Azerbaijan Medical Device Classification: Determining the Risk Degree Before Submission

1. Key takeaways

The most important step before submission is the classification determination: it decides whether a product requires state registration at all, and which pathway applies. Decision No. 8 is structured as follows: Section 3 sets out the determination dimensions and the 4 risk degrees, Section 4 governs invasive devices, Section 5 non-invasive devices, Section 6 active devices (including software), Section 7 in vitro diagnostic devices, and Section 8 contains supplementary provisions (devices incorporating a medicinal substance, contraception and sexually transmitted disease protection, contact lens care, disinfection and sterilisation, X-ray imaging, tissues of animal and human origin, nanomaterials, inhalation administration, absorbable substances, closed-loop systems and automated external defibrillators).

The recommended determination sequence runs through six steps: intended purpose, then invasiveness, then duration of use, then contact with critical organs, then active status, then special materials. Each step maps to a specific provision of Decision No. 8, so the reasoning can be documented clause by clause.

Because only degree three devices fall within the registration scope, the determination is not academic: it is the gate that decides whether the entire Registration Rules machinery applies to the product, and it feeds directly into register and certificate fields downstream.

2. Legal basis

• Decision No. 8 of the Collegium of the Ministry of Health of the Republic of Azerbaijan dated 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; submitted to the Ministry of Justice for inclusion in the Register of Legal Acts within 3 days of adoption): Article 3.1 (8 determination dimensions), Article 3.2 (assignment to exactly one degree), Article 3.3 (4 degrees), Article 3.4 (only degree three requires registration), Article 3.5 (three duration groups), Article 3.8 (accessories classified separately), Part 4 (invasive), Part 5 (non-invasive), Part 6 (active and software), Part 7 (IVD), Part 8 (supplementary provisions).
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated 18 July 2024 on the Rules for State Registration of Medicines, Drug Substances and Medical Devices, Their Entry into the State Register and Maintenance of the State Register (effective 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Bulletin 2024 No. 7, item 906; repealing Resolution No. 108 of 13 July 2007 as of 20 July 2024): Article 1.2.3 (registration scope), Article 4.3 (dossier exemptions), Article 7.10 (accessories registered with the set).
• Law of the Republic of Azerbaijan on Medicines (Law No. 208-IIIQ, adopted 22 December 2006, effective 28 February 2007, Legislative Bulletin 2007 No. 2, item 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1 with new wording, Legislative Bulletin 2023 No. 8, item 1127) — the source of the classification competence.

3. Expert insights

Insight one: Article 5.6 splits non-invasive devices contacting broken skin or mucous membranes into four tiers, and this is the most frequently used entry point. Devices used as a mechanical barrier, for compression or for absorbing exudates are low degree (5.6.1); those used to breach the dermis or mucous membrane and which can only heal by secondary intent are high degree (5.6.2); those principally intended to manage the micro-environment of broken skin or mucous membranes are medium degree (5.6.3); other cases are medium degree (5.6.4). Wound dressing classifications almost always land here.

Insight two: Articles 5.1 to 5.4 give conduit and storage devices a clear up-and-down logic. Non-invasive devices for channelling or storing blood, body liquids, cells or tissues, liquids or gases for eventual infusion into the body (blood bags excepted) are medium degree where they may be connected to an active device in degree IIa, IIb or higher (5.1.1) or where intended for preserving organs, organ parts, cells or tissues of human origin (5.1.2); otherwise they are low degree (5.2); blood bags are high degree (5.3). Devices intended to alter the biological or chemical composition of human tissues or cells (including blood), body liquids or other liquids for infusion or implantation are high degree unless the treatment is filtration, centrifugation or exchange of gas or heat, in which case they are medium degree (5.4).

Insight three: IVD classification is a self-contained rule set and the invasive-device logic cannot be transplanted onto it. Article 7.3 lists as higher degree the assessment of suitability for transfusion, transplantation or cell administration (including testing for transmissible agents), testing for agents with a high risk of transmission and lethal infection, and monitoring of infectious load in lethal diseases. Article 7.4 splits blood grouping and tissue typing markers (ABO, Rh, Kell, Kidd, Duffy) between high and higher. Article 7.5 lists 13 high degree situations, including sexually transmitted agents, pathogens in cerebrospinal fluid or blood, cancer screening, diagnosis and staging, human genetic testing and neonatal screening for congenital anomalies. Article 7.6 places self-tests (pregnancy, fertility, cholesterol, bacteria, glucose, erythrocytes and leukocytes in urine) at medium; Article 7.7 places general laboratory products, accessories without critical characteristics, buffer and wash solutions, general culture media and histological stains, instruments and specimen containers at low; Article 7.8 is the catch-all at medium.

Insight four: the classification conclusion must feed the register and certificate fields in reverse. Article 10.4.3 of Registration Rules No. 345 requires the register to record the risk degree, and the Annex 5 certificate also displays the risk degree. The classification rationale is not an internal document; it will ultimately appear on public-facing fields, so any vagueness resurfaces there.

4. Practical recommendations

1. Run the six-step determination (purpose, invasiveness, duration, critical organs, active status, special materials) and document each step.
2. For dressings check the four tiers of Article 5.6 first; for conduits and reservoirs check Articles 5.1 to 5.4; for IVD go straight to Section 7.
3. In the classification rationale, cite the exact article of Decision No. 8 for each situation; one situation, one clause, no vague wording.
4. Reconcile the classification conclusion with Article 10.4.3 of the register rules and the certificate risk-degree field before submission.
5. For large portfolios, build a classification matrix per SKU to avoid inconsistent degrees within one family.
6. Where a classification is doubtful, ask AEC in writing first; never rely on the argument that a similar product was registered that way.

5. Verification checklist

• □ The six-step determination is complete and documented step by step.
• □ The classification rationale cites the specific articles of Decision No. 8 relied upon.
• □ The conclusion matches Article 10.4.3 of the register rules and the certificate risk-degree field.
• □ Dressings, conduits, IVD and software categories have been routed to their dedicated provisions.
• □ Multi-SKU portfolios have a classification matrix with consistency reviewed.
• □ Doubtful classifications have been raised with AEC in writing and the replies archived.

• Article 05 — The four risk degrees: low, medium, high and higher (classes 1, 2a, 2b, 3): https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-risk-degrees-class-1-2a-2b-3/
• Article 13 — The 11 dossier items one by one: 4.2.1 to 4.2.11: https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/
• Article 17 — IVD-specific requirements: Section 7 of the classification decision and the exemption rule: https://www.grzanglobal.com/azerbaijan-medical-device-registration/ivd-specific-requirements/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in preparing classification rationales and pre-submission determinations for medical devices in Azerbaijan, mapping products against Decision No. 8 and reconciling risk degrees with register and certificate fields. For tailored assistance with your Azerbaijan medical device classification, contact us at info@grzanglobal.com.