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Agence Nationale du Médicament et des Produits de Santé (ANMPS) · structured requirements

🇹🇳 Tunisia IVD regulatory data

Explore the IVD requirements currently available for Tunisia, organized by topic and linked to official sources.

1 facts1 dimensions1 official sourceslatest verification 2026-09-16

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Tunisia. Each question separates published rules from details still awaiting verification.

Classification rules

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

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Tunisia uses the EU MDR risk-class taxonomy I, Is, Im, IIa, IIb, III — no separate national scheme

classification.eu-mdr-risk-class-taxonomy
Fact-level verified

Tunisia applies the European MDR risk-class taxonomy rather than a national classification scheme: the manufacturer's declaration of conformity in the Tunisian device dossier must state the device's risk class as I, Is, Im, IIa, IIb or III, and the dossier guide's sole normative reference is Regulation (EU) 2017/745. The conformity evidence the guide requires is likewise the EU certificate issued under that regulation according to the device's risk class.

Conditions
  • The Is (sterile) and Im (measuring) sub-classes are MDR-specific, which confirms the taxonomy is adopted rather than parallel.
  • No Tunisian classification rules, classification guidance or classification decision tree separate from the EU regime was located.
  • Because classification is expressed through the manufacturer's own declaration of conformity, the class is asserted by the manufacturer and checked by ANMPS during the avis technique or analyse.

Effective from 2026-03-02

French original. §1.4 Références reads in full: '- Règlement de l'Union Européenne (UE) 2017/745'. The class line reads: '- Classe de risque du dispositif (I,Is,Im, IIa, IIb, III).' And §2.1 point f.1 requires 'Un certificat de conformité CE selon la classe de risque du DM et les exigences du règlement 2017/745.' The two quoted lines are given in order of appearance in the document, joined here. Retrieved as full raw text of the ANMPS PDF.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Tunisia registration →
Country

Tunisia

Jurisdiction Id

tunisia

Country Code

TN

Flag

🇹🇳

Regulator

Agence Nationale du Médicament et des Produits de Santé

Regulator Abbrev

Agence Nationale du Médicament et des Produits de Santé (ANMPS)

Region

africa

Tier

3

Risk Classification

EU MDR classes I, Is, Im, IIa, IIb and III, applied by reference in the ANMPS technical dossier

Classes
  • Id

    cert-sample-withdrawal-authorisation

    Class Name

    CERT authorisation to withdraw a representative sample for homologation

    Pathway

    Application to the CERT guichet unique with the form, invoice, arrival notice, technical documentation, certificate of origin and, where necessary, trade-register and tax identifiers

    Official Timeline
    Min

    2

    Max

    2

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    CERT — procédure d'obtention du certificat d'homologation: 48 hours for the sample-withdrawal authorisation, then 3, 7 or 21 working days depending on the route, from receipt of a complete dossier

    Url

    https://www.cert.tn/fr/pdf/32.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Unit

    weeks

    Notes
    • The CERT procedure states forty-eight (48) hours from delivery of a complete dossier; it is recorded as 2 days because the registry's unit vocabulary is days, weeks and months.
    • This step only releases a representative unit of the equipment; it is not the homologation decision and does not by itself permit commercialisation.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    cert-homologation-certificate

    Class Name

    CERT homologation certificate — radio and telecommunications terminal equipment

    Pathway

    Homologation by the CERT services on an application filed with the guichet unique (décret gouvernemental n° 2020-48 du 23 janvier 2020)

    Official Timeline
    Min

    3

    Max

    21

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    CERT — procédure d'obtention du certificat d'homologation: 48 hours for the sample-withdrawal authorisation, then 3, 7 or 21 working days depending on the route, from receipt of a complete dossier

    Url

    https://www.cert.tn/fr/pdf/32.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • The CERT procedure publishes three tiers, all counted in jours ouvrables from receipt of a complete dossier or, where applicable, from filing of the requested supplement: 3 working days for files handled at the guichet unique, 7 working days for files transferred to the centre's laboratories, and 21 working days where the Agence Nationale des Fréquences must give an opinion. The range published here spans the three tiers, in working days.
    • A file in dispute has a maximum processing period of three months.
    • The CERT also publishes a tariff of EUR 930 for applicants resident abroad, excluding customs clearance costs; it is expressed in euro and is a radio-homologation charge, so it is not published in the Tunisian fee dataset.
    • Applies to a medical device only where it contains radio or telecommunications terminal equipment.
    Clinical Trial Required

    No

    Local Testing Required

    Yes

    Gmp Required

    No

Prior Approvals
  • Authority

    EU CE certificate of conformity (Regulation (EU) 2017/745, NANDO-listed notified body)

    Accepted

    No

    Benefit

    Mandatory dossier evidence for every class except class I, and the regime the ANMPS guide names as the benchmark; where no valid MDR certificate exists the agency accepts an Annex VII §4.3 written agreement with a notified body or a notified-body letter under Regulation (EU) 2023/607. It does not replace the Tunisian AMC, which the ANMPS issues after its own avis technique or analyse.

