🇹🇳 Tunisia medical device regulatory data

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 prerogatives. The same page defines the products over which the agency acts to include medical devices: ANMPS was created by Loi n° 2023-2 du 12 juillet 2023 and acts on human and veterinary medicines, medical devices, food supplements, cosmetic products and all other health products aimed at prevention, diagnosis or care before and after their placing on the market. The agency also lists supervision of medical-promotion agencies among its inspection activities.

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 'avis' or after 'analyse' during the previous two years qualify for the systematic administrative AMC, and to obtain the administrative AMC the importer must attach the AMCs obtained during the previous two years. The only twelve-month validity located in an ANMPS device-related note attaches to a customs State-monopoly derogation for reclassified hyaluronic-acid products, not to an AMC.

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'importation (CTI) procedure through which a medical device obtains its Autorisation de Mise à la Consommation (AMC), and it describes 'Contrôle technique à l'importation (AMC)', 'Contrôle des dispositifs médicaux et des compléments alimentaires' and 'Matériovigilance pour les dispositifs médicaux' as its own activities. ANMPS is a public establishment of a non-administrative character with legal personality and financial autonomy, under the tutelage of the Ministry of Health, created by loi n° 2023-2 du 12 juillet 2023, which places medical devices within its field of competence. The Directorate of Pharmacy and Medicines (DPM) still appears as a distribution channel and as a linked legacy site, not as the decision-maker.

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 report or a compliant analysis report is obtained. The disqualifying changes are a modification concerning: the composition of the products (ingredients, formulation or materials); the manufacturing processes; the certifications (change of, or acquisition of a new, conformity certificate) or technical analyses; or the packaging, labelling and instructions for use. The other disqualifiers are: a non-compliance during previous importations in the preceding two years; an AMC granted subject to an undertaking requiring verification by the ANMPS technical service; a serious vigilance incident internationally; a pending complaint from users or consumers in Tunisia; or a pending request for further information by letter on a lot filed during a previous importation.

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.

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 clinical-research organisations must submit a complete dossier containing the study protocol, information on the product studied and the documents relating to patient safety; a rigorous evaluation is carried out before any approval, in collaboration with experts in ethics and clinical methodology. The documented decision chain is: online filing of the dossier; validation of the contract by all the entities concerned; opinion of the president of the CPP (personal-protection committee) or of the ethics committee for non-medicinal products; opinion of the president of the INPDP; opinion of ANMPS and external experts; validation of the clinical-trial registration or rejection of the application; notification of the applicant and the stakeholders.

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 procedure's object as the control of medical devices, cosmetic products and childcare articles within the framework of the technical control at importation, and the procedure is written as one document with separate branches for cosmetics and supplements on one side and medical devices and childcare articles on the other.

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 lot analysis report including the tests performed, the acceptability intervals of the specifications and the normative reference associated with each test; and a detailed description of the analysis methods. Where the finished product's specifications at expiry differ from those at release, both must be provided with their acceptability intervals.

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 detailed purchase invoice describing all the products concerned; (d) the free-sale certificate from the country of origin; (e) the manufacturer's declaration of conformity; (f.1/f.2) the EU conformity certificate or its MDR-transition alternative; (g) or the US conformity document; (h) or the Canadian licence; (i) the physico-chemical and microbiological analysis report for non-solid forms; (j) the sterility attestation for sterile devices; (k) the biocompatibility attestations; (l) the animal-origin attestations; (m) the labelling mock-up. The APE (Autorisation Provisoire d'Enlèvement) is therefore a required filing document alongside the conformity evidence.

The manufacturer's declaration of conformity in the Tunisian device dossier must state at least: the manufacturer's name and address; the product's trade name, product code, lot number or any other unique reference allowing identification and traceability of the device covered by the declaration of conformity; the Basic UDI-DI (IUD-ID); a declaration of which legislation the device complies with (the example given is Regulation (EU) 2017/745 or other); the place and date of issue plus the signatory's name and full details; the reference to the ISO and EN standards to which the device is declared conform; the device's risk class (I, Is, Im, IIa, IIb, III); and, where applicable, the notified body's name and identification number, a description of the conformity-assessment procedure followed and the reference of the certificate(s) issued.

