Algeria Compliance Calendar for the Next 12 Months

1. Key takeaways

Laying the dates found in the verified official texts over the next 12 months, the most prominent item is the 2-year window of the order of 20 February 2025: counted from its publication on 25 February 2025, its end point falls in February 2027.

Next come the 5-year validity of homologation decisions plus the 90-day renewal window (Articles 34 and 35) and the requirement of actual marketing within 18 months of issuance (Article 37).

GRZAN’s recommendation: put these three groups of dates on a single calendar and let whichever node expires first drive the action. A calendar that shows only the farthest date creates false comfort; a calendar that ranks every node by proximity turns compliance from a scramble into a routine.

2. Legal basis

1. 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 (marketing authorised for 2 years, counted from publication) and Article 2 (publication).
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 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 34 (validity of 5 years), Article 35 (renewal to be requested at the latest 90 days before expiry) and Article 37 (withdrawal where not marketed within 18 months).
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 44 (transitional provision, amended by Executive Decree No. 23-101 to 2 years from 22 November 2022).
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 (Order of 10 May 2021 fixing the composition of the homologation dossier and the renewal dossier, JORADP No. 55, published on 14 July 2021, pages 21–24, 13 articles in total), Article 8 (the 90-day renewal lead time) and Article 10 (the 21 items of the renewal dossier).

3. Expert insights

Insight 1: the three groups of dates differ in nature and cannot be managed the same way.

February 2027 is an external window end point that expires simultaneously for all products on sale without a homologation decision. The 5-year validity is calculated per certificate, so every certificate differs. The 18-month node is a per-certificate activation deadline that arrives earlier than expiry. The calendar therefore has to be layered: one layer holds market-level nodes, the other holds certificate-level nodes. Mixing the two layers in a single undifferentiated list is the most common reason deadlines are missed.

Insight 2: the correct algorithm for certificate-level nodes is to take the earliest.

For a single certificate there are three key dates: 90 days before expiry (deadline for the renewal application), the expiry date itself (5 years), and 18 months after issuance (the activation node). The one that expires earliest is the one that drives action. Many companies see only the 5 years and overlook the much earlier pressure point of month 18 — and discover at renewal time that Article 37 has already been engaged.

Insight 3: the 22 November 2024 node has passed, and status judgements must adjust accordingly.

Executive Decree No. 23-101 set the regularisation deadline of Article 44 at 2 years from 22 November 2022, ending on 22 November 2024, which has now lapsed. This means the regularisation channel for products already on sale without a homologation decision is no longer in an open window; such products can now only go through ordinary homologation, or rely on the transitional marketing authorisation of the 2025 order.

Insight 4: the practical actions of the next 12 months split into three phases.

Phase 1 (immediate): map the SKUs on sale and build the list of products without a homologation decision. Phase 2 (within 3–6 months): rank by risk and sales volume and complete the first batch of filings. Phase 3 (continuous): manage renewals and activation nodes on the certificate calendar, and keep monitoring JORADP for any new amending order to Executive Decree No. 20-324.

4. Practical recommendations

1. Build a two-layer calendar — market level plus certificate level — with February 2027 on the market layer and per-certificate dates on the certificate layer.
2. Set certificate-level reminders on the take-the-earliest principle: renewal at 90 days, expiry at 5 years, activation at 18 months.
3. Complete the SKU mapping immediately and build the ranked list of products without a homologation decision.
4. Complete the first batch of filings within 3–6 months, prioritising high-risk and high-volume SKUs.
5. Set a zero-tolerance node for February 2027 and enter a sprint six months ahead.
6. Monitor JORADP continuously, focusing on amending orders to Executive Decree No. 20-324 and the journal texts of the three 2025 orders.

5. Verification checklist

• □ The two-layer calendar exists (market level plus certificate level).
• □ Certificate-level reminders follow the take-the-earliest principle.
• □ The SKU mapping is complete and the list of products without a homologation decision is ranked.
• □ The first filing plan is scheduled (within 3–6 months).
• □ The February 2027 zero-tolerance node and the 6-month sprint are set.
• □ The JORADP monitoring mechanism exists and covers both target text categories.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: building the compliance calendar, driving renewal and activation deadlines, managing transitional-window filings, and handling vigilance, recalls and inspection responses. For post-market compliance support in Algeria, contact info@grzanglobal.com.