Nine Items Required on the Homologation Decision under Article 33

1. Key takeaways

Article 33 of Décret exécutif n° 20-324 enumerates the 9 items of information that the homologation decision must contain: the trade name, the product name, the classification, the characteristics, the name and address of the certificate holder, the name and address of the operator, the name and address of the manufacturer and its manufacturing site, the storage conditions and duration, and the certification body. This is not a formalistic requirement: Article 43 provides that transfer or assignment requires a new decision, and Article 36 requires that any change to the declared elements be declared without delay — every change ultimately lands on these 9 items.

For that reason the 9 items should be treated as the master data set of the whole project. Whoever controls the accuracy of these nine fields controls the correctness of every certificate, amendment and renewal that follows. Errors introduced at submission propagate through the entire life cycle of the decision and are far more expensive to correct later than to prevent at the start.

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 homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 33 (the decision must state the 9 items of information), Article 32 (the decision is issued only to the establishments referred to in Article 18), Article 36 (changes must be declared without delay), Article 43 (transfer or assignment requires a new decision).
2. 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 procedures for homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles in total): Article 13 (the decision for export-only devices must likewise state the 9 items of Article 33, with a note that the device is intended exclusively for export).
3. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their agrément, JORADP No. 14, published 28 February 2021, pages 9–12, 29 articles in total): Article 4 (the name and address of the holder and of the operator correspond to items 5 and 6 of Article 33).
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 (Ministerial Order of 23 June 2021 on the procedures for modification of the homologation decision for medical devices for human medicine, JORADP No. 62, published 15 August 2021, pages 21–22, 16 articles in total): Article 3 (changes affecting the information stated on the decision under Article 33 require a modification application).

3. Expert insights

Insight 1: Article 33 records holder, operator and manufacturer at the same time, making the decision the public carrier of the three-party relationship. Among the 9 items, item 5 is the name and address of the holder, item 6 the name and address of the operator, and item 7 the name and address of the manufacturer and its site. These three parties form the subject triangle of Algerian device compliance: the holder owns the decision, the operator executes the delegated operations, and the manufacturer produces the device. Any inconsistency between the three sets of registered data will surface during review and during post-market controls.

Insight 2: item 9, the certification body, is the item most easily overlooked. Article 33, ninth item, requires the decision to state the certification body (l’organisme de certification). This item designates the body that issued the product conformity certificate and corresponds to the requirement in Article 4 for a conformity certificate attesting compliance with regulatory standards. The body must therefore be identified before submission, and its certificate obtained, because the answer cannot be filled in afterwards once the decision is drafted.

Insight 3: Article 32 restricts who receives the decision, so a foreign holder never holds the original. Article 32 provides that the decision is issued only to the establishment referred to in Article 18, that is, the agréd pharmaceutical establishment in Algeria. The legal position of a foreign détenteur is therefore expressed by being named on the decision, not by holding the original document. In practice, a custody arrangement for the original and a mechanism for providing certified copies to the foreign holder must be set up in the cooperation agreement.

Insight 4: for export-only devices, the 9 items are supplemented by an export-only note. Article 13 of the Ministerial Order of 23 June 2021 provides that the decision for export-only devices must state the 9 items of Article 33 and must additionally note that the device is manufactured locally and intended exclusively for export. This note limits the use of the decision: if the device is later to be marketed domestically, a separate application is required. Teams should not assume that an export decision can quietly convert into a domestic one.

4. Practical recommendations

1. Before submission, complete a worksheet of the 9 items of Article 33 and ensure every item has a definitive value.
2. Use one single set of official registration data for the names and addresses of all three parties to avoid spelling discrepancies later.
3. Identify the certification body for item 9 before submission and obtain its conformity certificate.
4. After the decision is issued, verify the 9 items word by word; if an error is found, declare the correction immediately under Article 36.
5. Establish custody of the original decision and a mechanism for providing certified copies to the foreign holder.
6. For export-only devices, additionally verify that the export-only note appears on the decision.

5. Verification checklist

• □ The worksheet of the 9 items of Article 33 has been completed.
• □ The names and addresses of the three parties have been unified with official registration data.
• □ The certification body of item 9 has been identified and the conformity certificate obtained.
• □ The 9 items have been verified word by word after the decision was issued.
• □ Custody of the original and certified-copy provision are in place.
• □ The export-only note on export decisions has been checked.

Further reading in this series: Can a foreign manufacturer be the certificate holder: the dual-track design of détenteur and exploitant — https://www.grzanglobal.com/algeria-medical-device-registration/foreign-manufacturer-detenteur-exploitant/ ; Transfer and assignment: Article 43 of Executive Decree 20-324 requires a new certificate — https://www.grzanglobal.com/algeria-medical-device-registration/transfer-and-assignment-new-decision/ ; Packaging mock-ups and labelling: mandatory Arabic wording — https://www.grzanglobal.com/algeria-medical-device-registration/labelling-arabic-language-requirements/

Regulatory information verified as of 30 October 2026.

GRZAN supports medical device manufacturers entering Algeria with the appointment of a qualified local authorised representative and importer, verification of homologation decision contents against Article 33 of Executive Decree n° 20-324, and complete fee budgeting in Algerian dinars (DZD). For assistance with certificate data management or any question on this topic, contact info@grzanglobal.com.