  • Authority

    US FDA 510(k) / PMA

    Accepted

    No

    Benefit

    Named in the ANMPS dossier guide as the conformity evidence for devices declaring conformity to United States legislation — a copy of the 510(k) for class I and class II, and a copy of the PMA for class III. Dossier evidence only, with no shortened review.

  • Authority

    Health Canada medical device licence

    Accepted

    No

    Benefit

    Named in the ANMPS dossier guide as the conformity evidence for devices declaring conformity to Canadian legislation. Dossier evidence only.

  • Authority

    Japan PMDA / Korea MFDS / other non-listed approvals

    Accepted

    No

    Benefit

    Not named anywhere in the ANMPS device dossier guide: a product holding only a PMDA or MFDS approval has no listed documentary route and must rely on the agency's reservation clause permitting it to request other documents.

Key Requirements
  • The applicant is the Tunisian importer, not the foreign manufacturer: the AMC is granted to a named importer for a named foreign supplier, and the importer signs an 'Engagement pour CTI' form (F-OP2-001-FR) for every importation.
  • The technical dossier for the avis technique track comprises the fiche de liaison, the Autorisation Provisoire d'Enlèvement, the detailed purchase invoice, a valid or less-than-five-year-old free-sale certificate from the competent authority of the country of origin, the manufacturer's declaration of conformity with the risk class and the Basic UDI-DI, the conformity certificate keyed to the regime claimed (CE certificate under Regulation (EU) 2017/745 from a NANDO-listed notified body, or ISO 13485 for class I, or US 510(k)/PMA, or a Health Canada licence), product-type-specific evidence (per-lot physico-chemical and microbiological analysis, sterility attestation, ISO 10993 biocompatibility attestations, ISO 22442 or Regulation (EU) 722/2012 for animal-derived devices) and a labelling mock-up.
  • The analyse track adds a signed per-lot analysis bulletin stating the tests, the acceptability intervals and the normative reference of each test, plus a detailed description of the analysis methods; where the finished-product specifications at shelf life differ from those at release, both must be supplied.
  • The manufacturer's declaration of conformity must state the legislation complied with (the guide gives Regulation (EU) 2017/745 as the example) and the notified-body identification where applicable, and where devices are identified by Basic UDI-DI their correspondence must be visible.
  • A valid or less-than-five-year-old free-sale certificate from the competent authority of the country of origin must be maintained, because it has to accompany repeat importations.
  • A change to composition, manufacturing process, conformity certificate or labelling disqualifies the product from the light administrative AMC track and returns it to control by the ANMPS technical services at the next importation until the dossier has been re-assessed.
  • A serious vigilance incident internationally is a bar to the light administrative track, so an incident reported to a foreign regulator can affect Tunisian import clearance even where nothing occurred locally.
  • Importation of a device that customs has reclassified into chapter 30 of the customs tariff is subject to the State import monopoly and requires a prior twelve-month derogation from the health authority.
  • The ANMPS reserves the right to require further documents beyond the published dossier list, and to send a product for technical control whenever it judges it necessary.
Local Rep Required

Yes

Local Rep Name

Importateur tunisien — the AMC applicant and the signatory of the per-importation 'Engagement pour CTI'; no separate local-agent or authorised-representative regime for devices was located

Mdsap Accepted

No

Mdsap Benefit

No MDSAP route: the ANMPS dossier requires an ISO 13485 certificate for class I and a CE certificate under Regulation (EU) 2017/745 from a NANDO-listed notified body for the other classes, and an MDSAP audit report is not named as accepted evidence.

