Tunisia medical device regulatory resources

ANMPS — not the Direction de la Pharmacie et du Médicament — operates medical-device market access

The competent authority for medical devices in Tunisia is the Agence Nationale du Médicament et des Produits de Santé (ANMPS). ANMPS defines and operates the contrôle technique à l'importat…

Device market access rests on the foreign-trade import technical-control regime, not a devices statute

The operative legal basis for medical device market access in Tunisia is the foreign trade technical control regime, not a device specific law: loi n° 94 41 du 7 mars 1994 relative au comme…

One import-control procedure covers medical devices alongside cosmetics, supplements and childcare articles

The ANMPS import technical control procedure applies to medical devices together with food supplements, cosmetic products and childcare articles, in a single instrument. ANMPS defines the p…

EU MDR classes I, Is, Im, IIa, IIb and III, applied by reference

Class I, Class Is, Class Im, Class IIa, Class IIb, Class III

No standalone device registration yet — market access is a per-importation AMC inside the import technical control

There is not yet a standalone Tunisian medical device registration. Market access runs through the Autorisation de Mise à la Consommation (AMC) issued inside the contrôle technique à l'impo…

Three AMC tracks: administrative (light), avis technique and analyse

ANMPS operates three AMC tracks. Products that obtained an AMC after 'avis' during the previous two years, and products that obtained one after 'analyse' during the previous two years, may…

EU CE marking accepted as the conformity evidence for the ANMPS device dossier

statement: For a device conforming to European Union legislation, ANMPS accepts the EU conformity certificate as the conformity evidence in its device technical dossier: for class I devices…

Free-sale certificate from the country of origin is a mandatory dossier item

statement: A certificat de vente libre (free sale certificate) issued by a competent authority of the country of origin is a mandatory item of the ANMPS device technical dossier, and it mus…

The Tunisian importer is the applicant and its manager personally signs a per-importation undertaking

The applicant for a Tunisian device AMC is the Tunisian importer. For every importation the importer must sign the 'Engagement pour CTI' form (form identifier F OP2 001 FR, annex 1 to the p…

Devices reclassified into customs chapter 30 fall under the State import monopoly and need a prior derogation

Importation of a medical device that customs has reclassified into chapter 30 of the customs tariff is subject to the State import monopoly and requires a prior derogation. ANMPS informed i…

The analyse track adds a lot analysis report and a description of the analysis methods

For a device placed in the 'analyse' track rather than the 'avis technique' track, the dossier must contain, in addition to every document required for an avis technique: a dated and signed…

The avis technique dossier: 13 lettered items from liaison sheet to labelling mock-up

The device technical dossier for the 'avis technique' track is built from the following documents: (a) the fiche de liaison; (b) the Autorisation Provisoire d'Enlèvement (APE); (c) the deta…

APE application dossier follows the ANMPS 'Check-list APE' and is generated from the ANMPS dedicated application

An application for an Autorisation Provisoire d'Enlèvement (APE) for a medical device is filed as a single bound dossier conforming to the 'Check list APE' published on the ANMPS website, s…

CTI file requires the signed 'Engagement pour le CTI' form, reference F-OP2-001-FR, one per importation

To obtain an administrative AMC for a medical device at importation, the importer must sign the form « Engagement pour le CTI », listed as Pièce Jointe 1 of the CTI procedure with identifie…

A labelling mock-up is a required part of the device dossier, with pack-size rules for samples

A labelling mock up is a required part of the Tunisian medical device dossier: item m of the avis technique list requires a mock up of the sales packaging labelling, and item m's pack size…

Class I devices need a valid ISO 13485 certificate; other classes need a CE certificate from a NANDO-listed notified body

The conformity certificate accepted in a Tunisian device dossier depends on risk class. For class I devices (I, Is, Im), the file must carry a valid certificate of conformity to the ISO 134…

ANMPS audits the manufacturing sites of medical devices against good manufacturing practice

Within its quality control mission ANMPS carries out audits of the manufacturing sites of medicines and of medical devices. These inspections verify that installations and manufacturing pro…

CERT homologation of radio and telecommunications terminal equipment

Wireless / radio

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

Product-specific

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

Import CoC / PVoC

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

CERT authorisation to withdraw a representative sample for homologation · 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

2 days

CERT homologation certificate — radio and telecommunications terminal equipment · Homologation by the CERT services on an application filed with the guichet unique (décret gouvernemental n° 2020-48 du 23 janvier 2020)

3-21 working days

No published AMC validity period — a rolling two-year evidentiary window instead

No AMC validity period is published for medical devices. The instrument's logic is a rolling two year evidentiary window rather than a stated expiry: products that obtained an AMC after 'av…

Certification, composition, process, packaging or labelling changes push a product back to technical control

A change disqualifies a product from the light administrative AMC track and sends it to control by the ANMPS technical services at the next importation, until a satisfactory evaluation repo…

The manufacturer's declaration of conformity must carry the lot number or another unique reference enabling identification and traceability

The manufacturer's declaration of conformity filed in a Tunisian device dossier must state, as a minimum, the manufacturer's name and address and the product's trade name, product code and…

The manufacturer's declaration of conformity must state the Basic UDI (IUD-ID), with its correspondence shown

The manufacturer's declaration of conformity filed in a Tunisian device dossier must state the Basic Unique Device Identifier — « Identifiant Unique des Dispositifs de base (IUD ID) ». Wher…

Clinical trials on medical devices need an ANMPS authorisation, with ethics-committee and INPDP opinions

ANMPS is the body charged with framing and issuing the authorisations needed to conduct clinical trials on medicines, medical devices and other health products. Sponsors, investigators and…

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

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

A serious vigilance incident anywhere in the world bars the light AMC track

A serious vigilance incident internationally is a bar to the light administrative AMC track: the product is returned to control by the ANMPS technical services at the next importation until…

Device market surveillance is run as matériovigilance plus complaint handling, as an ANMPS activity

ANMPS's vigilance and market surveillance activity is organised by product family: « Matériovigilance » for medical devices, pharmacovigilance for medicines and cosmétovigilance for cosmeti…

ANMPS holds the prerogative to control information and advertising on health products, a term that includes devices

Control of information and advertising concerning medicines and health products, and communication of relevant information to professionals and patients, is one of ANMPS's stated prerogativ…

ANMPS may require device-dossier documents beyond those the published guide lists

The ANMPS device technical dossier guide closes its document list with an express reservation: « Par nécessité, l'ANMPS se réserve le droit de demander d'autres documents que ceux décrits c…