Homologation vs Enregistrement in Algeria

1. Key takeaways

Article 230 of Loi 18-11 writes two parallel market pathways into the same sentence: pharmaceutical products follow registration (enregistrement), while devices follow homologation. Both decisions are issued by the ANPP, but the applicable texts, the commissions, the dossier formats and the validity rules are entirely different.

On the device side, the operative instrument is Décret exécutif n° 20-324 together with four ministerial orders of 2021. On the pharmaceutical side, the counterpart is Décret exécutif n° 20-325, signed on the same day and published in the same issue of the official journal.

GRZAN’s working principle is simple: first determine, under Articles 212 and 213 of Loi 18-11, whether the product is a device, and only then decide which pathway applies. Combination products such as drug-device combinations must be covered by both sets of logic within a single dossier, because the regulator will read them against both regimes.

The two regimes were legislated as twins, not as a main regime with an annex for devices. Treating the device pathway as a variant of drug registration is the most common and most expensive planning error seen in Algerian projects.

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 230 (the two pathways of registration and homologation) and Articles 212 and 213 (definitions of devices and IVDs).
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 1 (the decree governs the modalities of device homologation, the tasks of the commission, and the granting, renewal, withdrawal, transfer and assignment conditions of decisions).
3. Décret exécutif n° 20-325 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’enregistrement des produits pharmaceutiques (Executive Decree No. 20-325 of 6 Rabie Ethani 1442 corresponding to November 22, 2020 on the modalities of registration of pharmaceutical products, JORADP No. 69) — the registration pathway for pharmaceutical products, running in parallel with device homologation.
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 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 (drug-device combinations must be declared in the dossier with the addition of indications, contraindications and adverse reactions).

3. Expert insights

Insight one: the two pathways are twin regimes legislated on the same day.

Décrets n° 20-324 and n° 20-325 are both dated 6 Rabie Ethani 1442 (November 22, 2020) and both published in JORADP No. 69. This synchronized drafting shows that the legislator deliberately designed the two pathways side by side rather than hanging devices under the pharmaceutical regime. The practical consequence is direct: registration experience with drugs cannot be transposed onto devices, because the texts, criteria and forms differ at every step.

Insight two: there are two commissions with different expert composition.

The commission composition in Article 3 of Décret exécutif n° 20-324 includes, beyond pharmaceutical representatives, experts in physics, chemistry and biophysics, metrology, biomedical engineering, and clinical or biology specialists. The pharmaceutical commission is oriented toward pharmacy and clinical medicine. This difference explains why technical parameters and performance data carry far more weight in a device dossier than in a drug registration file, and why reviewers on the device side ask different questions.

Insight three: drug-device combinations are the only crossing point, and the requirements are stricter.

Article 4 of the May 10, 2021 Ministerial Order requires devices containing a medicinal substance to provide additionally three items: indications, contraindications and adverse reactions. Ordinary device dossiers have no such items. GRZAN reads these three items as pharmaceutical logic penetrating the device dossier, and prepares them with pharmaceutical-grade data depth rather than marketing-level summaries.

Insight four: validity and renewal rules are independent for each pathway.

The device homologation decision is valid for 5 years under Article 34 of Décret exécutif n° 20-324 and must be renewed 90 days in advance under Article 35. Pharmaceutical registrations follow the provisions of Décret exécutif n° 20-325 itself. A company holding both device and drug approvals cannot manage them on one shared calendar; the clocks, the deadlines and the renewal triggers are different legal creatures.

4. Practical recommendations

1. At project start, issue a written determination of drug versus device, and flag drug-device combinations explicitly as a crossing category.
2. While preparing the ordinary device dossier for a combination product, prepare the three additional items — indications, contraindications and adverse reactions — as a separate work package.
3. Do not copy the CTD format used for drug registration onto a device dossier; devices use the five-part format of Article 5 of the 2021 dossier order.
4. Maintain separate validity and renewal calendars for the two product categories, without sharing reminders.
5. When communicating with the ANPP, cite explicitly the legal pathway the product follows, so that the reviewer does not request documents from the other checklist.
6. For combination products, anticipate that technical evaluation may simultaneously trigger the physicochemical, biological and clinical data assessment of Article 25; prepare the data once, completely, rather than in waves.

5. Verification checklist

• □ A written determination has been issued stating whether the product follows homologation or registration.
• □ For drug-device combinations, the three additional items — indications, contraindications and adverse reactions — have been prepared separately.
• □ The dossier has been assembled in the device-specific five-part format, not in CTD.
• □ Validity and renewal calendars have been established separately for the two categories.
• □ Correspondence cites the legal basis pathway for each product.
• □ Physicochemical, biological and clinical data for combination products have been prepared in full under Article 25.

Related reading in this series

• Article 02, Law 18-11 Articles 212 and 213: the definitional boundary of devices and IVDs — https://www.grzanglobal.com/algeria-medical-device-registration/law-18-11-article-212-213-device-ivd-definitions/
• Article 11, The standard homologation process: six stages from dossier submission to decision — https://www.grzanglobal.com/algeria-medical-device-registration/standard-homologation-process-six-stages/
• Article 35, 5-year validity and the 90-day renewal window: Articles 34 and 35 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/five-year-validity-90-day-renewal-window/

Regulatory information verified as of October 30, 2026.

GRZAN helps manufacturers determine the correct regulatory pathway in Algeria, prepare device or combination-product dossiers, and manage validity and renewal obligations across both the homologation and registration regimes. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.