Law 18-11 Articles 212 and 213: Device and IVD Definitions

1. Key takeaways

Algeria writes devices and in vitro diagnostic devices into two separate definition articles: Article 212 defines devices, and Article 213 defines IVDs on their own terms. Nothing in the law merges the two categories, so every product must first be measured against the correct article before any regulatory step is taken.

Article 212 contains five core elements: instruments, apparatus, equipment, materials or products (excluding products of human origin) or other items; used alone or in combination; including accessories and software involved in their operation; intended for human use; and intended for a medical purpose.

Article 213 adds, for IVDs, six categories of subject matter (reagents, products, materials, instruments and systems, their components and accessories, and specimen receptacles) together with four purposes (physiological or pathological states, congenital abnormalities, monitoring therapeutic measures, and determining the safety of collected specimens or their compatibility with the recipient).

These two definition articles are the gatekeepers of the entire Algerian pathway. Everything downstream — classification, dossier content, evaluation depth — depends on getting the definitional analysis right at the beginning, and GRZAN treats the written device determination as the first deliverable of every project.

2. Legal basis

1. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 18 Chaoual 1439 corresponding to July 2, 2018 on health, JORADP No. 46, published 2018-07-29), Article 212 (definition of devices) and Article 213 (definition of in vitro diagnostic devices).
2. 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 6 Rabie Ethani 1442 corresponding to November 22, 2020 on the modalities of homologation of medical devices, JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 17 (four risk classes I, IIa, IIb, III based on potential patient risk).
3. 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 28 Ramadhan 1442 corresponding to May 10, 2021 fixing the composition of the homologation dossier and of the renewal dossier of the homologation decision for medical devices for human medicine, JORADP No. 55, published 2021-07-14, pages 21–24, 13 articles), Article 4 (the dossier must state the designation, characteristics, composition, classification and classification rules of the device).
4. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 11 Rajab 1442 corresponding to February 23, 2021 on pharmaceutical establishments and the conditions of their agrément, JORADP No. 14, published 2021-02-28, pages 9–12, 29 articles), Article 2 (all five categories of pharmaceutical establishments cover both pharmaceutical products and devices).

3. Expert insights

Insight one: software is written into the definition, not mentioned as an aside.

Article 212 uses the wording that the definition includes its accessories and the software intervening in its operation (y compris les accessoires et logiciels intervenant dans son fonctionnement). This means that standalone software in Algeria falls within the device definition and follows the same homologation pathway, with no separate classification or exemption route. GRZAN’s handling is to classify software products directly under the four classes of Article 17; no special software track is assumed to exist.

Insight two: products of human origin are excluded from the device definition.

The exclusion in Article 212 covers products of human origin (à l’exception des produits d’origine humaine). Note that the exclusion applies to products, not to devices that merely contain human-origin components. The latter remain devices; they are simply flagged in the dossier under Article 4 of the May 10, 2021 Ministerial Order as devices containing a medicinal substance, blood components, materials of animal origin, or latex and phthalates, and that flagging must be made separately and explicitly.

Insight three: the specimen receptacle in the IVD definition is easily overlooked.

Article 213 lists specimen receptacles (récipients pour échantillons) alongside reagents and instruments. This means that blood collection tubes, specimen cups and similar containers are themselves IVDs and require their own homologation; they cannot piggyback on the main device as mere accessories. Product teams that bundle consumables with an analyzer should split these items out at the SKU level.

Insight four: the definitions leave a doorway to international convergence.

Article 17 of Décret exécutif n° 20-324, in setting out the four classes, states that account is taken of the evolution of international consensus (en tenant compte de l’évolution du consensus international). GRZAN therefore takes the position that, where classification is disputed, citing IMDRF or EU classification rules as supporting reasoning is accepted by the text itself. That phrasing is an argumentation tool, not a borrowing of a foreign regime wholesale.

4. Practical recommendations

1. Compare the product element by element against the five elements of Article 212 and produce a written device determination, to be used as the foundational document of the first part of the dossier.
2. Issue a separate determination for software products, stating precisely how the software intervenes in the operation of the device.
3. Assess IVD product lines SKU by SKU, paying particular attention to whether specimen receptacles fall under Article 213.
4. Where the product contains a medicinal substance, components of animal origin, or latex and phthalates, flag it in the designation item of the dossier under Article 4 of the dossier order.
5. When classification is contested, prepare comparison materials based on IMDRF or EU classification rules and cite the evolution of international consensus wording in Article 17.
6. Translate the determination into French as the primary text for communication with the ANPP; Arabic is used for labels and packaging mock-ups.

5. Verification checklist

• □ A written device determination has been issued against the five elements of Article 212.
• □ Software products have a separate explanation of how they intervene in operation.
• □ Specimen receptacles in the IVD line have been assessed item by item against Article 213.
• □ Products containing medicinal substances, animal-origin components, or latex and phthalates are flagged in the dossier designation item.
• □ The classification conclusion states the classification rules, and international comparison materials are ready.
• □ The determination exists in a French version, and labels and mock-ups exist in an Arabic version.

Related reading in this series

• Article 05, The four-class classification of devices in Algeria: Classe I, IIa, IIb, III — https://www.grzanglobal.com/algeria-medical-device-registration/algeria-device-classification-class-i-iia-iib-iii/
• Article 26, Declarations for four special device categories: medicinal, active implantable, IVD, custom-made — https://www.grzanglobal.com/algeria-medical-device-registration/special-device-categories-declarations/
• Article 21, The five parts of the homologation dossier: Article 5 of the May 10, 2021 Ministerial Order — https://www.grzanglobal.com/algeria-medical-device-registration/dossier-five-parts-article-5/

Regulatory information verified as of October 30, 2026.

GRZAN supports device and IVD manufacturers in Algeria with definition and classification analysis, homologation dossier preparation and ANPP communication in French and Arabic. For professional regulatory and compliance assistance in the Algerian market, contact info@grzanglobal.com.