Azerbaijan Medical Device Registration 2026: Labelling and Packaging with Azerbaijani Colour Mock-ups

1. Key takeaways

Article 4.2.4 requires the labelling and packaging information for the device issued by the manufacturer, and its formal requirements are two: colour mock-ups of the packaging and labelling (rəngli maketləri) and content in the Azerbaijani language (Azərbaycan dilində məzmunu). This is the only item in the eleven-item dossier that points directly at the physical appearance of the product.

Two further provisions connect to it: Article 10.4.4 enters the description of the primary and (or) secondary packaging among the register fields, and Article 10.5 provides that the certificate, the description of the primary or secondary packaging and the instructions for use are uploaded to the register in electronic format. Article 11.1.3 moreover lists failure to comply with packaging and marking requirements, where a formal warning issued by the authority to the certificate holder has not been heeded, as a statutory ground for suspension of the registration. Labelling compliance in Azerbaijan is therefore not a cosmetic issue but a market-access issue.

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 4.2.4 (colour mock-ups and Azerbaijani content), Article 10.4.4 (packaging description entered in the register), Article 10.5 (electronic upload of the packaging description), Article 11.1.3 (suspension where packaging and marking requirements are not met and a warning is not heeded), Article 11.4 (suspension published in the media under Article 16 of the Law on Medicinal Products).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında), No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Compilation 2007, No. 2, item 70, as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 with new wording, Legislative Compilation 2023, No. 8, item 1127): Article 6.13 (packaging languages for medicinal products, not applicable to devices by virtue of Article 1-1), Article 1-1 (list of excluded articles), Article 16 (publication).
• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of May 21, 2024 on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicinal Products; signed by Minister Teymur Musayev; sent to the Ministry of Justice within 3 days of adoption for entry in the register of legal acts): Article 3.1.4 (sterility as a classification dimension), Article 2.1.2 (risk degree).

3. Expert insights

Insight 1: Article 11.1.3 elevates labelling compliance to the level of registration suspension. This is one of the few enforcement clauses in the Rules that targets the physical state of the device: where the packaging and marking do not meet the requirements and a formal warning issued by the AEC to the certificate holder has not been heeded, the registration is suspended. Under Article 11.2 the consequence of suspension is that import, domestic production and sale, and use all stop. For distributors this is the most easily overlooked fatal risk point, because the packaging is usually prepared far from the registration team.

Insight 2: The nine-language concession of Article 6.13 does not apply to devices, and this must be repeatedly confirmed. Article 6.13 allows medicinal products packaged in Azerbaijani, Turkish, Russian, English, German, Spanish, Italian, French or Hungarian to be registered, imported and sold. However, Article 1-1 of the Law on Medicinal Products places Article 6.13 on the list of provisions that do not apply to devices. Device packaging follows Article 4.2.4 and uses Azerbaijani; multilingual versions may coexist, but the Azerbaijani content must be complete.

Insight 3: The colour mock-ups are the filed document, while the physical packaging is the post-market state, and the two must remain capable of being matched. Article 4.2.4 requires colour mock-ups (maket), and Article 10.5 uploads the packaging description to the register electronically. If the packaging is redesigned after market entry, for example a new design, new material or a new barcode, it may become inconsistent with the description on the register even if the Azerbaijani content is unchanged, which triggers the warning procedure of Article 11.1.3.

Insight 4: The sterile status must be reflected on the packaging. Article 3.1.4 of Decision No. 8 lists sterility as a classification dimension, and the packaging is usually the main carrier of this information. Where the classification relies on supply in sterile condition, the packaging must carry the corresponding marking; otherwise the inconsistency may be questioned in the review of inconsistent documents under Article 5.1.4.

4. Practical recommendations

1. Prepare colour mock-ups of the packaging and labelling under Article 4.2.4, one electronic draft and one printed draft, with the content entirely in Azerbaijani.
2. Do not invoke Article 6.13 to claim a multilingual exemption; where several languages coexist, the Azerbaijani content must be complete.
3. Bring packaging redesigns under change management: evaluate any change of design, material, barcode or marking against a possible change of state registration under Article 1.5 before implementation.
4. Establish a quarterly comparison between the physical packaging and the register description under Article 10.4.4, so as to avoid triggering Article 11.1.3.
5. When a formal warning from the AEC on packaging or marking is received, complete the rectification within the warning period and reply in writing under Article 11.1.3.
6. Reflect the sterile marking on the packaging of sterile products and keep it consistent with the classification rationale document.

5. Verification checklist

• □ Colour mock-ups of the packaging and labelling (electronic and printed) have been prepared with content in Azerbaijani.
• □ It has been confirmed that the multilingual exemption of Article 6.13 has not been invoked.
• □ Packaging redesigns have been brought under change management procedures.
• □ A quarterly comparison between the physical packaging and the register description under 10.4.4 has been established.
• □ A 48-hour response mechanism for AEC packaging warnings has been established.
• □ The packaging of sterile products carries the sterile marking and is consistent with the classification rationale document.

Related reading: Brief Description: Scope, Purpose and Accessories (https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/); Notarised Translation of Instructions for Use: Only for Devices with Medicinal Substances (https://www.grzanglobal.com/azerbaijan-medical-device-registration/notarized-translation-of-instructions-for-use/); Suspension of Registration: Four Situations and a Full Stop to Import, Sale and Use (https://www.grzanglobal.com/azerbaijan-medical-device-registration/suspension-of-state-registration/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, Azerbaijani labelling and packaging review, warning and suspension response and post-market obligations. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.