Five-Year Validity and the 90-Day Renewal Window

1. Key takeaways

Article 34 of Décret exécutif n° 20-324 provides that the homologation decision is valid for 5 years from the date of its signature; Article 35 provides that the renewal application must be submitted no later than 90 days before expiry. Article 8 of the Ministerial Order of 10 May 2021 repeats the 90-day requirement, and Article 2 of Executive Decree n° 21-551 sets the renewal fee at 300.000 DA. The calendar-management principle applied by GRZAN: count backwards from the signature date, not the date of receipt of the certificate, and start preparation 6 months before expiry.

These two articles, together with the fee rate, define the renewal rhythm of every certificate in an Algerian device portfolio. A portfolio that manages renewal dates from the wrong starting point will systematically drift toward late filings, and because the 90-day rule is written twice in the legislation with no grace mechanism, a missed deadline cannot be repaired administratively.

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 22 November 2020 on the procedures for homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 34 (valid for 5 years from the date of signature), Article 35 (renewal no later than 90 days before expiry).
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 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices for human medicine, JORADP No. 55, published 14 July 2021, pages 21–24, 13 articles in total): Article 8 (90-day lead time), Article 9 (submission by the pharmacien directeur technique), Article 10 (21 items), Article 11 (consolidated format).
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 on the collection and allocation of the redevance on pharmaceutical products and medical devices, JORADP No. 02, published 5 January 2022, pages 14–15): Article 2 (renewal 300.000 DA, modification 150.000 DA, transfer 100.000 DA).
4. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités d’homologation des dispositifs médicaux fabriqués localement et destinés exclusivement à l’exportation (Ministerial Order of 23 June 2021 on the procedures for homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles in total): Article 14 (export-only decisions likewise valid for 5 years), Article 15 (renewal in accordance with Article 35).

3. Expert insights

Insight 1: the starting point is the date of signature, not the date of receipt or of publication. The wording of Article 34 is validity à compter de la date de sa signature, from the date of its signature. A company that begins counting only when the certificate physically arrives will start late. The correct practice is to obtain the signature date and open a file immediately. If the certificate does not print the signature date, a written enquiry to the ANPP should be made to confirm it, and the reply kept on record as the basis of the calendar.

Insight 2: the 90-day rule appears twice, which is deliberate legislative emphasis. Article 35 of Executive Decree No. 20-324 and Article 8 of the Ministerial Order of 2021 both state the requirement of submission no later than 90 days before expiry. This repetition means it is not an administrative practice that can be relaxed at discretion, and the current texts contain no grace provision for late filings. Renewal is therefore a hard deadline: the dossier and the fee must be ready before the 90-day window opens, not during it.

Insight 3: the 5-year validity and renewal rules for export-only devices are fully aligned with Articles 34 and 35. Article 14 of the Ministerial Order of 23 June 2021 provides that decisions for export-only devices are valid for 5 years from the date of signature; Article 15 provides that renewal follows Article 35 of Executive Decree No. 20-324. The channels are therefore identical on validity and renewal; only the time limits of the decision process differ. There is no reason to maintain a separate calendar logic for export-only certificates.

Insight 4: the renewal fee of 300.000 DA is the highest of the three device fee tiers. Article 2 of Executive Decree No. 21-551 sets device modification at 150.000 DA, renewal at 300.000 DA, and transfer at 100.000 DA. Renewal sits in the same tier as the establishment expert-review fee (300.000 DA) and the clinical trial authorisation and certification fees (300.000 DA each). Budget owners should treat renewal as a major recurring line item, not a routine administrative cost, and plan cash flow around it.

4. Practical recommendations

1. Maintain a certificate register with fields for signature date, expiry date, renewal filing deadline (90 days before expiry) and internal start date (6 months before expiry).
2. Set two-level reminders: start preparation 6 months before expiry, complete submission 4 months before expiry.
3. If the certificate does not print the signature date, enquire to the ANPP immediately and keep the confirmation on file.
4. Prepare the renewal dossier according to the 21 items of Article 10, with the complete 5-part file.
5. Budget the renewal at 300.000 DA and add the control tax of Executive Decree n° 21-552.
6. Manage export-only devices under the same calendar rules; do not maintain a separate calendar.

5. Verification checklist

• □ A certificate register is in place with signature and expiry date fields.
• □ Two-level reminders are set (6 months start, 4 months submission).
• □ Certificates without a printed signature date have been confirmed with the ANPP.
• □ The renewal dossier is prepared with the 21 items and the complete file.
• □ The renewal budget includes 300.000 DA and the control tax.
• □ Export-only devices are covered by the same calendar.

Further reading in this series: The 21 items of the renewal dossier and the two formats: the consolidated format rule of Article 11 — https://www.grzanglobal.com/algeria-medical-device-registration/renewal-dossier-21-items-consolidated-format/ ; Fee anchors: modification 150,000, renewal 300,000, transfer 100,000 dinars — https://www.grzanglobal.com/algeria-medical-device-registration/fee-anchors-modification-renewal-transfer/ ; Withdrawal after 18 months without actual marketing: Article 37 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/withdrawal-after-18-months-no-marketing/

Regulatory information verified as of 30 October 2026.

GRZAN supports medical device manufacturers entering Algeria with the appointment of a qualified local authorised representative and importer, renewal calendar management under Articles 34 and 35 of Executive Decree n° 20-324, and complete fee budgeting in Algerian dinars (DZD). For assistance with renewal planning or any question on this topic, contact info@grzanglobal.com.