Three Change Categories and 12-Month Deferred Reporting: Articles 3 and 4 of the 2021 Order

1. Key takeaways

Articles 3 and 4 of the order of 23 June 2021 establish a two-layer classification for changes to a homologation decision.

Article 3 classifies changes by content into three categories — administrative changes, technical changes, and changes affecting performance, safety, effectiveness and materiovigilance — and each category must be submitted as a separate application.

Article 4 classifies changes by level of risk into three grades: minor (mineure), moderate (modérée) and major (majeure).

Article 4, fourth paragraph, provides one important convenience: a minor change that does not affect the information recorded in the decision and requires no ongoing monitoring of the device may be submitted within 12 months after implementation.

2. Legal basis

1. 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 (Order of 23 June 2021 on the modalities of modification of the homologation decision for medical devices intended for human medicine, JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Article 3 (the three categories of changes and the separate-application rule) and Article 4 (the three risk grades, the 12-month deferred reporting of minor changes, and the fact that the classification characteristics and documents are set by the Director General of ANPP); Article 7 (dossier materials after the change) and Article 9 (reception within 8 days).
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 6 Rabie Ethani 1442 corresponding to 22 November 2020 on the modalities of homologation of medical devices, JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 36 (changes that must be declared immediately during the validity period).
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 33 (the decision must record nine items of information).
4. 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 (JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Article 2 (changes are subject to fees) and Article 2 (the change fee of 150.000 DA).

3. Expert insights

Insight 1: Articles 3 and 4 are two parallel classification dimensions.

Article 3 classifies by content (administrative / technical / performance-safety-effectiveness-vigilance) and determines that the applications must be filed separately. Article 4 classifies by risk (minor / moderate / major) and determines when to file and how much to pay. Every change must be placed on both dimensions at once — recording only one of them is incomplete and will cause trouble at the reception check.

Insight 2: the 12-month deferred reporting rule has two conditions, both of which must be met.

Article 4, fourth paragraph: a minor change that does not affect the information recorded in the homologation decision and that does not require ongoing monitoring of the device may be submitted within 12 months of implementation. Both conditions are indispensable. As soon as a change touches any one of the nine items of Article 33, the 12-month route is closed and the change must be declared in advance.

Insight 3: the detailed characteristics of the three grades are set by the Director General of ANPP.

Article 4, third paragraph: the characteristics, submission conditions and required documents for each grade are set by the Director General of ANPP. This means that beyond the order itself, companies must watch for ANPP decisions and guidance. GRZAN’s practice is to confirm the classification of the intended change with ANPP in writing before filing, so that the file cannot be rejected on classification grounds.

Insight 4: the reception review under Article 9 adds a change-classification check.

Article 9: the reception review of a change dossier (8 days) examines the change classification, the completeness and authenticity of the documents required for each category, and payment of the change redevance. Compared with the three checks of Article 22 of Executive Decree No. 20-324, the change channel adds classification as a fourth item — a wrong classification leads directly to non-reception.

Insight 5: Article 7 b) requires a list of minor changes implemented but not declared in the past 12 months.

Article 7, first paragraph, b): for a change that is a “minor change not requiring immediate declaration”, the application must describe all minor changes implemented and not yet declared within the past 12 months. This provision effectively gives companies one consolidated catch-up filing opportunity — use it deliberately rather than letting the list accumulate by accident.

4. Practical recommendations

1. Maintain a dual-dimension change register: every change is logged with both its content category and its risk grade.
2. Screen against the nine items of Article 33: any change affecting one of them goes through advance declaration, never the 12-month route.
3. Confirm the classification of the intended change with ANPP in writing before filing, and archive the written reply.
4. Use the consolidated catch-up mechanism of Article 7 b) to clear all minor changes implemented but not declared in the past 12 months at once.
5. File the three categories of changes separately, never merged; prepare each application in the format of Article 5.
6. Budget changes at 150.000 DA per application.

5. Verification checklist

• □ The dual-dimension change register exists (content category plus risk grade).
• □ Screening against the nine items of Article 33 has been performed; affected changes are declared in advance.
• □ Written ANPP confirmation of the classification has been obtained.
• □ The consolidated catch-up filing for minor changes of the past 12 months has been completed.
• □ The three categories have been filed separately, each in the Article 5 format.
• □ The change budget is built at 150.000 DA per application.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market, including change classification and filing under the 2021 change order, catch-up filing of minor changes, fee planning, and coordination with ANPP. For support with changes, recalls and inspection responses in Algeria, contact info@grzanglobal.com.