Azerbaijan Medical Device Registration Fees: State Duty, Assessment Fees and the 5-Working-Day Payment Window

1. Key takeaways

The fees for device registration in Azerbaijan have three layers:

First layer, the state duty — Article 6.10 of the Law on Medicinal Products provides that the national registration and re-registration of medicinal products and pharmacologically active substances, the national registration of changes to their registration documents, and the issuance of sanitary certificates are subject to the state duty under the Law on State Duty; paragraph 6.16 of Rule No. 345 requires the applicant to pay within 5 working days of receiving the notification of the authority (AEC).

Second layer, expert assessment and testing fees — paragraph 4.4 requires devices containing pharmacologically active substances to undergo expert assessment by the AEC first, and that assessment is implemented under Resolution No. 502.

Third layer, the tariff table published by the AEC — the Rates section of the AEC website publishes the tariff table annexed to Decision No. 10 of the Tariff (Price) Committee of December 5, 2023. The table lists medicinal product items (pre-assessment, originator products, generics, renewals, various changes, pharmacovigilance and so on) and does not list medical device items.

Accordingly, this series treats the specific amounts for devices on a practical estimate basis: the payment notification issued by the AEC at the time of filing prevails, and no amounts are extrapolated from the medicinal product tariffs.

2. Legal basis

• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, Law of the Republic of Azerbaijan No. 208-IIIQ, adopted on December 22, 2006, entered into force on February 28, 2007, Collection of Legislation of the Republic of Azerbaijan, 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of July 14, 2023 (which added Articles 1-1 and 9-1 as new provisions, Collection of Legislation, 2023, No. 8, Article 1127): Article 6.10 (state duty), Article 6.16 (payment within 5 working days of notification by the authority), Article 4.4 (devices containing pharmacologically active substances undergo AEC expert assessment first), Article 6.14 (no state duty for a duplicate certificate), paragraph 7.11 (devices apply Article 6.14 for lost or damaged certificates).
• Tariff table annexed to Decision No. 10 of the Tariff (Price) Committee of the Republic of Azerbaijan of December 5, 2023 (published in the Rates section of the AEC website; Appendix 3 effective from May 1, 2025) — the table lists medicinal product items and does not list medical device items (the tariff table published on the AEC website contains medicinal product items; medical device items are not listed).
• Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 502 of December 25, 2019, on the Rules for Carrying Out Expert Assessment of Medicinal Products (including simplified assessment) (Xalq qəzeti, December 28, 2019, No. 290; Collection of Legislation, 2019, No. 12, Article 2083; effective from July 1, 2020) (rules for carrying out expert assessment).
• Law of the Republic of Azerbaijan on Medicinal Products (same act): Articles 1-1 and 6.10 as the referencing basis for Article 6.16.

3. Expert insights

Insight 1: The absence of device items in the official tariff table is itself significant information. The tariff table published in the Rates section of the AEC website covers pre-assessment, originator and generic products, renewals, various changes and pharmacovigilance items for medicinal products, but contains no medical device entries. This shows that fees for devices have not yet been tabulated separately; in practice they are either set by reference to medicinal product items or determined case by case. This series does not extrapolate amounts; it provides only the process and the legal basis.

Insight 2: The 5-working-day payment window is a hard gate in the process. Paragraph 6.16 places payment within 5 working days after receipt of the notification of the authority. For a foreign applicant, those 5 working days must span: arrival of the AEC notification at the local entity, forwarding abroad, internal approval, foreign exchange payment and confirmation of receipt. A delay at any single link causes an overrun.

Insight 3: The duplicate certificate is free of charge — the only item expressly written as free in the Rules. Paragraph 6.14 provides that where a certificate is lost or damaged, a duplicate is issued without charging the state duty; the damaged certificate must be returned to the Ministry of Health. Devices apply paragraph 7.11, which refers to paragraph 6.14. This is the only item in the cost list that can be confirmed as zero.

Insight 4: The fee structure for devices containing pharmacologically active substances has one more layer than ordinary devices. Paragraph 4.4 requires such devices to undergo AEC expert assessment before national registration, and the assessment is carried out under Resolution No. 502. The assessment fee and the state duty are two different payments, collected by different parties at different points. The cost model for these devices must be built on two layers: assessment fee plus state duty.

Insight 5: The proof of payment can itself become a process node. Article 19.11 of the Law on Licenses and Permits, which sits alongside Article 18.2, provides that after the document proving payment of the state duty (payment) is submitted to the license and permit issuing authority, the license or permit is issued to the applicant no later than 2 working days. Although this provision concerns permits rather than national registration, it signals a practical move: retaining and proactively submitting the proof of payment accelerates issuance.

4. Practical recommendations

1. Build the fee budget on two layers, the state duty plus the assessment fee where applicable; amounts follow the AEC payment notification, with no extrapolation from medicinal product tariffs.
2. Set up the foreign exchange payment chain in advance and start the payment process on the day the AEC notification is received, so that payment completes within 5 working days.
3. Obtain the proof of payment immediately after paying and submit it proactively to the receiving department to accelerate subsequent issuance (by analogy with Article 19.11 of the Law on Licenses and Permits).
4. List the AEC assessment fee for devices containing pharmacologically active substances separately and do not merge it with the state duty estimate.
5. Duplicate certificates are free of charge (paragraphs 6.14 and 7.11); damaged certificates must be returned to the Ministry of Health.
6. Review the Rates section of the AEC website every six months to check whether a device tariff table has been added.

5. Verification checklist

• □ The budget has been built on two layers: state duty plus assessment fee.
• □ No amounts have been extrapolated from medicinal product tariffs; the practical estimate basis has been documented.
• □ The payment chain is in place and payment can complete within 5 working days.
• □ A process for obtaining, submitting and archiving proofs of payment is in place.
• □ The assessment fee for devices containing pharmacologically active substances is listed separately.
• □ A six-monthly review reminder for the AEC Rates section has been set.

Regulatory information verified as of October 30, 2026.

This article was prepared and translated by GRZAN as part of the international medical device registration guide. For professional support with regulatory submissions in Azerbaijan and other jurisdictions, contact info@grzanglobal.com.