Tunisia medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• 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.

Reviewed 2026-09-16. End-to-end totals remain planning estimates.