Azerbaijan Low Risk Medical Devices: Registration Exemption and Import Permit Rules

1. Key takeaways

Low risk (Class 1) medical devices are not subject to state registration in Azerbaijan. Article 3.4 of Decision No. 8 brings only the three degrees of higher, high and (or) medium within the state registration defined in Article 1.0.8 of the Law on Medicinal Products, and Article 1.2.3 of the Resolution No. 345 Rules likewise lists only those three degrees. But low risk does not mean nothing to do: import still requires an import permit for each consignment under Article 9-1 of the Law on Medicinal Products, and Article 9-1.2 limits the permit by providing that it is issued for one consignment of goods and is valid only for that consignment.

Article 6.5 adds a separate list of exemptions, in which Article 6.5.1 expressly states that medicinal products and medical devices intended to be exhibited at exhibitions (exhibition samples) do not require state registration. That list is another lawful gateway to non-registration, but note that it exempts registration, not import formalities. Exhibition samples still go through the temporary import application under Article 9-1.7.

2. Legal basis

• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan of May 21, 2024, on the Classification of Medical Devices by Risk Degree (adopted under the second sentence of Article 6.8 of the Law on Medicinal Products; signed by Minister Teymur Musayev; sent to the Ministry of Justice for entry into the national register of legal acts within 3 days of adoption): Article 3.3 (4 degrees) and Article 3.4 (registration only for the higher, high and medium degrees).
• 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 1.0.8 (definition of state registration and the device scope), Article 6.1 (no import, domestic manufacture, sale or use without state registration except in statutory cases), Article 6.5 (cases not requiring state registration, including 6.5.1 exhibition samples), Article 9-1.2 (one import permit per consignment), Article 9-1.9 (application documents for device imports).
• 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 1.2.3 (the scope of devices subject to registration).

3. Expert insights

Insight 1: what is exempted is registration, not oversight. Article 1.2.3 and Article 3.4 merely remove low risk devices from the state registration list, while the general prohibition in Article 6.1 remains that import, domestic manufacture, sale and use are allowed only after state registration by the issuing authority, except in the cases provided by the law. Low risk devices get through because they are simply not within the scope that must be registered, not because they hold any inspection-free pass.

Insight 2: one permit per consignment is where the real cost of low risk devices sits. Article 9-1.2 provides that the import permit is issued for goods imported in the form of one consignment and is valid only for that consignment. For high-volume, low-value consumables this means a fresh permit application for every single consignment, with the document package under Article 9-1.9, which has 7 items, rebuilt each time. Budget on the basis of number of consignments multiplied by the per-consignment cost, not on the basis of one annual filing.

Insight 3: the exemption list of Article 6.5 deserves an item-by-item comparison. Besides Article 6.5.1 on exhibition samples, the list includes: Article 6.5.3 (imports during epidemics, natural disasters and other emergencies), Article 6.5.4 (products for scientific research, preclinical studies and clinical trials, subject to a decision of the relevant executive authority), Article 6.5.5 (samples imported for registration purposes in the statutory quantities and procedure, together with the drug substances used in them), Article 6.5.6 (reasonable quantities for personal use), and Article 6.5.9 (use by athletes and accompanying staff of participating countries during international or regional sports events). Projects involving emergency aid, clinical trials and prototype imports can use these provisions directly.

Insight 4: the exemptions of Article 4.3 are a different thing from low risk. Article 4.3 of the Resolution No. 345 Rules exempts certain dossier items for devices that are already determined to be registrable (domestic production is exempt from 4.2.1, 4.2.2, 4.2.8 and 4.2.9; IVDs are exempt from 4.2.5; devices not contacting the human body are exempt from 4.2.6). Do not confuse this with the non-registration of low risk devices: the former is a document reduction, the latter is a route exemption.

4. Practical recommendations

1. When initiating a low risk device project, prepare the budget on the basis of the number of consignments multiplied by the per-consignment import permit cost, not as a one-off annual amount.
2. Before each import, rebuild the document package once under the 7 items of Article 9-1.9; the notarized copy of the sale contract and the invoice are replaced with every consignment.
3. For exhibition units, trial devices and emergency aid goods, first find the matching item in the Article 6.5 list and then decide which channel to use.
4. Manage the dossier exemptions of Article 4.3 separately from the non-registration of low risk devices: record the former in the dossier checklist and the latter in the route determination table.
5. When explaining to clients, make clear that low risk is a local Azerbaijani classification conclusion, not a manufacturer self-declaration, and must be supported by a classification statement.
6. Archive each approved import permit after use, as part of the circulation evidence chain for later registration or audit work.

5. Verification checklist

• □ Confirmed under Articles 3.3 and 3.4 of Decision No. 8 that the product is low risk and does not require state registration.
• □ Confirmed that imports still require an import permit per consignment under Article 9-1.
• □ Built a single-consignment document package template based on the 7 items of Article 9-1.9.
• □ Compared the exemption list of Article 6.5 and confirmed that no exemption item applies directly.
• □ Distinguished between non-registration of low risk devices and the dossier exemptions of Article 4.3.
• □ Built a consignment-by-consignment ledger of import permits.

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 12. Classification Determination Before Submission: How to Use the Grading Rules of Decision No. 8: https://www.grzanglobal.com/azerbaijan-medical-device-registration/classification-determination-before-submission/
• Article 37. Import Permits: One Permit per Consignment and 7 Working Days: https://www.grzanglobal.com/azerbaijan-medical-device-registration/import-permit-one-per-consignment/

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.