Registration Validity

No stated validity: the AMC is tied to an importation, and the procedure operates a rolling two-year evidentiary window for the light administrative track rather than a certificate term

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    CERT — procédure d'obtention du certificat d'homologation: 48 hours for the sample-withdrawal authorisation, then 3, 7 or 21 working days depending on the route, from receipt of a complete dossier

    Url

    https://www.cert.tn/fr/pdf/32.pdf

    Accessed Date

    2026-09-16

  • Title

    ANMPS — procédure de contrôle des dispositifs médicaux au CTI (P-OP2-001-FR), §2.1 à §2.4: AMC tracks, per-importation undertaking, disqualifying changes and the two-year evidentiary window

    Url

    https://portail.anmps.tn/sites/default/files/2025-09/p-op2-001-fr-000-controle-dm-ca-cos-objets-de-puericulture-cti.pdf

    Accessed Date

    2026-09-16

  • Title

    ANMPS — guide d'élaboration d'un dossier technique de dispositifs médicaux (T-OP9-003-FR), §2.1 et §2.2: dossier items and the analyse add-ons

    Url

    https://portail.anmps.tn/sites/default/files/2026-03/T-OP9-003-FR-000-GUIDE%20D%E2%80%99ELABORATION%20D%E2%80%99UN%20DOSSIER%20TECHNIQUE%20DE%20DISPOSITIFS%20MEDICAUX.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 Agence Nationale du Médicament et des Produits de Santé (ANMPS). Appoint a Importateur tunisien — the AMC applicant and the signatory of the per-importation 'Engagement pour CTI'; no separate local-agent or authorised-representative regime for devices was located.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Agence Nationale du Médicament et des Produits de Santé (ANMPS) including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Agence Nationale du Médicament et des Produits de Santé (ANMPS) reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Agence Nationale du Médicament et des Produits de Santé (ANMPS) may issue questions.

    Duration

    2 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Agence Nationale du Médicament et des Produits de Santé (ANMPS) issues Tunisia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 0 records

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

No maintained record.

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Tunisia certifications →
Slug

tunisia

Market

Tunisia

Confidence

low

Schemes
  • Id

    tunisia-cert-radio-equipment-homologation

    Name

    CERT homologation of radio and telecommunications terminal equipment

    Category

    Radio Spectrum

    Status

    Mandatory Pre Market

    Object

    Radio Equipment

    Note

    Décret gouvernemental n° 2020-48 du 23 janvier 2020, relatif aux procédures d'homologation d'importation et de commercialisation des équipements terminaux de télécommunications et des équipements radioélectriques, is the instrument under which the Centre d'Études et de Recherches des Télécommunications (CERT) homologates telecommunications terminal equipment and radio equipment before import and marketing. The CERT's own published procedure sets out the two steps and their periods: forty-eight hours for the authorisation to withdraw a representative sample, then — from receipt of a complete dossier — three working days for files handled at the guichet unique, seven working days for files transferred to the centre's laboratories, and twenty-one working days where the Agence Nationale des Fréquences must give an opinion, with a three-month maximum for a disputed file. A medical device is caught only where it contains radio transmitting or receiving equipment or terminal equipment attachable to a public network.

    Source Urls
    • https://www.cert.tn/fr/pdf/32.pdf
    Source Binding

    reviewed

  • Id

    tunisia-anmps-conformity-certificate-evidence

    Name

    ANMPS conformity-certificate requirement (CE certificate or ISO 13485)

    Category

    Product Specific Conformity

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Point f.1 of the ANMPS technical-dossier guide makes the conformity certificate a mandatory dossier item and keys it to the device's class: a valid ISO 13485 certificate issued by a certification body for class I devices, and a CE certificate of conformity under Regulation (EU) 2017/745 issued according to the risk class and the requirements of that regulation for every other class. Only certificates issued by notified bodies notified to the European Commission (listed on NANDO) are accepted. Point f.2 provides for devices without a valid MDR certificate: a copy of the Annex VII section 4.3 written agreement between manufacturer and notified body, or a notified-body confirmation letter under Regulation (EU) 2023/607 — Tunisia expressly tracks the EU's own transition extension. Points g and h accept US 510(k)/PMA and a Health Canada medical device licence for devices declaring conformity to those regimes. This is evidence inside the ANMPS evaluation, not a substituted approval: the ANMPS still issues the AMC itself.

