Unio…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Verified
Harmonised UEMOA definition of medical device, IVD and software scope
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,…
1 source-linked fact
Checked 2026-09-16
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D04

Classification rules

Verified
Ivorian classes A, B, C and D (UEMOA/IMDRF axis applied by the AIRP)
Classe A — Faible, Classe B — Faible-moyen, Classe C — Moyen-élevé, Classe D — Élevé
1 maintained scheme · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
No device of any class may be placed on the market without a prior AIRP authorisation
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 hom…
Every supply-chain actor must file a prior listing declaration for any device of any class
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…
2 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Document evidencing first placing on the market in the country of origin is a mandatory dossier item
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 sal…
Certified copy of a conformity attestation from internationally recognised procedures is a mandatory dossier item
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…
3 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Only manufacturers, or AIRP-agreed Ivorian import/commercialisation companies mandated by the manufacturer, may apply
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 agree…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Authorisation required to manufacture, import, export, distribute or sell devices
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 manufactu…
1 source-linked fact
Checked 2026-09-16
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D09

Dossier requirements

Verified
Seven administrative items in hard copy plus a technical file on CD/DVD-ROM
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 t…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
The listing declaration form is published on the AIRP website; applications address the Directeur Général
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 th…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Every document in the application must be in French, including the technical summary and the labelling and IFU models
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 r…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Inspection carried out by sworn AIRP pharmacy inspectors with seizure powers
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, recordi…
Manufacturer must comply with device GMP and keep the conformity documentation
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 assessme…
2 source-linked facts
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
AIRP conformity assessment — electromagnetic compatibility
EMC
AIRP conformity assessment — protection against electrical hazards
Electrical safety
ARTCI homologation of radioelectrical equipment
Wireless / radio
6 maintained overlays · 6 related facts
Checked 2026-09-16
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D14

Fees

Verified
Prior declaration (listing) of medical devices and DMDIV, any class
XOF 10,000
Marketing authorisation (Autorisation de Commercialisation) — Class A device, registration (redevance de base)
XOF 50,000
22 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Verified
ARSN authorisation, licence, enregistrement or agrément — a device or installation using ionizing radiation · 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
45 days
1 maintained pathway
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Autorisation de Commercialisation valid five years, renewable; renewal fee is half the base fee
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 carri…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Post-authorisation changes are handled as major or minor variations on a published fee schedule
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 majo…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
AIRP has adopted a national medical-device listing/declaration instrument
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 Gé…
Traceability duty on manufacturer, importer/exporter and distributor
Failing a traceability system established by the competent authority, the manufacturer must develop and operate an identification system permitting adequate traceability from manufacture to…
2 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical evaluation may rest on literature review and clinical experience
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. Th…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
AIRP emergency-use instrument for non-homologated products
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 emerge…
Competent authority must run a donation-management mechanism for devices
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 decisio…
2 source-linked facts
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Life-cycle vigilance system and manufacturer post-market risk-reduction duties
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…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Immediate adverse-event reporting to the authority by all supply-chain actors
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…
1 source-linked fact
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Mandatory market-surveillance system components and safe-disposal mechanism
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…
AIRP instrument fixing batch recall, withdrawal, suspension and destruction
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…
2 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
AIRP is charged with regulating promotion and publicity for medical devices
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…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
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
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, profess…
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
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…
3 source-linked facts
Checked 2026-09-16
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Government fees

Full fee schedule (22 lines) →

AIRP (Autorité Ivoirienne de Régulation Pharmaceutique) registration fees in XOF · reviewed 2026-09-16

Fee lineAmountProvenance
Prior declaration (listing) of medical devices and DMDIV, any classXOF 10,000Verified
Marketing authorisation (Autorisation de Commercialisation) — Class A device, registration (redevance de base)XOF 50,000Verified
Marketing authorisation — Class B device, registration (redevance de base)XOF 250,000Verified
Marketing authorisation — Class C device, registration (redevance de base)XOF 500,000Verified
18 more fee lines on the full schedule · 22 of 22 rows source-verified

Registration timeline

Full registration timeline →

Autorité Ivoirienne de Régulation Pharmaceutique (AIRP) review clocks and planning ranges · 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) classification

Class / pathwayReview clockPlanning totalProvenance
ARSN authorisation, licence, enregistrement or agrément — a device or installation using ionizing radiation(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)45 days2-4 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(45 days)
  5. 5Registration Approval(1-2 weeks)
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Côte d'Ivoire change notification workpaper

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Côte d'Ivoire regulatory change impact

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