The 21-item renewal dossier and its consolidated two-part format

1. Key takeaways

The rules on renewal (renouvellement) are concentrated in Articles 8 to 12 of the Ministerial Order of 10 May 2021: the application must be filed by the holder and/or the operator, no later than 90 days before the expiry of the decision (Article 8); it is submitted by the technical director pharmacist (Article 9); the dossier contains 21 items (Article 10); it is filed in the consolidated 2-part format under Annex III (Article 11); and ANPP may initiate quality control on the basis of the technical evaluation conclusions (Article 12).

Compared with the first dossier, the renewal dossier adds the summary of the materiovigilance system and the benefit-risk assessment, plus a chronological detail of modifications submitted or under review since the approval. These are post-market contents: they can only be produced if the systems were actually running during the validity period, which makes renewal preparation a five-year project rather than a three-month sprint.

The practical estimate applied by GRZAN is to start renewal preparation six months before expiry, so that the 90-day window is approached with every post-market document already assembled.

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 8 (the 90-day lead time); Article 9 (submission by the technical director pharmacist); Article 10 (the 21 items),

Article 11 (the consolidated 2-part format with Annex III, and the possibility for ANPP to require the full 5-part dossier); Article 12 (quality control).

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 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 35 (the renewal application must be filed no later than 90 days before expiry); Article 34 (a 5-year period of validity).
2. 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 2 (renewal requires payment of the fee, with the payment receipt attached).
3. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of 30 December 2021, JORADP N° 02, published 2022-01-05, pages 14–15): Article 2 (renewal fee rate 300.000 DA).

3. Expert insights

Insight one: the 90-day lead time is written in both texts, and it is a hard deadline.

Article 35 of Executive Decree No. 20-324 and Article 8 of the Ministerial Order of 10 May 2021 both state that the renewal application must be filed no later than 90 days before expiry. The repetition signals that the legislator deliberately emphasised this node. The current text provides no grace period once the 90-day window is missed, so a late filing leaves the holder exposed: the decision approaches expiry with no renewal pending, and the pending verification of how the agency treats a lapsed file offers no comfort. Calendar management, not paperwork speed, is what protects the 90-day deadline.

Insight two: the renewal dossier adds two post-market contents that the first dossier does not have.

Comparing the 22-item and 21-item lists, the renewal additions are the résumé du système de matériovigilance — the summary of the materiovigilance system — and the évaluation du rapport bénéfice/risque, the benefit-risk assessment of the device in Algeria and in the country of origin, together with the chronological detail of modifications submitted or under review since approval. All of these are contents that can only arise after the product is on the market and cannot be produced retroactively. A holder with no functioning materiovigilance system cannot conjure a credible summary in the final weeks before filing.

Insight three: the renewal dossier is a consolidated version filed in 2 parts, but the full 5 parts may be demanded.

Article 11 requires submission under Annex III as a consolidated version containing all changes since the decision was issued, divided into Part I (administrative data) and Part II (technical, performance, non-clinical and clinical summaries). The closing paragraph of the same article adds that ANPP may require the complete 5-part dossier under Article 5. In practice both sets must be prepared and kept ready: the consolidated version is the filing format, and the full 5-part dossier is the contingency that must be producible without a rebuild.

Insight four: renewal reviews maintenance, not the product anew.

Article 10 repeatedly uses the language of maintenance: the CLV must prove the maintenance of registration and marketing; the country-of-origin marketing authorisation must be the renewed version; the parties must remain authorised for the approved and/or declared activities. The review focus is whether every status has remained continuously valid, not a re-evaluation of the product itself. This reframes renewal work as an audit of continuity — of certificates, licences and vigilance records — rather than a rewrite of the technical file.

4. Practical recommendations

1. Start renewal preparation 6 months before the expiry of the decision, leaving buffer before the 90-day window.
2. Establish the materiovigilance system early and accumulate data so that the system summary can be issued.
3. Prepare the benefit-risk assessment report for the device in Algeria and in the country of origin.
4. Compile the chronological detail of all modifications since approval, including those still under review.
5. Prepare both the 2-part consolidated version and the full 5-part dossier.
6. Pay the renewal fee under Article 2 and attach the payment receipt to the dossier.

5. Verification checklist

• □ Renewal preparation started 6 months before expiry.
• □ The summary of the materiovigilance system can be issued.
• □ The benefit-risk assessment for Algeria and the country of origin is complete.
• □ The chronological detail of post-approval modifications is compiled.
• □ Both the 2-part consolidated version and the 5-part full dossier are ready.
• □ The renewal fee has been paid and the receipt is attached to the dossier.

• Article 35 — The 5-year validity and the 90-day renewal window: Articles 34 and 35 of Executive Decree No. 20-324: https://www.grzanglobal.com/algeria-medical-device-registration/five-year-validity-90-day-renewal-window/
• Article 46 — On whom do the materiovigilance obligations fall: https://www.grzanglobal.com/algeria-medical-device-registration/materiovigilance-obligations-who-is-responsible/
• Article 38 — Fee anchors: 150,000 dinars for modification, 300,000 for renewal, 100,000 for transfer: https://www.grzanglobal.com/algeria-medical-device-registration/fee-anchors-modification-renewal-transfer/

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 renewal planning, materiovigilance summaries and consolidated-format assembly. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.