Azerbaijan Medical Device Registration 2026: Usability Document for Used Devices

1. Key takeaways

Article 4.2.11 requires that, for devices that have already been used (second-hand devices), a copy of the usability document for the device issued by the manufacturer be submitted. This is the last item of the eleven-item dossier and the only clause addressed to the special status of being second-hand.

On the import side, Article 9-1.10 of the Law on Medicinal Products contains a matching provision: when importing devices that have already been used, the documents under Article 9-1.9 must be accompanied by a copy of the usability document for the device issued by the manufacturer (seller). In other words, a second-hand device must be supported by the usability document both at registration and at import. Because the wording differs slightly between the two stages, the document set must be planned once and reused consistently.

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 4.2.11 (usability document for used devices), Article 4.2 (eleven-item dossier), Article 4.3 (the list of exemptions does not include 4.2.11), Article 2.1.1 (definition of the applicant).
• 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 9-1.9 (seven documents for an application to import devices), Article 9-1.10 (additional usability document for the import of used devices), Article 9-1.2 (one import permit per consignment), Article 6.1 (unregistered devices may not be imported, manufactured, sold or used).
• 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 2.1.4 (definition of accessories), Article 7.10 (accessories registered together with the complete set).

3. Expert insights

Insight 1: Article 4.2.11 has no exemption, and its condition of application is already used, not already registered. None of the three exemptions of Article 4.3 touches 4.2.11. The condition of the clause is istifadə edilmiş tibb vasitələrinə münasibətdə (with respect to devices that have been used), which refers to the second-hand state of the device, not to whether it has been registered in another country. Refurbished units, demonstration units sold after exhibitions, and equipment returned from leases can all fall within this clause.

Insight 2: One copy at registration and one at import is a double document burden for second-hand devices. Article 4.2.11 (registration dossier) and Article 9-1.10 (import application) both require a copy of the usability document, but the wording on the issuing party differs slightly: at registration it is issued by the manufacturer, and at import it is issued by the manufacturer (seller). Practical estimate: prepare originals issued by the manufacturer, and where the import stage document is issued by the seller, confirm in advance whether it will be accepted (pending verification).

Insight 3: The substantive content of the usability document is not detailed in the Rules. The clause speaks only of the usability document (istifadəyə yararlılığına dair sənəd) and does not prescribe what it must state. Practical estimate: it is advisable to include the identification of the device (model and serial number), the duration or condition of prior use, maintenance and calibration records, an assessment of remaining useful life, and the conclusion of the manufacturer that the device can still be used for its intended purpose. The specific expectations of the AEC prevail.

Insight 4: A second-hand device must still pass through the complete eleven-item dossier. Article 4.2.11 is an additional item, not a substitute. A used device does not benefit from any reduction of items 4.2.1 to 4.2.10 merely because it has been used, in particular 4.2.1 (manufacturing right) and 4.2.9 (QMS certificate); even where the device has been out of production for years, the original manufacturer must be found to issue or supply the historical documents. This is the largest feasibility risk in any second-hand device project.

4. Practical recommendations

1. At project launch, first confirm whether the usability document can be obtained from the original manufacturer; where it cannot, assess project feasibility before quoting.
2. Have the usability document issued by the manufacturer and state the model, serial number, condition of use, maintenance and calibration records, remaining life assessment and the usability conclusion.
3. Prepare a copy for the registration stage and a copy for the import stage; where the import document is issued by the seller, confirm with the AEC in writing first.
4. Prepare second-hand devices against the complete eleven-item dossier, with no reduction of items because the device has been used.
5. Treat refurbished units, demonstration units sold after exhibitions and equipment returned from leases as second-hand devices in all cases.
6. Write the obtainability of the manufacturer documents into the contract as a condition precedent, to avoid the shipment stalling midway.

5. Verification checklist

• □ It has been confirmed that the usability document can be obtained from the original manufacturer.
• □ The usability document states the model, serial number, condition, maintenance records and the usability conclusion.
• □ A copy has been prepared for each of the registration and import stages (Article 4.2.11 and Article 9-1.10).
• □ Where the import document is issued by the seller, written confirmation from the AEC has been obtained.
• □ The second-hand device has been prepared against the complete eleven-item dossier.
• □ The contract includes obtaining the manufacturer documents as a condition precedent.

Related reading: Dossier of Eleven Items: Breakdown of 4.2.1 to 4.2.11 (https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/); Three Documents under Articles 18.2.1 to 18.2.3 of the Law on Licences and Permits (https://www.grzanglobal.com/azerbaijan-medical-device-registration/licenses-and-permits-law-18-2-documents/); Additional Import Documents for Used Devices (https://www.grzanglobal.com/azerbaijan-medical-device-registration/additional-import-documents-used-devices/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, second-hand device imports, usability documentation and import permit filings. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.