Azerbaijan Import of Used Medical Devices: The Additional Usability Document Requirement

1. Key takeaways

Article 9-1.10 of the Law on Medicinal Products provides that when importing previously used devices, the application must, in addition to the documents listed in Article 9-1.9, be accompanied by a copy of the usability document for the device issued by the manufacturer (seller).

The regular 7 documents of Article 9-1.9 are: 9-1.9.1 an extract from the state register of legal entities or an identity document; 9-1.9.2 evidence of taxpayer registration; 9-1.9.3 evidence of ownership, usage right or lease over the premises (warehouse, area) used to carry out the import; 9-1.9.4 a notarized copy of the sale contract (foreign-language contracts additionally require a notarized Azerbaijani translation); 9-1.9.5 copies of paper and electronic invoices (where the invoice does not state them, information on the full name, serial numbers and use-by or expiry dates must be attached separately); 9-1.9.6 documents on manufacturer quality indicator results confirming conformity of each consignment with its specifications; 9-1.9.7 a certificate of origin.

The usability document for used devices is an additional item and does not replace any of the above.

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): Articles 9-1.9.1 to 9-1.9.7 (seven documents for device import), Article 9-1.10 (additional usability document for used devices), Article 9-1.2 (one permit per consignment), Article 9-1.4 (application before customs entry), Article 9-1.12 (review period follows Article 19.9 of the Law on Licenses and Permits), Article 6.1 (unregistered products may not be imported).
• Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 345 of July 18, 2024, on the Rules for the National Registration of Medicinal Products, Pharmacologically Active Substances and Medical Devices, Their Inclusion in the State Register and the Maintenance of the State Register (entered into force on July 19, 2024; Xalq qəzeti, July 20, 2024, No. 151; Collection of Legislation, 2024, No. 7, Article 906; repealed Resolution No. 108 of July 13, 2007, with effect from July 20, 2024): paragraph 4.2.11 (usability document in the registration dossier for used devices), paragraph 4.3 (the list of exemptions does not cover 4.2.11), paragraph 2.1.1 (definition of the applicant).
• Law of the Republic of Azerbaijan on Licenses and Permits (Lisenziyalar və icazələr haqqında, No. 176-VQ of March 15, 2016), Articles 18.2.1–18.2.3, 19.9, 25 and 26.1: Article 19.9 (7 working days), Article 19.10 (delivery and notification of duty payment).

3. Expert insights

Insight 1: Used devices require the usability document twice — at the registration end and at the import end. Paragraph 4.2.11 (registration dossier) and Article 9-1.10 (import application) each impose the requirement. The registration end speaks of a document issued by the manufacturer, while the import end speaks of one issued by the manufacturer (seller) — the wording on the issuing party differs slightly; the practical estimate is to use an original issued by the manufacturer, and where a document is issued by the seller, to confirm with the AEC first whether it is accepted (pending verification).

Insight 2: Article 9-1.9.5 imposes heavier information requirements for used devices. The provision requires the invoice to state the full name, serial numbers and use-by or expiry dates of every imported device; where the invoice does not state them, the manufacturer (seller) must provide the information separately. For serial-numbered used equipment, this is in effect a unit-by-unit list, and the workload grows linearly with the number of units.

Insight 3: Article 9-1.9.6 requires manufacturer quality indicator results confirming conformity of each consignment with its specifications. Used equipment can hardly provide quality indicator results from the time of manufacture; in practice a document on the current-state test or calibration results is usually issued by the manufacturer or a service provider (practical estimate: the Rules do not elaborate; follow the AEC requirements). This is the largest documentary bottleneck in used equipment projects.

Insight 4: One permit per consignment is particularly demanding for used equipment. Under Article 9-1.2, a single consignment means one permit per unit for a single large machine. Whether several identical units imported at the same time can be applied for as one consignment depends on the AEC’s determination of what constitutes a consignment (pending verification: written confirmation before shipment is recommended).

Insight 5: Used devices must still satisfy the general requirement of Article 6.1. Except in the statutory cases, unregistered products may not be imported. Where used equipment falls within the registrable range (medium, high or higher risk), national registration must be completed first, followed by the import permit; being used is not a ground for exemption from registration.

4. Practical recommendations

1. At the start of a used equipment project, confirm whether the usability document issued by the manufacturer and the current-state test or calibration results can be obtained.
2. Prepare the per-consignment document pack on the basis of the 7 items of Article 9-1.9 plus the additional item of Article 9-1.10, with the unit-by-unit list as a separate annex.
3. For used equipment in the registrable range, complete national registration first (including the usability document under paragraph 4.2.11), then obtain the import permit.
4. Confirm in writing with the AEC before shipment whether several identical units can be applied for as one consignment.
5. Where the usability document is issued by the seller, confirm with the AEC first whether it is accepted.
6. Write the obtaining of manufacturer documents into the contract as a condition precedent and a precondition of the quotation.

5. Verification checklist

• □ The availability of the manufacturer usability document and current-state test or calibration results has been confirmed.
• □ The per-consignment document pack for used equipment has been prepared on the basis of 7 plus 1 items.
• □ Registrable used equipment has completed national registration first.
• □ The consignment determination for multiple units has been confirmed in writing with the AEC.
• □ The acceptability of usability documents issued by the seller has been confirmed.
• □ The contract includes the obtaining of manufacturer documents as a condition precedent.

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.