Tunisia medical device regulations

P-OP2-001-FR, revision 000 of 5 June 2025, by the ANMPS — the procedure for the technical control at importation of medical devices, food supplements, cosmetic products and childcare articles. Two numbered sections: section 1 presents the document (object, entry into force, references, responsibilities and distribution) and section 2 describes the control, separating cosmetics and food supplements (2.1) from medical devices and childcare articles (2.2), and within the device route separating what is subject only to a technical opinion (2.2.1) from what is subject to a systematic analysis (2.2.2), followed by the conditions for applying the procedure (2.3) and the conditions for obtaining an administrative import authorisation (2.4). A 'Pièce Jointe' block carries the attachment the procedure refers to. This is the instrument that decides what happens to a device consignment at the Tunisian border, and it is the counterpart to the customs-side rules the ANMPS note on hyaluronic-acid devices also touches.

T-OP9-003-FR, version 000, issued 26 February 2026 and applicable from 2 March 2026, by the ANMPS — the guide to building the technical file for a medical device. Two numbered sections under the Agency's standard cover: section 1 presents the document (its object, scope, entry into force, references and the responsibilities it allocates), and section 2 is the substance — the documents required for device control, first in the technical-opinion route (2.1) and then in the device-analysis route (2.2). It ends with the version history and the validation block, which name the document's writers and approvers. The extract follows the document's own contents page, so the section ids are the document's own numbers, and its version history table (version 000, création, application 02/03/2026) is carried as its own block.

F-MG1-002-FR, revision 000 — an information note addressed to importers, announcing that following the revision of the status of medical devices based on hyaluronic acid, Tunisian customs has reclassified them under tariff heading 30049000 of the customs nomenclature, in chapter 30 of the tariff. The consequence the note states is that importing these products is now subject to the State monopoly, and that a derogation from the State monopoly (document code 120) must first be obtained from the Ministry of Health through the ANMPS; the note adds that the derogation is valid for twelve months from 25 August 2025. It is a tariff and import-route notice rather than a device-approval rule, and it is the reason a hyaluronic-acid filler importer cannot treat the product as an ordinary registered device. The note's own letterhead date field reads "Date 16/05/2025" while the letter itself is dated "Tunis, le 03/10/2025"; the letter date is recorded here, because the note's own content — a twelve-month derogation running from 25 August 2025 — cannot predate it, and both dates are visible in the extract.