Locally Manufactured, Export-Only Devices: A Separate Algerian Homologation Pathway

1. Key takeaways

Algeria maintains a separate pathway for medical devices that are locally manufactured and intended exclusively for export. Article 16(2) of Décret exécutif n° 20-324 authorises a ministerial order to lay down specific rules, and the Ministerial Order of 23 June 2021, with 20 articles, implements that authorisation.

The timeline combination is: an admissibility review of 8 days (Article 6); submission of the file to the commission within 60 days of admissibility (Article 8, extendable by 30 days); an ANPP decision within 90 days (Article 9, extendable by 30 days); notification of the decision within 10 days (Article 10); and a validity period of 5 years (Article 14).

The headline for planning purposes: this channel is not faster at the admissibility stage than the standard route, and its 60-day window for the commission stage is the longest of any channel. Its distinctiveness lies elsewhere — in the mandatory export-only declaration, in the annotation on the decision itself, and in a dual reporting line for withdrawal-relevant information that has no equivalent on the standard route.

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 No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 16(2) (locally manufactured devices intended exclusively for export are governed by a specific ministerial order).
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 homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles): Article 2 (homologation is required), Article 3 (the application must declare that the device is intended exclusively for export), Article 4 (the standard dossier applies), Article 6 (the 8-day admissibility review), Article 8 (submission to the commission within 60 days), Article 9 (the 90-day decision), Article 10 (notification within 10 days), Article 12 (the decision is issued only to approved establishments), Article 13 (the decision must state that the device is intended exclusively for export) and Article 14 (a validity of 5 years).
3. 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 No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 33 (the nine items the decision must contain), Article 35 (renewal) and Article 36 (reporting of changes).
4. 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 No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 38 (temporary or permanent withdrawal).

3. Expert insights

Insight 1: export-only status is not an exemption; homologation is still required, only the route differs.

Article 2 states the rule without qualification: devices manufactured locally and intended exclusively for export must be homologated, in accordance with Executive Decree No. 20-324 and the order itself. Many companies assume that exports escape the regime. In fact Article 16(1) of the decree brings both importation and exportation within the situations that trigger the homologation obligation. What the 2021 order changes is the procedure, not the principle.

Insight 2: the application must contain an explicit declaration that the device is intended exclusively for export.

Article 3(2) requires the application to state clearly that the locally manufactured device is intended exclusively for export, and Article 13(2) goes further: the homologation decision itself must record that the device is locally manufactured and intended exclusively for export. The declaration follows the product onto the certificate, so any plan to sell domestically under the same authorisation would conflict with its own terms.

Insight 3: the 60-day window for the commission stage is unique to this channel.

Compare the four channels: the standard route has no separately specified deadline for the commission stage; regularisation allows 30 days; the modification route has no separately specified deadline; and the export-only channel allows 60 days, extendable by 30 days. The 60 days is the longest submission-to-commission window of the four, reflecting the additional checks on local manufacturing and export compliance that this category requires.

Insight 4: the withdrawal rules point to Article 38 of the decree, and the information must be reported to two places.

Article 17 of the order allows the ANPP to withdraw the decision, temporarily or permanently, on grounds of health safety, performance or quality. Article 18(2) adds a distinctive obligation: information that may constitute grounds for withdrawal must be reported both to the Minister of Pharmaceutical Industry and to the director general of the ANPP. This dual reporting requirement has no counterpart in the standard channel.

4. Practical recommendations

1. If the product is both exported and planned for domestic sale, plan the two routes separately; never let the export route cover domestic marketing.
2. Place the declaration that the device is intended exclusively for export prominently on the first page of the application, consistent with the record under Article 13.
3. Prepare the dossier to the standard requirements of Article 4 of the Ministerial Order of 10 May 2021, which the export order expressly references.
4. Estimate the schedule at the worst case of 8 + 60 + 30 + 90 + 30 + 10 days.
5. Establish an internal escalation flow for information that may constitute grounds for withdrawal, with separate lines to the Minister and to the director general.
6. Manage validity on the 5-year cycle of Article 14, and file renewal under Article 35 within the 90-day advance window.

5. Verification checklist

• □ Export and domestic sale routes have been planned separately, without one covering the other.
• □ The application states the declaration that the device is intended exclusively for export.
• □ The dossier has been prepared to the standard requirements of Article 4.
• □ The schedule has been estimated at the worst-case combination of deadlines.
• □ The dual reporting flow for withdrawal-relevant information is established.
• □ The 5-year validity and the 90-day renewal window are in the compliance calendar.

GRZAN supports local manufacturers and their partners with the Algerian export-only homologation pathway, from the mandatory export declaration and classification strategy to schedule management across the 8-day, 60-day and 90-day deadlines. If your facility manufactures in Algeria for foreign markets, GRZAN can map the pathway and the renewal cycle end to end. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.