Azerbaijan Medical Device Import Without Registration: Prohibition, Exemptions and Consequences

1. Key takeaways

Article 6.1 of the Law on Medicines is a prohibitory provision: except in the cases provided by that law, the import of medicines and devices into Azerbaijan, their domestic production, sale and use are permitted only after State registration by the competent issuing authority. Article 1.6 of Rules No. 345 states the same rule affirmatively: import, domestic production, sale and use become permissible only after entry in the State Register.

There are only two lawful routes to enter without registration: first, a product outside the registration-required scope of Article 1.2.3 (that is, low-risk devices under Article 3.4 of Decision No. 8); second, one of the no-registration situations of Article 6.5 (exhibition samples, imports under a state of emergency, scientific research and clinical trials, samples for registration purposes, personal use, WHO recommendations, medicines for rare diseases, medicines for sporting events).

Even on these two routes, an import permit under Article 9-1 is still required at the import stage (Article 9-1.2, one permit per consignment).

2. Legal basis

• Law of the Republic of Azerbaijan on Medicines (No. 208-IIIQ, adopted 22 December 2006, in force 28 February 2007, Legislative Collection 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, Article 1127): Article 6.1 (no import, production, sale or use without registration), Articles 6.5.1 to 6.5.9 (nine situations exempt from State registration), Article 9-1.2 (one permit per consignment), Article 9-1.4 (application before customs entry), Article 9-1.9 (7 documents for device imports), Article 9-1.12 (review period).
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of 18 July 2024 approving the Rules for the State Registration of Medicines, Pharmaceutical Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (in force from 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Collection 2024, No. 7, Article 906; repealing Resolution No. 108 of 13 July 2007 with effect from 20 July 2024): Article 1.2.3 (the device scope requiring registration), Article 1.6 (the four permissions after entry), Article 11.2 (full-chain stop after suspension), Articles 10.6 and 10.7 (Register entries and publication).
• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of 21 May 2024 on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicines; signed by Minister Teymur Musayev; to be sent to the Ministry of Justice for inclusion in the National Register of Legal Acts within 3 days of adoption): Article 3.4 (low-risk devices are not registered).

3. Expert insights

Insight one: Article 6.1 governs four actions, not only import. Import into the country, domestic production, sale and use all fall within the prohibition. This means local contract manufacturing, local assembly, post-exhibition resale and even use by healthcare institutions are all premised on State registration. Every commercial step a company takes in Azerbaijan must first pass this provision.

Insight two: among the nine exemptions of Article 6.5, those devices can mainly rely on are 6.5.1, 6.5.3, 6.5.4 and 6.5.5. Exemption 6.5.1 (exhibition samples) expressly names medicines and medical devices; exemptions 6.5.3 (imports during epidemics, natural disasters and other states of emergency), 6.5.4 (scientific research, preclinical studies and clinical trials, subject to a decision of the relevant executive authority) and 6.5.5 (samples imported for registration purposes in the statutory quantities and procedure) are worded for medicines, but Article 1-1 does not exclude Article 6.5 as a whole. Practical estimate: whether a device can invoke them should be confirmed with the AEC in writing.

Insight three: low-risk exemption from registration does not mean no formalities. Article 3.4 exempts low-risk devices from State registration, but the import permit of Article 9-1 still applies, with one permit per consignment. The statement that no registration is needed is only half right; the complete statement is that no State registration is needed, but a consignment-by-consignment import permit and the full import document set are still required.

Insight four: the consequences of breach lie in the Register and the recall rules, not in penalty provisions. Within the official texts verified for this series, Article 6.1 is a prohibitory provision and Parts 11 and 12 address suspension and revocation of registered products. The specific administrative or criminal liability provisions for importing without registration are outside the verification scope of this series and remain a practical estimate pending verification; local counsel should be consulted on a case-by-case basis.

Insight five: the publicity of the Register makes violations hard to hide. Article 10.7 requires the Register data to be published on the official websites of the Ministry of Health and the AEC. Distributors, tender committees and competitors can all verify from the public Register whether a product is registered and whether it stands suspended or revoked. Selling first and registering later carries a higher risk in Azerbaijan than in many markets.

4. Practical recommendations

1. Before any commercial action (import, local production, sale, use), confirm whether the product requires State registration.
2. For exemption routes, locate the specific item within Article 6.5 first and obtain written AEC confirmation that a device can invoke it.
3. Operate low-risk devices on the basis of exemption from registration plus a consignment-by-consignment import permit, preparing the document set of the 7 items of Article 9-1.9.
4. Do not sell first and register later: the Register is publicly searchable and a non-compliant status will be seen by distributors and tender committees.
5. Liability provisions for unregistered imports fall outside the verification scope of this series; consult local counsel on each case.
6. Write a registration-status warranty clause into distribution agreements, making clear that unregistered products must not be placed on the market.

5. Verification checklist

• □ The registration requirement for every commercial action has been confirmed.
• □ Exemption routes have been located within Article 6.5 and confirmed with the AEC.
• □ Low-risk devices are operated on the exemption-plus-import-permit basis.
• □ A no-sale-before-registration policy has been set explicitly.
• □ Local counsel consultation has been arranged for unregistered import liability questions.
• □ Distribution agreements contain a registration-status warranty clause.

• Article 06 — Low-risk devices without registration: the exemption boundary and the import permit: https://www.grzanglobal.com/azerbaijan-medical-device-registration/low-risk-devices-exemption-and-import-permit/
• Article 37 — The import permit: one permit per consignment and 7 working days: https://www.grzanglobal.com/azerbaijan-medical-device-registration/import-permit-one-per-consignment/
• Article 42 — Suspension of State registration: 4 grounds and a full stop on import, sale and use: https://www.grzanglobal.com/azerbaijan-medical-device-registration/suspension-of-state-registration/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and post-market compliance documentation for the Azerbaijan market, from registration scope analysis and exemption confirmations to import permit document sets under Article 9-1.9. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.