Azerbaijan Medical Device Registration 2026: Notarised Translation of Instructions for Use for Devices with Medicinal Substances

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The mandatory notarised translation of Article 9.1 covers only the instructions for use of medicinal products and of devices containing medicinal substances. That article provides that the notarised Azerbaijani translation of the instructions for use of medicinal products and devices containing medicinal substances is submitted by the applicant, checked by the authority (AEC) and confirmed by the Ministry of Health. Article 9.2 further provides that the confirmed instructions for use of registered medicinal products and devices are published by the AEC in PDF format on its official website.

The key gap here is that the eleven-item dossier for devices under Article 4.2 does not list the instructions for use as a separate item. Consequently, the instructions for use of a pure device (one that contains no medicinal substance) are not covered by the mandatory notarised translation, while the instructions for a device containing a medicinal substance must pass through the full three steps of submission, checking and confirmation. This distinction has a direct impact on translation budgets, notarisation costs and project timelines.

2. Legal basis

Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Article 9.1 (notarised translation of the instructions for medicinal products and devices containing medicinal substances, submitted by the applicant, checked by the authority, confirmed by the Ministry of Health), Article 9.2 (confirmed instructions published in PDF on the AEC website), Article 4.4 (devices containing medicinal substances first undergo expertise by the AEC), Article 7.1 (certificate issued within 7 working days of submission of the expertise opinion for devices under Article 4.4), Article 10.5 (instructions uploaded electronically to the register).
Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Article 4.2 (eleven-item dossier, which does not list the instructions for use), Article 4.3 (list of exemptions).
Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan of December 25, 2019 on the Rules for the Conduct of Expertise of Medicinal Products (including simplified expertise) (Xalq qəzeti No. 290 of December 28, 2019; Legislative Compilation 2019, No. 12, item 2083; effective July 1, 2020) (expertise rules).

3. Expert insights

Insight 1: The scope of Article 9.1 is widely overstated by secondary sources. A common claim is that Azerbaijan requires a notarised Azerbaijani translation of the instructions for use of all devices. The wording of the official provision is medicinal products and devices containing a medicinal substance (dərman vasitəsinin və tərkibində dərman maddəsi olan tibb vasitəsinin). Pure devices are not covered. This difference matters greatly for cost and scheduling: a device containing a medicinal substance requires an additional round of translation, notarisation, checking by the AEC and confirmation by the Ministry of Health.

Insight 2: The three-step process means the instructions are an approved document, not merely a received document. The three actions of Article 9.1, submission by the applicant, checking by the AEC and confirmation by the Ministry of Health, make the instructions one of the few device documents that undergo substantive confirmation by the competent authorities. The confirmed version is published under Article 9.2. Once confirmed, any change of wording requires the process to be repeated. Editing the instructions after confirmation without re-approval creates a discrepancy between the published text and the marketed product.

Insight 3: The publication mechanism of Article 9.2 turns the instructions into an external commitment. The confirmed instructions are published as a PDF on the AEC website. The indications, contraindications, steps for use and warnings in the instructions are all public product commitments. They should therefore be reviewed to the standard of a public document, avoiding unverified performance claims, internal codes, or fields of application that are inconsistent with the brief description under Article 4.2.3.

Insight 4: The instructions for devices with medicinal substances and the prior expertise under Article 4.4 run on two parallel tracks. Article 4.4 governs the expertise of the quality, effectiveness and safety of the medicinal substance; Article 9.1 governs the checking and confirmation of the translation of the instructions. Both involve the AEC, but the outcomes do not synchronise. Schedules should track the confirmation of the instructions separately from the expertise opinion, to avoid the mistaken assumption that once the expertise is passed the instructions are automatically confirmed.

4. Practical recommendations

First determine whether the product contains a medicinal substance, and decide on that basis whether Article 9.1 applies; a pure device is not subject to the mandatory notarised translation.
For devices containing medicinal substances, schedule the three steps of submission, checking by the AEC and confirmation by the Ministry of Health, and keep separate records of each step.
Draft and review the instructions to the standard of a document that will be published, and keep them consistent with the fields of application in the brief description under Article 4.2.3.
Set up a version register once the instructions are confirmed; treat any change of wording as a change and repeat the confirmation process.
For devices containing medicinal substances, track the confirmation of the instructions and the expertise under Article 4.4 separately, without letting one substitute for the other.
Keep the confirmed Azerbaijani PDF and check it against the version published on the AEC website.

5. Verification checklist

□ It has been determined whether the product contains a medicinal substance, and whether Article 9.1 applies.
□ The notarised Azerbaijani translation has been completed for devices containing medicinal substances.
□ The three steps have been scheduled and recorded separately (submission, checking by the AEC, confirmation by the Ministry of Health).
□ The instructions have been reviewed to the published-document standard and are consistent with the description under 4.2.3.
□ A version register for the instructions has been established.
□ The locally held confirmed version has been checked against the version published on the AEC website.

Related reading: Labelling and Packaging: Azerbaijani Colour Mock-ups (https://www.grzanglobal.com/azerbaijan-medical-device-registration/labelling-and-packaging-azerbaijani-mockups/); Biosafety Information: When It Can Be Omitted (https://www.grzanglobal.com/azerbaijan-medical-device-registration/biosafety-information-exemptions/); Devices Containing a Medicinal Substance: The Additional Track of Expertise before Registration (https://www.grzanglobal.com/azerbaijan-medical-device-registration/devices-containing-medicinal-substance/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, Azerbaijani translation and notarisation, instructions confirmation and AEC liaison. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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