Consequences of Marketing Medical Devices without a Homologation Decision

1. Key takeaways

Article 16, first paragraph, of Décret exécutif n° 20-324 establishes the principle of mandatory homologation: any ready-to-use, industrially manufactured device that is imported or exported may be placed on the market only under an ANPP homologation decision.

Article 230 of Loi 18-11 repeats the same duty at the level of the law.

The consequences of breach unfold along two lines. Procedurally, Article 41 requires withdrawn devices to cease distribution and their batches to be recalled, destroyed or returned. Substantively, Article 31, fifth item (documents not meeting the requirements of the decree) is a ground of refusal.

The order of 20 February 2025 provides a buffer with a time ceiling, examined below.

Taken together, the picture is clear: marketing without a homologation decision is unlawful by default, the transitional authorisation is temporary and will expire, and the cost of non-compliance is not limited to fines — it extends to stopping sales, disposing of batches and losing the ability to supply the Algerian market at all.

2. Legal basis

1. 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 22 November 2020 on the modalities of homologation of medical devices, JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 16 (marketing requires homologation; devices manufactured locally and destined exclusively for export are governed by a separate order).
2. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Health Law No. 18-11 of 2 July 2018, JORADP No. 46, published on 29 July 2018), Article 230 (registration or a homologation decision must be obtained before marketing).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 41 (cessation of distribution and disposal of batches, and who bears the cost) and Article 31 (five grounds of refusal).
4. Arrêté du 21 Chaâbane 1446 correspondant au 20 février 2025 autorisant la commercialisation des dispositifs médicaux (Order of 20 February 2025 authorising the marketing of medical devices, JORADP No. 13, published on 25 February 2025, page 24, 2 articles in total), Article 1 (devices not yet holding a homologation decision are authorised for marketing for 2 years, counted from publication).

3. Expert insights

Insight 1: the four qualifying words of Article 16 define the reach of the duty.

Article 16, first paragraph: the homologation duty is triggered only where a device is simultaneously ready to use (prêt à l’emploi), industrially manufactured (fabriqué industriellement), imported or exported, and placed on the market (mise sur le marché). Article 16, second paragraph, assigns devices that are manufactured locally and destined exclusively for export to a separate order — namely the order of 23 June 2021 — so the general duty does not cover them.

Insight 2: the duty is written once at the level of the law and once at the level of execution — this is a foundational obligation.

Article 230 of Loi 18-11 establishes at the legal level that registration or a homologation decision must be obtained before marketing; Article 16 of Executive Decree No. 20-324 details it at the executive level. The fact that both layers state the duty means it cannot be bypassed through administrative practice, and any enforcement argument against it fails at the first step.

Insight 3: the exact meaning of the 2025 buffer is authorisation to sell, not exemption from homologation.

The order of 20 February 2025 is titled “authorising the marketing of medical devices” and grants devices that do not yet hold a homologation decision a 2-year marketing authorisation. It does not repeal Article 16 and does not amend Article 31. Once the window closes, devices still without a homologation decision lose their legal basis for sale, and the ordinary enforcement consequences resume in full.

Insight 4: under Article 41 the disposal costs fall on the holder and/or the operator.

Article 41: after withdrawal, distribution must cease and the batches must be recalled, destroyed or returned, at the expense of the holder and/or the operator. Read with the joint responsibility of Article 9 of Executive Decree No. 21-82, the two parties are jointly liable externally, while the internal split follows the delegation contract between them. For importers, this means the exposure does not end at the border: every unit already sold may still have to be traced, recovered and paid for.

4. Practical recommendations

1. Apply the four qualifying words of Article 16 SKU by SKU to determine whether the homologation duty is triggered.
2. Maintain a list of products on sale without a homologation decision and work backwards against the expiry date of the 2025 window.
3. File devices manufactured locally and destined exclusively for export separately under the order of 23 June 2021, rather than stretching the ordinary pathway to cover them.
4. Reserve, in the budget, the potential batch disposal costs of Article 41.
5. State the internal allocation of non-compliance costs explicitly in the delegation contract.
6. Review the list periodically: move certified SKUs out and add newly introduced SKUs in.

5. Verification checklist

• □ The four qualifying words of Article 16 have been applied SKU by SKU.
• □ The list of products on sale without a homologation decision exists, with a backward plan against the window expiry date.
• □ Export-only, locally manufactured devices are filed under the dedicated pathway.
• □ Batch disposal costs are reserved in the budget.
• □ The internal allocation rule for non-compliance costs is written into the contract.
• □ A periodic review mechanism for the list exists and is being executed.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: gap assessments against the mandatory-homologation principle, use of the 2025 transitional window, management of withdrawals and recalls, and inspection responses. For post-market compliance support in Algeria, contact info@grzanglobal.com.