Agence Nationale du Médicament et des Produits de Santé (ANMPS) F-MG1-002-FR,F-MG1-002-FR, Rev 000
F-MG1-002-FR, Rev 000 is the official ANMPS identifier for “Note d'information à l'attention des importateurs — révision du statut des dispositifs médicaux à base d'acide hyaluronique”. F-MG1-002-FR, Rev 000 is the official identifier ANMPS uses for this instrument.
- Instrument
- F-MG1-002-FR,
- Full name
- F-MG1-002-FR, Rev 000
- Category
- General
- Authority source
- French
- Readable HTML
- 0 articles · 1 language version
- Published
- 3 October 2025
- Effective
- —
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Note d'information à l'attention des importateurs — révision du statut des dispositifs médicaux à base d'acide hyaluronique
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.
F-MG1-002-FR, Rev 000 is the official identifier ANMPS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.