The four special device categories and their dossier declarations

1. Key takeaways

The last item of Article 4 of the Ministerial Order of 10 May 2021 requires the dossier to designate the device (désignation) as belonging to one of four categories: devices containing medicinal substances, blood or blood-derived components, components of animal origin, or latex and phthalates; active implantable devices; in vitro diagnostic devices; custom-made devices.

This is not a formal annotation. Devices containing medicinal substances must be accompanied by three additional data sets — indications, contraindications and adverse reactions — and the remaining categories are expressly listed in Article 6 among the device types to which the 5-part dossier format applies. The designation therefore drives both the content of the dossier and the depth of the technical evaluation.

The practical estimate applied by GRZAN is that the designation exercise should be performed per SKU, not per product family, because a single component decision — a phthalate plasticiser in one tubing lot, a latex valve in one variant — changes the designation and with it the review expectations.

2. Legal basis

1. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the four-category designation; for devices with medicinal substances, the additional indications, contraindications and adverse reactions); Article 6 (the format applies to all device types, in particular IVDs and active implantable devices).
2. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 2 July 2018 on health, JORADP N° 46, published 2018-07-29): Articles 212 and 213 (the definitions of devices and IVDs).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 25 (the four phases of technical evaluation).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the dossier must state the classification and the classification rules).

3. Expert insights

Insight one: the first category is in fact a combined designation covering five substances.

The first category of Article 4 lists devices containing medicinal substances, blood or blood-derived components, components of animal origin, latex and phthalates. Five substances share a single designation item, which means the self-check must screen for each substance individually, with particular attention to latex and phthalates, which sit at the excipient and material level rather than the therapeutic level. Devices are frequently designed without anyone asking whether a gasket, a tube or a reservoir contains a phthalate, and the answer surfaces only when the designation form forces the question.

Insight two: devices with medicinal substances are the only category with three mandatory additional data sets.

Item 9 of Article 4 requires devices containing medicinal substances to provide the indications, contraindications and adverse reactions. These three items are the clearest case of pharmaceutical documentation logic penetrating the device dossier, and they are the primary objects of review in the fourth phase of the technical evaluation under Article 25 of Executive Decree No. 20-324, the assessment of clinical data. Article 10 repeats the same requirement for the renewal dossier, so the three data sets must be maintained, not merely filed once.

Insight three: IVDs and active implantable devices are named separately in Article 6, which means the format cannot be simplified.

The second paragraph of Article 6 states that the format also applies to all types of devices, in particular in vitro diagnostic devices and active implantable devices. The purpose of that sentence is to exclude the misconception that IVDs may use a simplified dossier. IVDs follow the same 5-part format, with no relief granted because of a lower classification. For teams used to markets where IVD documentation is lighter, this is the single most important scoping fact to communicate internally before the project starts.

Insight four: custom-made devices are listed in the designation, but no derogation is attached.

Article 4 places the custom-made device (dispositif médical sur mesure) among the designation items, yet the current text provides no simplified route or exemption for them. The GRZAN reading is that custom-made devices in Algeria still go through homologation; only the dossier content is tailored case by case. This differs from jurisdictions where custom-made devices enjoy a declaration-only route, and it means project timelines for patient-matched or patient-specific products should be built on the full registration assumption, pending verification of any future text introducing a dedicated route.

4. Practical recommendations

1. Build an eight-cell self-check table covering the five substances and the three categories, and tick it per SKU.
2. Prepare the indications, contraindications and adverse reactions as three separate data sets for devices with medicinal substances.
3. Prepare IVDs and active implantable devices in the full 5-part format, with no simplification.
4. Tailor the dossier content for custom-made devices case by case, but keep them on the homologation path.
5. State the four-category designation on the dossier cover page and mirror it in the classification explanation.
6. At renewal, re-check whether the designation has changed, and route any change through the modification procedure.

5. Verification checklist

• □ The eight-cell self-check table has been completed per SKU.
• □ The three additional data sets for devices with medicinal substances are ready.
• □ IVDs and active implantable devices have been prepared in the full 5-part format.
• □ The case-by-case tailoring plan for custom-made devices has been set.
• □ The four-category designation appears on the cover page and in the classification explanation.
• □ Designation changes at renewal have been planned through the modification procedure.

• Article 25 — Packaging mock-ups and labelling: the mandatory Arabic wording: https://www.grzanglobal.com/algeria-medical-device-registration/labelling-arabic-language-requirements/
• Article 02 — Articles 212 and 213 of Law 18-11: the statutory definition boundaries of devices and IVDs: https://www.grzanglobal.com/algeria-medical-device-registration/law-18-11-article-212-213-device-ivd-definitions/
• Article 05 — The four-level classification of Algerian devices: Classe I, IIa, IIb, III: https://www.grzanglobal.com/algeria-medical-device-registration/algeria-device-classification-class-i-iia-iib-iii/

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, including special-category designation screening and medicinal-substance device documentation. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.