Azerbaijan Medical Device Import Permit: One Permit per Consignment and 7 Supporting Documents

1. Key takeaways

The import permit system for devices in Azerbaijan is set out in Article 9-1 of the Law on Medicinal Products, with four key points:

9-1.2 The import permit is issued for goods imported in the form of a single consignment and is valid only for that consignment (one permit per consignment);

9-1.4 The applicant must file the application with the issuing authority before the goods enter the customs territory of Azerbaijan;

9-1.9 When importing devices, the application must be accompanied by 7 documents (an extract from the state register of legal entities or an identity document; evidence of taxpayer registration; evidence of ownership or lease of the warehouse premises; a notarized copy of the sale contract with a notarized Azerbaijani translation; copies of paper and electronic invoices; manufacturer quality indicator results confirming conformity of each consignment with its specifications; and a certificate of origin);

9-1.12 Review periods: for medicinal products and pharmacologically active substances, 23 working days based on the expert assessment or 13 working days under the simplified assessment; for devices, the period is the one prescribed by Article 19.9 of the Law on Licenses and Permits. Article 19.9 provides that, unless a shorter period is prescribed by another law other than the Law on Administrative Procedure, the license or permit is issued, or an administrative decision on refusal is taken, no later than 7 working days from the registration of the application.

Paragraph 9-1.3 further provides that Article 9-1 does not apply to the medicinal products listed in Articles 6.5.4, 6.5.6, 6.5.9, 9.2, 9.3 and 9.6, nor to import situations carried out by bodies (institutions) determined by the relevant executive authority.

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): Article 9-1.1 (issuance, duplicates, reissuance, suspension, resumption and revocation of the import permit follow the Law on Licenses and Permits and the Law on Administrative Procedure), Article 9-1.2 (one permit per consignment), Article 9-1.3 (exclusions), Article 9-1.4 (application before entry into the customs territory), Articles 9-1.9.1 to 9-1.9.7 (seven documents for device import), Article 9-1.12 (period for devices follows Article 19.9 of the Law on Licenses and Permits), Article 6.1 (unregistered products may not be imported), Article 9-1.11 (application of the requirements of Articles 6-2.3 and 6-2.5 to 6-2.9 during review).
• 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), Article 19.11 (issuance within 2 working days of submission of proof of payment), Articles 18.2.1 to 18.2.3 (documents on legal entity status).
• Law of the Republic of Azerbaijan on Administrative Procedure, Article 31 (acceptance and registration of applications) and Article 52 (remedying of deficiencies).

3. Expert insights

Insight 1: One permit per consignment is the real operating cost of importing devices. The combination in Article 9-1.2 of goods imported in the form of a single consignment and valid only for that consignment means every consignment requires a new permit application, with all 7 documents prepared again for each one; the notarized copy of the sale contract, the invoices, the per-consignment quality indicator results and the certificate of origin must be refreshed every time. Channel cost models must therefore be built on the number of consignments.

Insight 2: Article 9-1.4 locks the application point to before customs entry. The application must be filed before the goods enter the customs territory of Azerbaijan. Combined with the 7-working-day review period in Article 9-1.12, this means in practice: reserve at least 7 working days plus document preparation time before shipment, otherwise the goods cannot be cleared even after arrival at port.

Insight 3: Article 9-1.9.3 requires evidence of ownership or lease of the storage premises. This is a substantive threshold for foreign manufacturers without local warehousing — it is necessary to prove the availability in Azerbaijan of a warehouse or premises usable for carrying out the import, held under ownership, usage right or lease. It also indicates indirectly that the applicant for an import permit is typically an entity with physical business premises in Azerbaijan.

Insight 4: Article 9-1.9.5 imposes a high information density on invoices. Where the invoice does not state them, information issued by the manufacturer (seller) stating the full name, serial numbers and use-by or expiry dates of the imported devices must additionally be provided. Together with Article 9-1.9.6 (manufacturer quality indicator results confirming conformity of each consignment with its specifications), this in effect requires a batch-traceable quality file for every consignment.

Insight 5: There is a textual tension between Article 9-1.11 and Article 1-1 similar to that surrounding Article 9-1 itself. Article 9-1.11 provides that the requirements of Articles 6-2.3 and 6-2.5 to 6-2.9 apply when reviewing import permit applications, while Article 1-1 of the Law places Article 6-2 on the list of provisions not applicable to devices. Practical estimate: follow the operational requirements published by the AEC and confirm in writing with the AEC; do not assert on your own that the provisions do not apply.

4. Practical recommendations

1. Build the import budget on the basis of number of consignments multiplied by cost per consignment; do not amortize one permit across a year.
2. Reserve at least the 7-working-day review period plus document preparation time before shipment, and complete the application before the goods reach port (Article 9-1.4).
3. Secure warehousing premises in Azerbaijan in advance and obtain the evidence of ownership or lease (Article 9-1.9.3).
4. Prepare the per-consignment quality file (manufacturer quality indicator results, serial numbers, use-by or expiry dates) together with the invoice for each consignment.
5. Where the sale contract is in a foreign language, prepare a notarized Azerbaijani translation at the same time (Article 9-1.9.4).
6. Confirm in writing with the AEC the operational treatment of the tension between Article 9-1.11 and Article 1-1.

5. Verification checklist

• □ The import budget has been built on the number of consignments.
• □ The shipping schedule reserves the 7-working-day review period.
• □ Warehousing premises have been secured with evidence of ownership or lease.
• □ The per-consignment quality file (quality indicator results, serial numbers, expiry dates) has been templated.
• □ The notarized Azerbaijani translation of foreign-language sale contracts is included in the per-consignment document pack.
• □ The tension between Article 9-1.11 and Article 1-1 has been confirmed in writing with the AEC.

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.