Beyond the regime-level conformity certificate, the Tunisian device dossier requires product-type-specific evidence. For non-solid devices (solution, gel, cream, paste): the physico-chemical and microbiological analysis report for the finished product for each lot, stating the acceptance interval of the specifications for each test, dated and signed by a responsible person, plus the complete qualitative and quantitative composition — and where CMR substances are present the manufacturer must comply with Annex I, Chapter II, point 10.4 of Regulation (EU) 2017/745. For sterile devices: an attestation of sterility stating the lot numbers and expiry dates of each article, the normative reference of the sterilisation process, and the date and visa of the responsible person; a sterility test result on an analysis report may be accepted. For biocompatibility: ISO 10993-1 attestation for all devices, ISO 10993-7 for ethylene-oxide-sterilised products and ISO 10993-11 for pyrogen-free products, each established by the manufacturer. For animal-origin devices (collagen, bone): ISO 22442 and/or Regulation (EU) 722/2012 attestation established by the manufacturer.

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 procedure), and ANMPS issues the administrative AMC only after the importer presents a copy of the payment receipt and the undertaking signed by the gérant (manager) of the importing company. That is an enforceable named-officer commitment, not an anonymous corporate filing. ANMPS's registration service page adds that either manufacturers or importers submit the design, manufacturing and performance information and the international conformity certificates.

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 importers that, following revision of the status of hyaluronic-acid-based medical devices, the competent customs services reclassified them under tariff heading 30049000 of the customs nomenclature, corresponding to products falling under chapter 30 of the customs tariffs, so that their importation is now subject to the State monopoly; to unblock import procedures, a derogation from the State monopoly (document code 120) must first be granted by the Ministry of Health — Agence Nationale du Médicament et des Produits de Santé. The derogation is valid for twelve months from 25 August 2025.

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 rules are specific — for individual and multiple packs containing at most 10 articles, the samples must be supplied in their secondary sales packaging; for multiple packs containing more than 10 articles, secondary packaging is not necessary and only a mock-up or a copy of the secondary-packaging labelling may be supplied. The same duty appears on the import side: the administrative AMC requires a copy of the labelling (labelling mock-up) or any other document identifying the articles by trade name.

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 commerce extérieur, which defines the foreign-trade regime applicable to import and export operations and the technical-control arrangements and the bodies empowered to exercise them, and décret n° 94-1744 du 29 août 1994 relatif aux modalités de contrôle technique à l'importation et à l'exportation et aux organismes habilités à l'exercer. ANMPS's device import-control procedure names those two instruments as its references, and the only device-specific legal texts ANMPS lists among its regulatory texts are narrow sectoral instruments (for example the joint arrêté of 30 December 2020 fixing the technical specifications of masks).

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, structured in two parts: part one holding the documents the check-list requires for the APE, part two holding the documents needed for the administrative AMC (signed commitments, AMCs issued after an analysis bulletin and less than two years old, with the corresponding invoices where the references do not appear on the AMCs). The application form is not a blank government form: the importer completes it on the ANMPS dedicated application and then prints it, stating the references eligible for an administrative AMC. Product references are entered in the « Références » section of the ANMPS platform. A labelling mock-up must be joined where the AMCs or invoices do not clearly establish that the products are the same.

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 identifier F-OP2-001-FR, one single such engagement for each importation, and must also hold a technical dossier conforming to the requirements, pay the AMC fee, attach the AMCs obtained during the previous two years, and provide a copy of the labelling (labelling mock-up) or any other document identifying the articles by trade name.

The import technical-control (CTI) activity for medical devices was transferred from the Laboratoire National du Contrôle des Médicaments (Beb Saadoun) to ANMPS headquarters. From 20 April 2026 the whole CTI service and its staff operate at 40, Rue Hedi Nouira 1023, Tunis, and all correspondence, administrative steps and visits must be made exclusively at that new address. The deposit of samples and of the documentation required for evaluation, and the payment of the fees, remain at the Laboratoire National du Contrôle des Médicaments (Beb Saadoun).

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 13485 standard issued by a certification body. For every other device, it must carry a CE certificate of conformity matching the risk class of the device and the requirements of Regulation (EU) 2017/745. Only CE certificates issued by notified bodies notified to the European Commission (those listed on the NANDO site) are accepted. Where no valid MDR CE certificate exists, the file carries instead a copy of the written agreement under Annex VII section 4.3 second paragraph of Regulation (EU) 2017/745 signed between the manufacturer and the notified body, or a letter from the notified body confirming the status of a formal application, the written agreement and appropriate surveillance under Regulation (EU) 2023/607.

