Temporary and Definitive Withdrawal of Medical Device Homologation Decisions: Articles 38 to 42

1. Key takeaways

Articles 38 to 42 of Décret exécutif n° 20-324 form the withdrawal regime.

Temporary withdrawal may not exceed 12 months (Article 38);

where the reservations have not been lifted when that period expires, the withdrawal becomes definitive (Article 38, second paragraph);

the lifting of a withdrawal, or its conversion into a definitive one, is decided by the Director General upon the opinion of the committee (Article 39);

after withdrawal, distribution must stop and the batches must be recalled, destroyed or returned, at the expense of the holder and/or the operator (Article 41).

Article 42 additionally sets out the information-notification duties that follow a withdrawal.

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 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 38 (temporary withdrawal not exceeding 12 months, converting into definitive withdrawal on expiry) and Article 39 (lifting or conversion decided by the Director General upon the opinion of the committee).
2. 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 41 (cessation of distribution and disposal of batches, and who bears the cost) and Article 42 (information notification).
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 40 (the seven categories of bodies that may request withdrawal).
4. 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 37 (withdrawal where the device has not been marketed within 18 months) and Article 31 (grounds for refusal).
5. 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 (Order of 23 June 2021 on the modalities of homologation of medical devices manufactured locally and destined exclusively for export, JORADP No. 62, published on 15 August 2021, pages 23–25, 20 articles in total), Articles 17 to 19 (withdrawal of export-only devices and cessation of export).

3. Expert insights

Insight 1: 12 months is the ceiling for temporary withdrawal, not a fixed duration for every withdrawal.

The wording of Article 38 is that temporary withdrawal is granted “for a period not exceeding twelve months (pour une durée n’excédant pas douze mois)”. ANPP may therefore set a shorter period according to the seriousness of the problem, with 12 months as the statutory ceiling. Businesses should run their cash-flow assessments on the worst case of a full 12 months off the market, because the regulator is under no duty to grant the maximum and no duty to lift early.

Insight 2: conversion to definitive withdrawal requires no new request — it is the automatic consequence of expiry.

Article 38, second paragraph: “where, at the end of that period, the reservations have not been lifted, the withdrawal becomes definitive (devient définitif)”. This is an automatic conversion mechanism. A company cannot wait until month 11 to act; the corrective action plan must be laid out the moment the withdrawal notice is served, with the 12-month clock assumed to be running from day one.

Insight 3: the power to lift or convert rests with the Director General, but upon the committee’s opinion.

Article 39: the lifting of a temporary withdrawal, or its conversion into a definitive withdrawal, is decided by the Director General of ANPP on the basis of the committee’s opinion. This mirrors the structure of the issuance procedure under Article 30 — committee opinion followed by a decision — which means that lifting a withdrawal also requires a pass through the committee. The timetable is therefore not controlled by the company alone.

Insight 4: Article 41 places disposal costs squarely on the holder and the operator.

Article 41: once a decision is withdrawn, distribution must cease and the batches concerned must be recalled, destroyed or returned, at the expense of the holder and/or the operator. Read together with the joint responsibility of Article 9 of Executive Decree No. 21-82, the two parties are jointly exposed externally, while the internal split depends on the delegation contract between them.

4. Practical recommendations

1. Start corrective action on the day the withdrawal notice is received and plan against the worst case of 12 months.
2. Set monthly milestones in the corrective plan so that the conditions for lifting the withdrawal are met by month 10 at the latest.
3. Proactively submit interim corrective progress to ANPP to build positive material for the committee opinion under Article 39.
4. Assess stock levels in parallel and estimate the cost of recall, destruction or return under Article 41.
5. Allocate costs with the operator according to the responsibility matrix in the delegation contract, so that internal disputes do not delay the corrective work.
6. Perform the information-notification duty of Article 42 continuously throughout the withdrawal period.

5. Verification checklist

• □ Corrective action started on the day of the withdrawal notice, with the plan built on the worst case of 12 months.
• □ The corrective plan contains monthly milestones (conditions for lifting met by month 10).
• □ Interim corrective progress has been proactively submitted to ANPP.
• □ Stock levels and disposal costs have been estimated under Article 41.
• □ Cost sharing with the operator has been agreed under the responsibility matrix.
• □ The Article 42 information-notification duty is being performed during the withdrawal period.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market, including management of temporary and definitive withdrawal proceedings, batch recall and disposal coordination, communication with ANPP and local operators, and preparation of the evidence file needed for lifting a withdrawal. For support with withdrawals, recalls and inspection responses in Algeria, contact info@grzanglobal.com.