The 22-item initial homologation dossier of Algeria, item by item

1. Key takeaways

Article 4 of the Ministerial Order of 10 May 2021 sets out the 22-item list of the initial homologation dossier. The list covers identity information, product description, manufacturing and testing, trials and performance, packaging mock-ups, foreign-country evidence, conformity certificates, the price structure and the special-category designations. It is the master list for any Algerian device dossier, and it is the direct yardstick against which the acceptance review decides whether the dossier is complete.

The timelines attached to that review are short. Under Article 22 of Executive Decree No. 20-324 the acceptance check runs for 8 days, and under the regularisation track the window is measured in single-digit days as well. A single missing item within the 22 can therefore push the file into the regularisation procedure instead of technical evaluation, with all the delay that implies.

The practical estimate applied by GRZAN is that the 22-item list should be treated as a project plan: every item gets an owner, a status and a page reference in the dossier, so that completeness can be demonstrated item by item on the day of submission, not reconstructed afterwards.

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 4 (the 22-item list); Article 5 (the 5-part format); Article 2 (payment of fees and the payment receipt).
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 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 22 (the 8-day acceptance review and refusal of non-compliant files); Article 21 (payment of fees and receipt).
3. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant les modalités de régularisation du dossier d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the modalities for regularising the homologation dossier for medical devices, JORADP N° 55, published 2021-07-14, pages 24–26, 14 articles in total): Article 6 (the 19-item regularisation dossier).
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 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 7 (samples, raw materials, reagents and specific means).

3. Expert insights

Insight one: the very first item of the list names the technical director pharmacist.

The first item of Article 4 requires the name or trade name and the registered address of the applying establishment, the name and details of the technical director pharmacist, and, where applicable, the details of the manufacturer. This echoes Article 3 of the companion framework, under which the dossier is submitted by the technical director pharmacist. The structural message is that the dossier must allow the reviewer to locate both the establishment and the responsible individual at a glance. A file where the pharmacist details and the establishment details do not correspond creates an immediate identity problem that the acceptance reviewer is entitled to flag.

Insight two: the environmental risk assessment appears twice, and that repetition is a hidden priority.

Item 7 of Article 4 requires the evaluation of the risks that the device may pose to the environment, where applicable. Item 11, dealing with precautions and safety instructions for storage, use and waste disposal, again requires the potential risks of the device to the environment to be indicated. Two mentions within one list is not accidental. The GRZAN practice is to prepare a standalone environmental risk assessment chapter that answers both items, so that the reviewer never has grounds to conclude that one of the two references was overlooked.

Insight three: the foreign evidence consists of four items, and their wording differs.

Article 4 contains four distinct foreign-country requirements: the certificate of free sale (CLV), or a document issued by the pharmaceutical regulatory authority or any other recognised authority certifying that the device is registered and marketed in the country of origin; the marketing authorisation in the country of origin and the CPP, where applicable; copies of all marketing authorisations obtained in other countries; and the certificate of conformity with the regulatory standards. Note the breadth of the CLV wording: the fallback to “any other recognised authority” makes the evidence pool wider than in jurisdictions that only accept a single national certificate.

Insight four: the manufacturing and trial compliance certificate points to BPF / BPL / BPC.

Article 4 requires a document attesting that all parties involved in the manufacture of the finished product and, where applicable, in clinical trials, in particular their compliance with good manufacturing practice, ISO standards, good laboratory practice and good clinical practice (BPF/BPL/BPC), are authorised in their country to carry out the activities declared in the dossier. The target of this evidence is the qualification of the parties, not the certification of the product itself. Companies frequently submit a product certificate here and leave the party-level authorisations uncovered.

Insight five: the final item is the designation of four special device categories, and it shapes the review path.

The last item requires the dossier to indicate whether the device is one of the following: devices containing medicinal substances, blood or blood-derived components, components of animal origin, or latex and phthalates; active implantable devices; in vitro diagnostic devices; custom-made devices. These designations directly influence the depth of the technical evaluation and whether additional data will be requested, so they belong in a prominent position on the dossier cover page rather than buried in an annex.

4. Practical recommendations

1. Build a checklist from the 22 items of Article 4, recording an owner, a status and a document page number for every item.
2. Prepare the environmental risk assessment as a standalone chapter that answers both item 7 and item 11.
3. Start the CLV early; if the country of origin has no free-sale certificate system, use the alternative document from any other recognised authority and state the basis of substitution.
4. Request the BPF/BPL/BPC qualification evidence from each manufacturing and trial party individually; do not rely on the manufacturer’s documents alone.
5. State the four special-category designations prominently on the dossier cover page so reviewers can locate them immediately.
6. Prepare the price structure (where applicable) separately; this is an Algeria-specific submission item with no equivalent in many other markets.

5. Verification checklist

• □ The 22-item checklist is complete, with an owner, a status and a page number per item.
• □ The environmental risk assessment is a standalone chapter answering both requirements.
• □ The CLV or the substitute document is ready, with the basis of substitution explained.
• □ BPF/BPL/BPC evidence has been obtained from each manufacturing and trial party.
• □ The four special-category designations appear on the dossier cover page.
• □ The price structure documentation has been prepared separately.

• Article 21 — The five parts of the homologation dossier: Article 5 of the Ministerial Order of 10 May 2021: https://www.grzanglobal.com/algeria-medical-device-registration/dossier-five-parts-article-5/
• Article 23 — CLV, CPP and country-of-origin marketing authorisation: how to combine the three foreign evidence items: https://www.grzanglobal.com/algeria-medical-device-registration/clv-cpp-country-of-origin-authorisations/
• Article 24 — BPF, BPL, BPC and ISO: compliance evidence for manufacturing and trial activities: https://www.grzanglobal.com/algeria-medical-device-registration/bpf-bpl-bpc-iso-compliance-evidence/

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 22-item completeness mapping, CLV strategy and special-category designation review. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.