Withdrawal after 18 Months without Effective Marketing or Export

1. Key takeaways

Article 37 of Décret exécutif n° 20-324 is an easily overlooked dormant clause: during the validity of the homologation decision, if the device has not been effectively marketed or exported within 18 months of the issue of the decision, the ANPP may withdraw the decision. Together with the 5-year validity of Article 34 and the 90-day renewal of Article 35, it forms one of the three lines of certificate life-cycle management in Algeria. The assessment of GRZAN: the 18-month clock is a hidden deadline that expires earlier than the 5-year validity.

In other words, obtaining the certificate is only the first half of the project. The second half is proving, with documents, that real commercial activity has occurred before the 18-month mark. Companies that treat the certificate as a passive credential often discover this clause only when the withdrawal notice arrives, at which point the options narrow considerably.

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 37 (if not effectively marketed or exported within 18 months, the ANPP may withdraw the decision).
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 22 November 2020, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 34 (5-year validity), Article 35 (renewal 90 days before expiry).
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, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 38 (temporary withdrawal of not more than 12 months), Article 39 (lifting or conversion to definitive withdrawal), Article 40 (7 categories of initiating bodies).
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, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles in total): Article 41 (after withdrawal, distribution must cease and batches must be recalled, destroyed or returned, at the expense of the holder and/or the operator).

3. Expert insights

Insight 1: Article 37 uses may (peut), so it is a discretionary clause, not automatic lapse. The wording of Article 37 is that the ANPP may proceed to the withdrawal (l’agence peut procéder au retrait). This differs from Article 23, under which a licence lapses automatically after 2 years without operation. A discretionary clause means the company has room for explanation and remediation, but only if it acts proactively. Waiting passively for the agency to decide forfeits exactly the space the clause leaves open.

Insight 2: the clock starts at the issue of the decision, and the condition is no effective marketing or export. Article 37 refers to a decision n’ayant pas fait l’objet d’une commercialisation ou d’exportation effective within 18 months of issue. The key word is effective: signed orders, customs declarations and sales records count; market preparation alone does not. Companies must therefore preserve the evidence chain of actual transactions — purchase orders, invoices, customs documents, release records — because these documents are the only currency recognised when the 18-month question is raised.

Insight 3: this clause is linked to the cost-allocation rule of Article 41. Article 41 provides that once a decision is withdrawn, distribution must cease and the relevant batches must be recalled, destroyed or returned, with the costs borne by the holder and/or the operator. Triggering Article 37 therefore costs more than the certificate itself: inventory disposal costs also fall on the two local parties. This cost exposure should be quantified and reserved in the budget before it materialises, particularly for high-value devices held in stock.

Insight 4: the relationship between 18 months and 5 years is the earlier deadline prevails. Article 34 grants 5 years; Article 37 sets 18 months. When both run in parallel, the 18-month mark is the earlier pressure point. When planning the launch schedule, a company cannot push commercialisation into the third year merely because the certificate is valid for 5 years. The launch plan must be back-calculated from the issue date, with the first effective sale targeted well inside the 18-month window.

4. Practical recommendations

1. Set 18 months after issue as the second key date in the certificate register, alongside the expiry date.
2. Archive the evidence of actual sales of the first batch completely: orders, invoices, customs declarations, release records.
3. If marketing within 18 months is not expected, notify the ANPP in advance in writing with the reasons and the launch plan.
4. Back-calculate the launch schedule so that the first delivery falls within 12 months of issue, leaving a 6-month buffer.
5. If a notice of intended withdrawal is received, submit evidence of marketing or a marketing commitment with a timetable immediately.
6. Assess inventory disposal costs after withdrawal and reserve them in the budget.

5. Verification checklist

• □ The certificate register contains the key date of 18 months after issue.
• □ The evidence chain of actual sales of the first batch is fully archived.
• □ Where marketing may be delayed, written notice has been given in advance.
• □ The first delivery is scheduled within 12 months of issue.
• □ Response materials (evidence or commitment) for a withdrawal notice are ready.
• □ Inventory disposal costs are reserved in the budget.

Further reading in this series: Five-year validity and the 90-day renewal window: Articles 34 and 35 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/five-year-validity-90-day-renewal-window/ ; Temporary and definitive withdrawal: Articles 38 to 42 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/temporary-and-definitive-withdrawal/ ; 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/

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, marketing-time monitoring under Article 37 of Executive Decree n° 20-324, and complete fee budgeting in Algerian dinars (DZD). For assistance with launch planning or any question on this topic, contact info@grzanglobal.com.