    Source Urls
    • https://portail.anmps.tn/sites/default/files/2026-03/T-OP9-003-FR-000-GUIDE%20D%E2%80%99ELABORATION%20D%E2%80%99UN%20DOSSIER%20TECHNIQUE%20DE%20DISPOSITIFS%20MEDICAUX.pdf
    Source Binding

    reviewed

  • Id

    tunisia-anmps-import-technical-control-amc

    Name

    Import technical control at the ANMPS — Autorisation de Mise à la Consommation

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    consignment

    Note

    The operative market-access instrument for devices is the foreign-trade technical control regime — loi n° 94-41 du 7 mars 1994 relative au commerce extérieur and décret n° 94-1744 du 29 août 1994 — not a devices statute: every consignment is subject to import technical control (CTI) at the ANMPS and receives an Autorisation de Mise à la Consommation (AMC), which is an authorisation tied to an importation rather than a product registration certificate with a multi-year validity. ANMPS procedure P-OP2-001-FR §2.4 requires the applicant to sign the 'Engagement pour CTI' form (F-OP2-001-FR), unique for each importation, and to settle the AMC fees, which the procedure states will be fixed by the ANMPS on the basis of an existing tariff for an 'avis technique' or an 'analyse' without the agency necessarily performing either service. §2.2 operates three tracks: a systematic light administrative AMC for products that obtained an AMC after avis within the previous two years, and the technical avis technique and analyse tracks for everything else.

    Source Urls
    • https://portail.anmps.tn/sites/default/files/2025-09/p-op2-001-fr-000-controle-dm-ca-cos-objets-de-puericulture-cti.pdf
    Source Binding

    reviewed

  • Id

    tunisia-cnrp-ionizing-radiation-authorisation

    Name

    CNRP control of installations and sources emitting ionizing radiation

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Source Or Installation

    Note

    Loi n° 81-51 du 18 juin 1981 relative à la protection contre les dangers des sources de rayonnements ionisants (JORT n° 42 du 19 juin 1981), completed by décret n° 86-433 du 28 mars 1986 relatif à la protection contre les rayonnements ionisants, places sources of ionizing radiation under a control regime administered by the Centre National de Radioprotection (CNRP), which studies the application, carries out the control and issues a report and opinion; the applicant files the CNRP's own request form for the study or control. The government service directory publishes the authorisation as taking two months from the date the application is filed. The scheme is bound to the law's official publication card rather than to the instrument text because the CNRP's own texts could not be retrieved and the service directory is served only over http; the requirement's scope for a device that emits ionizing radiation should be confirmed with the CNRP.

    Source Urls
    • https://www.social.gov.tn/fr/loi-n%C2%B0-51-de-1981-du-18-juin-1981-relative-%C3%A0-la-protection-contre-les-dangers-des-rayonnements
    Source Binding

    candidate

Official Sources
  • Authority

    Agence Nationale du Médicament et des Produits de Santé (ANMPS)

    Topic

    guide d'élaboration d'un dossier technique de dispositifs médicaux (T-OP9-003-FR) — class axis and conformity-certificate requirement

    Url

    https://portail.anmps.tn/sites/default/files/2026-03/T-OP9-003-FR-000-GUIDE%20D%E2%80%99ELABORATION%20D%E2%80%99UN%20DOSSIER%20TECHNIQUE%20DE%20DISPOSITIFS%20MEDICAUX.pdf

  • Authority

    ANMPS

    Topic

    procédure de contrôle des dispositifs médicaux, produits cosmétiques et objets de puériculture au CTI (P-OP2-001-FR) — AMC tracks, per-importation undertaking and legal basis

    Url

    https://portail.anmps.tn/sites/default/files/2025-09/p-op2-001-fr-000-controle-dm-ca-cos-objets-de-puericulture-cti.pdf

  • Authority

    ANMPS

    Topic

    agency presentation — creation by loi n° 2023-2 du 12 juillet 2023 and competence over medicines and health products

    Url

    https://portail.anmps.tn/about

  • Authority

    Centre d'Études et de Recherches des Télécommunications (CERT)

    Topic

    procédure d'obtention du certificat d'homologation — steps, processing periods and tariff for applicants resident abroad

    Url

    https://www.cert.tn/fr/pdf/32.pdf

  • Authority

    CERT

    Topic

    prestations et procédures du guichet unique — equipment subject to prior homologation

    Url

    https://www.cert.tn/fr/publication/prestations_et_procedures

  • Authority

    Ministère des Technologies de la Communication

    Topic

    Agence Nationale des Fréquences — textes de référence, including décret gouvernemental n° 2020-48 du 23 janvier 2020

    Url

    https://www.anf.tn/index.php/fr/node/8287

  • Authority

    Ministère des Affaires Sociales

    Topic

    loi n° 81-51 du 18 juin 1981 relative à la protection contre les dangers des sources de rayonnements ionisants (JORT n° 42 du 19 juin 1981)

    Url

    https://www.social.gov.tn/fr/loi-n%C2%B0-51-de-1981-du-18-juin-1981-relative-%C3%A0-la-protection-contre-les-dangers-des-rayonnements

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