Samples, reagents and ANPP quality control submissions explained

1. Key takeaways

Technical evaluation in Algeria includes a laboratory testing component. Under Article 7 of the Ministerial Order of 10 May 2021, the applying establishment must, at the request of ANPP, submit the device, and where applicable the raw materials, intermediates or other components, the reagents and the specific means, together with the documents needed for the quality control of the finished product; ANPP notifies the quantities to be submitted, in order to verify that the formulation possesses the composition, performance and characteristics declared in the dossier. The fee side is governed by Article 2 of Executive Decree No. 21-552.

Three features define this obligation. First, it is triggered by a request, not discharged at filing. Second, the scope of submission is much wider than the finished product alone, extending to raw materials, intermediates, reagents and the specific means needed for testing. Third, renewal and modification each have their own sampling provisions, so the duty follows the dossier across its whole lifecycle.

The practical estimate applied by GRZAN for budgeting is built on the three tax tiers of Article 2 of Executive Decree No. 21-552, which must be kept distinct because they use different charging units.

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 7 (submission of samples, raw materials, intermediates, reagents and specific means at the request of ANPP; ANPP notifies the quantities).
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 12 (at renewal, ANPP may initiate quality control and/or performance qualification on the basis of the technical evaluation conclusions, with samples submitted per Article 7).
3. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 23 June 2021 on the modalities for modifying the homologation decision for medical devices, JORADP N° 62, published 2021-08-15, pages 21–22, 16 articles in total): Article 8 (the modification dossier must include the device, raw materials, intermediates, reagents and specific means); Article 11 (samples for the regularisation dossier).
4. Décret exécutif n° 21-552 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités d’acquittement et d’affectation du produit de la taxe de contrôle et expertise de lot de produit pharmaceutique et/ou de dispositif médical (Executive Decree No. 21-552 of 30 December 2021, JORADP N° 02, published 2022-01-05, pages 15–16): Article 2 (device batch control tax 30.000 DA; device testing for homologation, modification and renewal 60.000 DA; device raw material testing 24.000 DA).

3. Expert insights

Insight one: sampling is triggered on request, not delivered once at filing.

The wording of Article 7 is à la demande de l’agence — at the request of the agency. Samples are therefore not among the 22 items of the dossier; they are a duty of cooperation during evaluation. Once the sampling notice arrives, the quantities notified by ANPP must be assembled within the specified time, otherwise the timelines of Article 30 are affected. Teams should treat the notice as a project milestone with a named owner, because shipping laboratory samples, especially from abroad, rarely happens in days without preparation.

Insight two: the scope of submission is much wider than the finished product.

Article 7 enumerates the device itself, and where applicable the raw materials, intermediates or other components, the reagents, and the les moyens spécifiques nécessaires — the specific means necessary. The specific means include dedicated tools, calibration pieces and accompanying software, which is especially important for equipment-type products. An analyser without its calibrators and control software cannot be tested; a benchtop device without its dedicated fixtures cannot be verified. The sampling plan should therefore be drafted per product family at project start, long before any notice arrives.

Insight three: renewal and modification also trigger sampling, each under its own article.

For renewal, Article 12 provides that ANPP may initiate quality control and/or performance qualification on the basis of the technical evaluation conclusions, with samples submitted under Article 7. For modification, Article 8 of the Ministerial Order of 23 June 2021 requires the modification dossier to include directly the device, raw materials, reagents and specific means, with quantities notified by ANPP under the second paragraph of Article 7. In other words, in the modification channel the samples travel with the dossier, whereas in the initial and renewal channels they follow a request. The two logistics must not be confused.

Insight four: the three tiers of the control tax must be matched to the right object.

Under Article 2 of Executive Decree No. 21-552, the three device tiers are: 30.000 DA for the control and expertise of each batch of devices; 60.000 DA for device testing and expertise involved in homologation, modification and/or renewal; and 24.000 DA for device raw material testing. Note that the 60.000 DA tier is charged per product, while the 30.000 DA tier is charged per batch — the charging units differ, and the two must not be merged in a budget. A high-volume product therefore pays the batch tier repeatedly across production, while the homologation-tier fee is a one-off per procedure.

4. Practical recommendations

1. Start assembling samples on the day the sampling notice arrives, in the exact quantities notified by ANPP.
2. Cover all five categories in the sampling list: the device, raw materials, intermediates, reagents and specific means.
3. For equipment-type products, prepare the dedicated tools, calibration pieces and accompanying software in advance.
4. In the modification channel, submit the samples with the dossier under Article 8; do not wait for a separate notice.
5. Budget on three separate tiers: 30.000 DA per batch, 60.000 DA per homologation, modification or renewal procedure, and 24.000 DA per raw material.
6. Ship the samples with complete accompanying documents, including batch release records and self-inspection reports.

5. Verification checklist

• □ Sample assembly started the day the notice arrived, with quantities per the ANPP notification.
• □ The sampling list covers all five categories.
• □ The dedicated tools and accompanying software for equipment-type products are ready.
• □ In the modification channel, samples were submitted with the dossier under Article 8.
• □ The control tax has been budgeted across the three tiers separately.
• □ Batch release records and self-inspection reports accompany the samples.

• 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 39 — The batch control tax: what the 30,000, 60,000 and 24,000 dinar amounts correspond to: https://www.grzanglobal.com/algeria-medical-device-registration/batch-control-tax-dmd-amounts/
• Article 30 — The 21-item renewal dossier and the two formats: the consolidated version rule of Article 11: https://www.grzanglobal.com/algeria-medical-device-registration/renewal-dossier-21-items-consolidated-format/

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 ANPP sampling logistics and control tax budgeting. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.