Batch Control Tax Amounts for Medical Devices

1. Key takeaways

The batch control tax (taxe de contrôle et expertise de lot) is established by Article 32 of Ordonnance n° 21-07 and implemented by Article 2 of Décret exécutif n° 21-552. The three device-side tiers are: control and expertise of each device batch 30.000 DA; control and expertise of devices in connection with homologation, modification and/or renewal 60.000 DA; testing of device raw materials 24.000 DA. On allocation, the ANPP must remit 50 percent to the treasury account 201.007. The caution from GRZAN: these three tiers use different charging units and must not be mixed in one calculation.

Because the tax is per batch and per procedure rather than per product, it recurs throughout the life of a certificate and frequently exceeds the one-off homologation fees in total. A correct budget therefore multiplies the unit amounts by the number of batches imported and the number of regulatory procedures run over the full life cycle, not merely for the first submission.

2. Legal basis

1. 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 (7 tax items and the three device tiers), Article 4 (the ANPP remits 50 percent to the treasury account 201.007).
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 32 (amends Article 103 of Loi n° 02-11 and establishes the batch control tax).
3. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices for human medicine, JORADP No. 55, published 14 July 2021, pages 21–24, 13 articles in total): Article 7 (submission of samples, raw materials, reagents and specialised means at the request of the ANPP), Article 12 (testing initiated at renewal).
4. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 23 June 2021 on the procedures for modification of the homologation decision for medical devices for human medicine, JORADP No. 62, published 15 August 2021, pages 21–22, 16 articles in total): Article 8 (the modification file must include samples and raw materials), Article 2 (homologation fee and payment voucher).

3. Expert insights

Insight 1: of the 7 tax items in Article 2, the first four concern drugs and the last three concern devices. Article 2 lists: control of imported drug batches 2 DA per sales unit (minimum 30.000 DA); control of locally manufactured drug batches 1 DA per sales unit (minimum 30.000 DA); testing of drug registration modification and renewal 60.000 DA per product; testing of drug raw materials 24.000 DA per raw material; device batch control 30.000 DA; device control on homologation, modification and renewal 60.000 DA; device raw material testing 24.000 DA. The device side consists of the last three items, each with its own unit and trigger.

Insight 2: drugs are priced per sales unit, devices per batch and per procedure. The two drug tiers are charged per sales unit (2 DA or 1 DA, with a minimum of 30.000 DA); the two device tiers are charged per batch (30.000 DA) and per procedure (60.000 DA). This difference means that the import volume of a device does not affect the tax amount, whereas for drugs the import volume directly determines it. Device importers therefore gain no tax saving from consolidating shipments, but equally face no penalty for larger batches.

Insight 3: the trigger for the 60.000 DA tier is homologation, modification and/or renewal. The wording of the sixth item of Article 2 covers control and expertise of devices in cases of homologation, modification and/or renewal. In other words, the initial homologation, each modification and each renewal each count once; the tax is not charged only once at initial homologation. Budgeting must accumulate the 60.000 DA amount across the project life cycle, which for a product renewed once and modified twice means three occurrences of this tier over five years.

Insight 4: the 50 percent remittance to the treasury differs from the 70 percent of the redevance. Article 4 of Executive Decree No. 21-552 provides that the ANPP remits 50 percent to the treasury account 201.007, miscellaneous budget revenues; under Executive Decree No. 21-551, the redevance is allocated 70 percent to the special fund and 30 percent to the ANPP. The different allocation ratios reflect the different legal nature of a tax and a fee. For companies the operational burden is the same, but the accounting treatment must be kept distinct.

4. Practical recommendations

1. Budget the three tiers separately: 30.000 DA per batch, plus 60.000 DA per homologation, modification or renewal, plus 24.000 DA per raw material.
2. Accumulate over the project life cycle: one occurrence at initial homologation, one at each modification, one at each renewal.
3. Use volume-based calculation only for drugs; devices are not priced by volume.
4. Keep the control tax and the redevance in separate accounting lines, matching the different allocations of 50 percent and 70 percent.
5. Archive the tax payment vouchers together with the sample submission records to reconcile the batches charged.
6. Review the tax schedule every six months for adjustments by new finance laws.

5. Verification checklist

• □ The three tiers of the control tax have been calculated separately and included in the budget.
• □ Occurrences of control at homologation, modification and renewal have been accumulated over the life cycle.
• □ The principle that devices are not priced by volume is reflected in the budget.
• □ The control tax and the redevance are kept in separate accounts.
• □ Tax vouchers and sample submission records are archived together.
• □ A semi-annual review mechanism for the tax schedule is in place.

Further reading in this series: Fee anchors: modification 150,000, renewal 300,000, transfer 100,000 dinars — https://www.grzanglobal.com/algeria-medical-device-registration/fee-anchors-modification-renewal-transfer/ ; Samples, reagents and specialised means: the submission duty under ANPP quality control — https://www.grzanglobal.com/algeria-medical-device-registration/samples-reagents-anpp-quality-control/ ; 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/

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, calculation of batch control tax exposure under Executive Decree n° 21-552, and complete fee budgeting in Algerian dinars (DZD). For assistance with tax budgeting or any question on this topic, contact info@grzanglobal.com.