Fee Anchors for Modification, Renewal and Transfer

1. Key takeaways

The official fees for devices in Algeria are established by Article 31 of Ordonnance n° 21-07 and implemented by Article 2 of Décret exécutif n° 21-551. The three device-side tiers are: modification of the homologation decision 150.000 DA, renewal of the homologation decision 300.000 DA, and transfer of the homologation decision between pharmaceutical establishments 100.000 DA. Applying alongside devices are the establishment expert-review fee and the clinical trial authorisation and certification fees, each 300.000 DA. The allocation ratio is 70 percent into the special account 302-096 and 30 percent to the ANPP.

Together with the batch control tax of Executive Decree n° 21-552, these rates constitute the full fee map of an Algerian device project. Every budget line for the registration life cycle — modification, renewal, transfer, laboratory testing — can be anchored to one of these published figures, with one deliberate exception noted below for the initial homologation.

2. Legal basis

1. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of 30 December 2021 on the collection and allocation of the redevance on pharmaceutical products and medical devices, JORADP No. 02, published 5 January 2022, pages 14–15): Article 2 (10 fee items and the 70/30 allocation).
2. Ordonnance n° 21-07 du 27 Chaoual 1442 correspondant au 8 juin 2021 portant loi de finances complémentaire pour 2021 (Ordinance No. 21-07 of 8 June 2021 containing the supplementary finance law for 2021, JORADP No. 44, published 8 June 2021, page 10): Article 31 (amends Article 68 of Loi n° 99-11 and establishes the redevance fee schedule).
3. Décret exécutif n° 21-552 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités d’acquittement et d’affectation du produit de la taxe de contrôle et expertise de lot de produit pharmaceutique et/ou de dispositif médical (Executive Decree No. 21-552 of 30 December 2021 on the payment and allocation of the batch control and expertise tax on pharmaceutical products and/or medical devices, JORADP No. 02, published 5 January 2022, pages 15–16): Article 2 (batch control tax: 30.000 DA per device batch, 60.000 DA for testing on homologation, modification and renewal, 24.000 DA for device raw materials).
4. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of 30 December 2021, JORADP No. 02, published 5 January 2022, pages 14–15): Article 3 (payment in full into the account of the bank where the ANPP is domiciled, on the basis of the payment slip, with payment evidenced by bank documents).

3. Expert insights

Insight 1: the fee schedule of Executive Decree No. 21-551 is a single 10-item table covering drugs and devices together. Article 2 lists 10 items: registration on the reimbursement list 15.000 DA, modification of registration on the reimbursement list 5.000 DA, establishment expert review 300.000 DA, clinical trial authorisation 300.000 DA, clinical trial certification 300.000 DA, drug registration modification 150.000 DA, drug registration renewal 300.000 DA, drug registration transfer 100.000 DA, device homologation modification 150.000 DA, device homologation renewal 300.000 DA, device homologation transfer 100.000 DA. (The 10 items cover drugs and devices; the device side consists of the last three.) Reading the table as one instrument makes the relative weights of the various procedures immediately visible.

Insight 2: devices and drugs pay identical amounts for the same type of procedure. The comparison shows: registration or homologation modification 150.000 DA in both cases, renewal 300.000 DA in both cases, transfer 100.000 DA in both cases. The legislature did not add a surcharge for devices. The cost pressure of device projects therefore comes mainly from the batch control tax rather than from the homologation fees themselves — a conclusion that should shape both the budget structure and the negotiation posture with local partners.

Insight 3: the 70/30 allocation signals a stable revenue incentive for the ANPP. The final paragraph of Article 2 provides that 70 percent of the revenue enters the special account 302-096, the fund for emergency medical care and care activities, and 30 percent goes to the ANPP. This allocation shows the fees have an explicit destination and are not informal charges; companies should treat them in the budget as certain, committed expenditure rather than as negotiable or contingent costs.

Insight 4: the fee for the initial homologation is not in this schedule and must follow the ANPP payment slip (practical estimate). Article 2 of Executive Decree No. 21-551 enumerates modification, renewal and transfer only; the rate for the initial homologation application (demande d’homologation initiale) is not listed. Article 21 of Executive Decree No. 20-324 and Article 2 of the Ministerial Order of 2021 both state only that fees must be paid, without figures. GRZAN’s handling: the initial homologation fee is applied as stated on the payment slip issued by the ANPP, and is estimated as a practical estimate in budgeting with a floating reserve.

4. Practical recommendations

1. Structure the fee budget in three tiers: modification 150.000 DA, renewal 300.000 DA, transfer 100.000 DA.
2. State the initial homologation fee separately and apply it per the ANPP payment slip, with a floating reserve in the budget (practical estimate).
3. Add the control tax of Executive Decree n° 21-552: 30.000 DA per batch, 60.000 DA for homologation, modification and renewal testing, 24.000 DA per raw material.
4. Consider exchange-rate movements in the budget and update the conversion of the dinar into RMB and USD quarterly.
5. Keep the bank documents after payment; these are the proof of payment required by Article 3.
6. Review the fee schedule every six months for adjustments by new finance laws.

5. Verification checklist

• □ The three fee tiers are listed separately in the budget.
• □ The initial homologation fee is stated separately and marked as a practical estimate.
• □ The three tiers of the control tax are added into the budget.
• □ An exchange-rate conversion mechanism is in place (quarterly updates).
• □ Bank documents are retained as required by Article 3.
• □ A semi-annual review mechanism for the fee schedule is in place.

Further reading in this series: The batch control tax: what 30,000, 60,000 and 24,000 dinars each correspond to — https://www.grzanglobal.com/algeria-medical-device-registration/batch-control-tax-dmd-amounts/ ; Payment method and proof: the payment route of Article 3 of Executive Decree 21-551 — https://www.grzanglobal.com/algeria-medical-device-registration/payment-method-and-quittance-article-3/ ; 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/

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, fee budgeting against the redevance schedule of Executive Decree n° 21-551 and the control tax of n° 21-552 in Algerian dinars (DZD), and end-to-end registration cost planning. For assistance with budget construction or any question on this topic, contact info@grzanglobal.com.