Azerbaijan Medical Device Documentation: Language and Notarized Translation Requirements

1. Key takeaways

The language requirement for device documents in Azerbaijan is not a blanket requirement to translate everything into Azerbaijani. Instead, the rules precisely name three places.

First, Article 4.2.2: the foreign registration certificate or free sale certificate must be submitted with a notarized Azerbaijani translation.

Second, Article 4.2.7: for sterile devices, the test methods and packaging validation, microbiological (bioburden level), pyrogenicity and sterility test results, and process validation information must be submitted with a notarized Azerbaijani translation.

Third, Article 9.1: the instructions for use of a device containing drug substances must be submitted as a notarized Azerbaijani translation, checked by AEC and confirmed by the Ministry of Health.

In addition, Article 4.2.4 requires labels and packaging to be submitted as color proofs with Azerbaijani content, which is a content requirement rather than a translation requirement. Beyond these points, the Rules do not require the entire technical documentation to be converted into Azerbaijani.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024, approving the Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Collection 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Article 4.2.2 (notarized Azerbaijani translation of the foreign registration certificate or free sale certificate), Article 4.2.4 (color proofs of labels and packaging with Azerbaijani content), Article 4.2.7 (notarized Azerbaijani translation of sterile device documentation), Article 9.1 (notarized Azerbaijani translation of instructions for use for devices containing drug substances, checked by the body and confirmed by the Ministry of Health), Article 9.2 (publication of confirmed instructions for use in PDF format on the AEC official website).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Collection of the Republic of Azerbaijan, 2007, No. 2, item 70), as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, item 1127): Article 6.13 (packaging languages for medicinal products, not applicable to devices under Article 1-1).
• Law of the Republic of Azerbaijan on Medicinal Products (same publication details as above), as amended by Law No. 979-VIQD of July 14, 2023: Article 1-1 (the list of excluded provisions).

3. Expert insights

Insight 1: the reach of Article 9.1 is narrower than many people assume. The full wording of Article 9.1 covers the instructions for use of medicinal products and devices containing drug substances. The instructions for use of a pure device, one without drug substances, are not within the mandatory notarized translation scope of Article 9.1, and the 11 dossier items of Article 4.2 do not list instructions for use at all. This difference is often miswritten in secondary sources as a requirement that instructions for use of all devices be notarized and translated.

Insight 2: the nine-language concession of Article 6.13 does not apply to devices. Article 6.13 permits the registration and import for sale of medicinal products packaged in Azerbaijani, Turkish, Russian, English, German, Spanish, Italian, French or Hungarian. But Article 1-1 places Article 6.13 on the list of provisions that do not apply to devices. Device labels and packaging content follow Azerbaijani under Article 4.2.4, so do not cite Article 6.13 to claim a multilingual exemption.

Insight 3: the cost of notarized translations concentrates on sterile devices and devices containing drug substances. The content of the translations required by Article 4.2.7 is highly technical, covering validation, bioburden, pyrogenicity, sterility and process validation, and a single mistranslated term can trigger Article 5.1.4, under which inconsistencies related to quality, efficacy or safety are found in the submitted documents. Such documents should be translated by a translator with a medical device background and then certified by an Azerbaijani notary.

Insight 4: Article 9.2 puts instructions for use into the public domain. The confirmed instructions for use of registered medicinal products and devices are published by AEC in PDF format on its official website. This means the instructions are not an internal document: once confirmed they are public, and both wording and risk management must be drafted to public document standards.

4. Practical recommendations

1. Build a language and notarization checklist: obtain notarized translations only for the three places covered by Articles 4.2.2, 4.2.7 and 9.1, and keep the remaining documents in their original language with an explanatory cover in English or Russian.
2. Produce the Azerbaijani label and packaging versions directly under Article 4.2.4, and retain both an electronic and a printed copy of the color proofs.
3. For devices containing drug substances, run the instructions for use through the three steps of submission by the applicant, checking by AEC and confirmation by the Ministry of Health under Article 9.1, and reserve separate time for the checking and confirmation stages in the schedule.
4. Have the technical translations for sterile devices completed by translators with device backgrounds, and ask the manufacturer’s technical department to review the terminology once before notarization.
5. Draft and review the instructions for use to the standard of a document that will be published, so that internal annotations and unverified performance claims never appear in the confirmed version.
6. Do not cite Article 6.13 to seek a multilingual packaging exemption for devices; if other languages are needed, the Azerbaijani content must still be complete.

5. Verification checklist

• □ The notarized translation list for this project has been compiled under Articles 4.2.2, 4.2.7 and 9.1.
• □ It has been confirmed whether the product contains drug substances, and therefore whether Article 9.1 applies.
• □ Azerbaijani color proofs of labels and packaging have been completed (Article 4.2.4).
• □ The technical translations for the sterile device have been completed by a translator with a device background and reviewed for terminology by the manufacturer.
• □ The confirmed instructions for use have been reviewed to the published document standard (Article 9.2).
• □ Any drafting that relies on the multilingual exemption of Article 6.13 has been excluded.

Related reading

• Article 05. Four Risk Degrees: Low, Medium, High and Higher (Classes 1, 2a, 2b and 3): https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-risk-degrees-class-1-2a-2b-3/
• Article 06. Low Risk Devices Are Not Registered: the Boundary of Exemption and Import Permits: https://www.grzanglobal.com/azerbaijan-medical-device-registration/low-risk-devices-exemption-and-import-permit/
• Article 25. Notarized Translation of Instructions for Use: Only for Devices Containing Drug Substances: https://www.grzanglobal.com/azerbaijan-medical-device-registration/notarized-translation-of-instructions-for-use/

This article was translated and published by GRZAN, the international regulatory affairs service of GRZAN Global. For professional support with medical device registration in Azerbaijan, regulatory strategy, dossier preparation and local representation, contact us at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.