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 processes conform to good manufacturing practice (BPF). The audits cover an evaluation of the infrastructures, the production methods and the quality-control systems; at the end of each inspection a report is drawn up together with recommendations or corrective measures where necessary.

ANMPS's vigilance and market-surveillance activity is organised by product family: « Matériovigilance » for medical devices, pharmacovigilance for medicines and cosmétovigilance for cosmetic products, together with « Gestion des réclamations » (complaint handling). Device market surveillance is therefore a distinct named activity of the agency rather than a branch of medicines vigilance.

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'importation (CTI), and ANMPS states its own purpose as reducing the time needed to obtain the AMC 'with a view to a transition towards a registration'. The AMC is tied to the importation: the importer signs an 'Engagement pour CTI' undertaking that is unique to each importation. ANMPS's device 'Enregistrement des dispositifs médicaux' service page carries no published procedure, no fee ('NA'), no average timeline ('NA') and an empty required-documents list, which is consistent with a registration regime not yet in operation.

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 obtain a systematic 'administrative' AMC. The administrative AMC requires: a technical dossier compliant with the requirements on file; payment of the AMC fees to ANMPS at the existing 'avis technique' or 'analyse' tariff although ANMPS performs neither service; the 'Engagement pour CTI' form signed once per importation; the AMCs obtained during the previous two years attached; and a copy of the labelling mock-up or any other document identifying the articles by trade name. ANMPS issues the administrative AMC only on presentation of the payment receipt and of the undertaking signed by the manager of the importing company.

For medical devices of animal origin (collagen, bone, …) the file must contain an attestation of conformity to the ISO 22442 standard and/or an attestation of conformity to Regulation (EU) 722/2012, drawn up by the manufacturer.

Item k (Biocompatibilité) of the avis-technique dossier requires: (1) an attestation of conformity to ISO 10993-1 for all devices, drawn up by the manufacturer; (2) an attestation of conformity to ISO 10993-7 for products sterilised with ethylene oxide, drawn up by the manufacturer; and (3) an attestation of conformity to ISO 10993-11 for apyrogenic products, drawn up by the manufacturer.

The manufacturer's declaration of conformity required in every device file must state, among its minimum contents, the reference to the standards (ISO, EN) to which the device is declared conformant. Where a device is placed in the 'analyse' control track, the dated and signed lot analysis bulletin must include the tests performed, the acceptance intervals of the specifications and the normative reference associated with each test, together with a detailed description of the analytical methods; if end-of-shelf-life specifications differ from release specifications they must also be supplied.

For sterile devices the file must contain a sterility attestation stating the lot numbers and expiry dates of each article, the normative reference of the sterilisation process, and the date and visa of the responsible person. The guide notes that the result of a sterility test stated on an analysis bulletin may be accepted.

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 ci-dessus. » A filer therefore cannot treat the published list as exhaustive, and a query or deficiency on a device dossier can lawfully extend to documents the guide does not name.

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 lot number, or any other unique reference allowing the device covered by the EU declaration of conformity to be identified and traced. The declaration must also state which legislation the device complies with (for example Regulation (EU) 2017/745), the place and date of issue and the signatory's name and full details, the standards (ISO, EN) to which the device is declared conform, the risk class of the device (I, Is, Im, IIa, IIb, III) and, where applicable, the notified body's name and identification number, a description of the conformity-assessment procedure followed and the reference of the certificate(s) issued.

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) ». Where the products are identified by their Basic UDI, their correspondence must be shown if it is not already indicated on the declaration of conformity. The Basic UDI is thereby an entry on the device's filing document rather than a separate Tunisian UDI database record.

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 a satisfactory evaluation report or a compliant analysis report is obtained. Tunisia's vigilance criterion is therefore expressly extraterritorial — it is not limited to incidents occurring on Tunisian territory. ANMPS holds the materiovigilance function for medical devices, listed as a distinct agency activity alongside pharmacovigilance and cosmétovigilance, with complaint management, and it also lists market surveillance, inspection including good-manufacturing-practice control, and quality control of medical devices among its activities.