Article 22 Admissibility Review in Eight Days: What ANPP Checks

1. Key takeaways

Article 22 of Décret exécutif n° 20-324 gives the ANPP no more than 8 days for the admissibility review. The review covers three items: the completeness of the dossier, the authenticity of the documents, and whether the homologation fee has been paid. If the dossier is incomplete, the application is declared irrecevable and the applicant is notified.

GRZAN’s reading is blunt: these 8 days are the highest-leverage 8 days of the whole project. Everything prepared before submission determines whether the application enters technical evaluation at all, and everything done afterwards consists of responding to additional-information requests and waiting. An application that survives the admissibility review cleanly has already avoided the most common and most expensive failure mode in the Algerian procedure.

The practical consequence is that the admissibility review should be treated as a gate to be engineered, not a formality to be observed. The 22-item checklist of Article 4, the five-part format of Article 5 and the legalisation of foreign documents are all judged, in effect, within these 8 days.

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 the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 22 (the 8-day admissibility review, its three subjects of review, and inadmissibility) and Article 21 (payment of the fee and issuance of the récépissé).
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 fixing the composition of the homologation dossier and the renewal dossier for medical devices intended for human medicine, JORADP No. 55, published 14 July 2021, pages 21–24, 13 articles): Article 4 (22 items for the first application dossier), Article 5 (the five-part format) and Article 10 (21 items for the renewal dossier).
3. 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 homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles): Article 6 (the 8-day admissibility review, checking positioning and classification as well as completeness).

3. Expert insights

Insight 1: because authenticity is written into the review, the legalisation and translation chain must be finished before submission.

Among the three subjects of the Article 22 review, the authenticity of documents (l’authenticité des documents) follows completeness. Certificates issued abroad, such as the CLV, the CPP and ISO certificates, must complete legalisation and translation before they are filed, otherwise the application will be stopped at this gate. GRZAN’s standard practice is to schedule completion of legalisation and translation at least 1 month before the intended submission date, leaving margin for embassy queues and sworn-translation lead times.

Insight 2: inadmissibility is a restart, not a correction opportunity.

The wording of Article 22 is that an incomplete dossier is declared irrecevable and the applicant notified. Compare Article 9 of the Ministerial Order of 23 June 2021 on modification of the homologation decision, which uses the same term, irrecevable: this is a procedural rejection, not a one-time offer to fix defects. Once declared inadmissible, the applicant must resubmit, pay the fee again and let the deadlines start running again from the beginning.

Insight 3: the standard channel allows 8 days and the regularisation channel only 4, but the review standard is the same.

Article 7 of the Ministerial Order of 10 May 2021 on regularisation sets the admissibility review period at 4 days and states expressly that it is carried out in accordance with Article 22 of Executive Decree No. 20-324. In other words, the content of the review is identical and only the time is halved. A regularisation application therefore needs to be even better prepared, because there is less room to absorb any defect discovered at the front desk.

Insight 4: for export-only devices the review carries one extra subject, positioning.

Article 6 of the Ministerial Order of 23 June 2021 on export-only devices lists the admissibility review as checking the positioning and classification of the device, the completeness of the dossier, the authenticity of the documents, and payment of the homologation fee. The extra item, positioning, means confirming that the device really is locally manufactured and intended exclusively for export, which is precisely the condition that justifies the separate pathway.

4. Practical recommendations

1. Before submission, run one complete check against the 22-item list of Article 4, with each item individually signed off.
2. Complete legalisation and sworn translation of all documents issued abroad at least 1 month before submission.
3. Assemble the dossier in the five-part format of Article 5, with numbering strictly following Annex II, to avoid format-related gaps.
4. File the proof of fee payment with the dossier, request the récépissé on the spot and verify its date.
5. On the regularisation channel, prepare to the 4-day standard; the shorter deadline never justifies lower completeness.
6. For export-only devices, prepare the declaration that the device is intended exclusively for export, matching the positioning check.

5. Verification checklist

• □ The pre-submission check against the 22-item list of Article 4 has been completed and signed.
• □ Legalisation and translation of documents issued abroad have been completed.
• □ The dossier has been assembled in the five-part format and numbering of Annex II.
• □ The proof of fee payment has been filed with the dossier and the récépissé date verified.
• □ The regularisation application has been prepared to the 4-day standard.
• □ The export-only declaration has been prepared for export-only devices.

GRZAN helps manufacturers pass the Algerian admissibility review on the first attempt, with pre-submission completeness audits, legalisation and translation planning, and classification strategy aligned with Executive Decree No. 20-324 and the orders of 10 May and 23 June 2021. Whether your application follows the standard 8-day review or the 4-day regularisation track, GRZAN can structure the dossier to match what the ANPP actually checks. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.