Who Regulates Medical Devices in Algeria

1. Key takeaways

Market approval for medical devices in Algeria is handled by two separate authorities: the National Agency of Pharmaceutical Products (ANPP) and the Ministry of Pharmaceutical Industry. Neither can substitute for the other, and both must be satisfied before a product can form a lawful chain from authorization to market.

Under Article 230 of Loi n° 18-11, every ready-to-use, industrially manufactured device must obtain, before being placed on the market, a homologation decision (décision d’homologation) issued by the body established under Article 223 of the same law, namely the ANPP.

However, the agrément for the pharmaceutical establishment that receives and holds that decision is granted, under Article 218 of Loi 18-11 together with Article 3 of Décret exécutif n° 21-82, by the Minister of Pharmaceutical Industry.

GRZAN’s practical reading of this split is straightforward: on the product side, watch the ANPP; on the corporate side, watch the Ministry of Pharmaceutical Industry. The two tracks must be advanced in parallel. If either track stalls, the product cannot be lawfully marketed in Algeria, no matter how complete the technical dossier is.

This dual-track design is the single most important structural feature of the Algerian system. Many foreign manufacturers discover it late, after technical evaluation is finished, when they realize that the entity named on the homologation decision still lacks a valid establishment license. Understanding it at project start avoids months of delay.

2. Legal basis

1. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 18 Chaoual 1439 corresponding to July 2, 2018 on health, JORADP No. 46, published 2018-07-29), Article 223 (establishment of the National Agency of Pharmaceutical Products) and Article 230 (registration or homologation decision required before placing on the market).
2. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 18 Chaoual 1439 corresponding to July 2, 2018 on health, JORADP No. 46, published 2018-07-29), Article 218 (pharmaceutical establishments require a license and technical direction by a pharmacien directeur technique) and Article 219 (five categories of pharmaceutical establishments).
3. Décret exécutif n° 19-190 du 30 Chaoual 1440 correspondant au 3 juillet 2019 fixant les missions, l’organisation et le fonctionnement de l’agence nationale des produits pharmaceutiques (Executive Decree No. 19-190 of 30 Chaoual 1440 corresponding to July 3, 2019 fixing the missions, organization and functioning of the national agency of pharmaceutical products, as amended by Decree No. 20-391 of 2020-12-19 and supplemented by Decree No. 21-525 of 2021-12-26) — missions, organization and operation of the ANPP.
4. 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 11 Rajab 1442 corresponding to February 23, 2021 on pharmaceutical establishments and the conditions of their agrément, JORADP No. 14, published 2021-02-28, pages 9–12, 29 articles), Article 3 (establishments are licensed by the Minister of Pharmaceutical Industry) and Article 9 (duties of exploitation establishments).

3. Expert insights

Insight one: the ANPP is the technical review and certification body, not the overall regulator.

Article 230 of Loi 18-11 says the decision is issued by the national agency of pharmaceutical products referred to in Article 223, on the basis of the opinion of the registration and homologation commission. In other words, the ANPP’s statutory role is to receive dossiers, conduct technical evaluation, organize the commission and issue certificates. Whether a company may act as a licensed establishment, and whether it may import, depends on the Ministry of Pharmaceutical Industry. GRZAN typically runs the two tracks in parallel so that corporate licensing is never discovered missing at the end of technical evaluation.

Insight two: the Ministry of Health was not written as the licensing authority.

The original wording of Article 218, drafted in 2018, said pharmaceutical establishments require a license from the competent department of the Ministry of Health. By 2021, Article 3 of Décret exécutif n° 21-82 had made the Minister of Pharmaceutical Industry the licensing authority. A transfer of functions took place in between. GRZAN notes that some older secondary materials still repeat the outdated reading that the Ministry of Health issues licenses; this no longer matches the current text, and the Ministry of Pharmaceutical Industry should be treated as the correct reference.

Insight three: the import license and the product approval are two different matters.

The ANPP only issues product homologation decisions. The qualification to import, that is, the status of an import pharmaceutical establishment, is defined in Article 10 of Décret exécutif n° 21-82 and granted by the Ministry of Pharmaceutical Industry under the licensing procedures of Articles 19 to 23. Companies frequently equate holding the homologation certificate with being able to clear customs. In reality, a valid import establishment license in force is also required, and customs control verifies the establishment side, not only the product side.

Insight four: the two tracks interact through timing, not hierarchy.

The homologation decision and the agrément are independent legal acts, but each one references the other: the decision records the establishment, and the establishment must be licensed to act on the decision. Planning the two clocks together, rather than sequentially, is what keeps the total time to market short.

4. Practical recommendations

1. At project start, open both tracks at once: prepare the homologation dossier on the product side, and verify on the corporate side whether the local partner already holds an agrément issued by the Ministry of Pharmaceutical Industry.
2. Check whether the activities recorded on the partner’s agrément include importation or exploitation; an establishment holding only a production license cannot perform the import function.
3. Confirm that the partner’s pharmacien directeur technique is in post; Article 14 of Décret exécutif n° 21-82 requires each establishment to have at least one pharmacien directeur technique and one assistant pharmacist.
4. State in the agreements who acts as détenteur (holder) and who acts as exploitant (operator); these two roles recur in every subsequent filing.
5. Establish a formal written communication channel with the ANPP, and rely exclusively on written notices for requests for additional documents, fee payments and sample submissions, never on oral assurances.
6. Manage the validity period of the Ministry license and the validity period of the ANPP homologation decision on a single combined timeline, so that the expiry of one does not drag down the other.

5. Verification checklist

• □ The local partner holds or has been confirmed to hold an agrément issued by the Ministry of Pharmaceutical Industry, covering importation or exploitation activities.
• □ The agrément is within its validity period and does not fall under the lapse rule for two years of inactivity in Article 23 of Décret exécutif n° 21-82.
• □ The partner has a pharmacien directeur technique in post.
• □ The agreements define the division between détenteur and exploitant and the arrangements for joint liability.
• □ A filing system exists for ANPP correspondence and payment receipts.
• □ The latest wording of Articles 223 and 230 of Loi 18-11 on the issuing authority has been checked, and no outdated reading is in use.

Related reading in this series

• Article 07, Who can submit the application: the entity threshold of Article 18 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/who-can-submit-homologation-application/
• Article 31, Five categories of pharmaceutical establishments: Article 2 of Executive Decree 21-82 — https://www.grzanglobal.com/algeria-medical-device-registration/five-types-of-pharmaceutical-establishments/
• Article 11, The standard homologation process: six stages from dossier submission to decision — https://www.grzanglobal.com/algeria-medical-device-registration/standard-homologation-process-six-stages/

Regulatory information verified as of October 30, 2026.

GRZAN provides registration and compliance support for medical device and IVD manufacturers entering the Algerian market, including homologation dossier preparation, pharmaceutical establishment licensing coordination, classification consulting and post-market compliance management. For professional assistance with ANPP procedures and Ministry of Pharmaceutical Industry requirements, contact info@grzanglobal.com.