Risk management and environmental assessment in the Algerian dossier

1. Key takeaways

Risk management lands in two places in the Algerian framework. The first is the third phase of the technical evaluation under Article 25 of Executive Decree No. 20-324, which is the assessment of the risk analysis report. The second is the environmental risk assessment required by items 7 and 11 of Article 4 of the Ministerial Order of 10 May 2021. The fourth sub-item of Part III under Article 5 then writes the risk evaluation (l’évaluation du risque) into Part III of the dossier itself.

The GRZAN reading is that Algeria requires a dual-dimension risk report covering product risk and environmental risk, not a straightforward reuse of an ISO 14971 file. An ISO 14971 report is the right skeleton, but it must be extended with the two locally specific chapters — environmental risk and waste disposal — and it must be written in a form that a reviewer can evaluate, with conclusions, acceptability judgements and a statement of residual risk.

The environmental dimension appears twice in the 22-item list, once as an assessment and once as precautionary information, which confirms that it is an independent requirement rather than an incidental mention.

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 N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 25 (the four phases of technical evaluation; the third phase is the assessment of the risk analysis report).
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, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (the environmental risk assessment; the potential environmental risks indicated within the precautions and safety instructions for storage, use and waste disposal),

and Article 5 (Part III includes the risk evaluation).

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, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 10 (the renewal dossier lists no separate risk item, but retains the environmental risk assessment requirement).
2. 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 regularisation dossier does not include the environmental risk assessment, but ANPP may require its completion).

3. Expert insights

Insight one: environmental risk appears twice in the 22-item list, making it an explicit standalone requirement.

Item 7 of Article 4 requires the evaluation of the risks that the device may pose to the environment, where applicable. Item 11 requires the precautions and safety instructions for storage, use and waste disposal, together with an indication of the potential risks of the device to the environment. Together, these two references constitute a complete environmental risk file: the assessment plus the control information. Preparing only one of the two halves leaves a visible gap, because a reviewer checking the list item by item will find the missing twin reference immediately.

Insight two: the third phase of technical evaluation uses the phrase risk analysis report, a wording broader than ISO 14971.

The original wording of the third phase under Article 25 is l’évaluation du rapport d’analyse des risques — the assessment of the risk analysis report. What is required is a report that can be reviewed, not an internal risk worksheet. GRZAN recommends writing the report following the structure of ISO 14971, then adding the two locally specific chapters on environmental risk and waste disposal. A report with hazards, harms, severity and probability scales, acceptability criteria and residual-risk conclusions reads as reviewable; a bare risk table with no narrative does not.

Insight three: the 19-item regularisation dossier omits the environmental risk assessment, and that is a point worth negotiating carefully.

Comparing the 22-item and 19-item lists, the regularisation dossier drops the environmental risk assessment, the description of the manufacturing method (now where applicable) and the quality control methods (now where applicable). However, the second paragraph of Article 4 of the regularisation order gives the Director General of ANPP the power to require completion. Applicants using the regularisation channel should therefore keep the environmental risk documentation ready as a standby annex, absent from the master list but available on demand. Treating the omission as a permanent exemption is the error to avoid.

Insight four: environmental risk overlaps with the second phase of technical evaluation, the physicochemical and biological testing.

The assessment of physicochemical and biological testing touches materials, leachables and waste characteristics, so it shares data with the environmental risk assessment. The GRZAN method is to build a shared data table so that both documents cite the same underlying records, avoiding data conflicts between the two files. When the same leachable value appears with two different numbers in two chapters, the reviewer’s confidence in the entire dossier drops, and the correction cycle is far more expensive than maintaining one source of truth from the outset.

4. Practical recommendations

1. Write the risk management report following the ISO 14971 structure, adding the environmental risk and waste disposal chapters.
2. Make the environmental risk file satisfy both item 7, the assessment, and item 11, the precautionary and safety information.
3. Build a shared source-data reference table with the physicochemical and biological testing file to avoid data conflicts.
4. On the regularisation channel, keep the environmental risk documentation as a standby annex, ready to be supplied.
5. Write the report in a reviewable form: with conclusions, acceptability judgements and a statement of residual risk.
6. Update the risk management report at renewal to reflect real-world use data gathered since the approval.

5. Verification checklist

• □ The risk management report follows the ISO 14971 structure with the two added chapters.
• □ The environmental risk file satisfies both the assessment and the precautionary-information requirements.
• □ The shared data reference table with the physicochemical and biological testing has been established.
• □ The standby environmental risk annex for the regularisation channel is complete.
• □ The report contains conclusions, acceptability judgements and residual-risk statements.
• □ The risk management report for renewal has been updated.

• Article 13 — The four phases of technical evaluation: Article 25 of Executive Decree No. 20-324: https://www.grzanglobal.com/algeria-medical-device-registration/article-25-technical-evaluation-four-phases/
• Article 22 — The 22-item initial homologation dossier, item by item: https://www.grzanglobal.com/algeria-medical-device-registration/initial-dossier-22-items-breakdown/
• 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/

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 dual-dimension risk reporting and environmental risk assessment drafting. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.