Azerbaijan IVD Requirements: Section 7 Classification Rules and the Article 4.3 Exemption

1. Key takeaways

In vitro diagnostic devices (IVDs) in Azerbaijan are governed by a separate classification rule set: Articles 2.1.5 to 2.1.7 of Decision No. 8 define in vitro, IVD devices and specimen containers, and Section 7 provides the classification rules; meanwhile Article 4.3 of Registration Rules No. 345 grants one exemption — Article 4.2.5 (medicinal substance information) does not apply to devices that obtain information by examining human samples in a test tube, that is, IVDs.

On classification, IVDs fall outside the 4-degree formulation of Article 3.3 that applies to non-IVD devices and follow the dedicated rules of Section 7: Article 7.3 is higher degree; Article 7.4 splits blood grouping and tissue typing markers between high and higher; Article 7.5 lists 13 high degree situations; Article 7.6 places self-tests at medium; Article 7.7 places general laboratory products and specimen containers at low; Article 7.8 is the catch-all at medium.

The dual consequence is that IVD sponsors must read two instruments in parallel: the classification decision for their risk degree, and the registration rules for which dossier items actually apply to them.

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 within 3 days): Article 2.1.5 (definition of in vitro), Article 2.1.6 (definition of IVD device), Article 2.1.7 (definition of specimen container), Article 7.1 (calibrators share the degree of the device), Article 7.2 (control materials share the degree of the device), Article 7.3 (higher degree: transmissible agents, high-risk lethal pathogens, infectious load in lethal diseases), Article 7.4 (blood grouping and tissue typing markers), Articles 7.5.1 to 7.5.13 (high degree: sexually transmitted agents, pathogens in cerebrospinal fluid or blood, cancer screening, diagnosis and staging, human genetic testing, prenatal screening, neonatal screening for congenital anomalies and the other 13 situations), Article 7.6 (self-tests at medium), Articles 7.7.1 to 7.7.3 (low degree: general laboratory products, instruments, specimen containers), Article 7.8 (others at medium).
• 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 4.3 (Article 4.2.5 not applicable to IVDs), Article 1.2.3 (registration scope).

3. Expert insights

Insight one: the IVD definition expressly includes software systems. Article 2.1.6 covers reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or software systems. This runs in parallel with the software classification rules of Articles 6.10 to 6.14: IVD software follows the purpose-based rules of Section 7, while standalone non-IVD software follows Articles 6.10 to 6.14. Choosing the wrong section shifts the degree by one tier.

Insight two: the companion-degree rules of Articles 7.1 and 7.2 simplify combined submissions. Calibrators intended for use with a specific device share the degree of that device; control materials with stated quantitative and qualitative values for one or more analytes likewise share the degree of the corresponding device. When submitting reagent-plus-calibrator-plus-control sets, no separate classification exercise is needed for the companions.

Insight three: the low-degree list of Article 7.7 is a registration-free channel for many laboratory consumables. General laboratory products, IVD accessories without critical characteristics, buffer and wash solutions, general culture media and histological stains, instruments and specimen containers are all low degree and fall outside the registration scope of Article 3.4. This is precisely why Article 2.1.7 defines specimen containers separately — to make clear they are devices but sit at the low tier.

Insight four: the high-degree list of Article 7.5 is extremely broad, and IVD companies must not assume they are medium degree. Testing for sexually transmitted agents (7.5.1), infectious agents in cerebrospinal fluid or blood (7.5.2), cancer screening, diagnosis and staging (7.5.8), human genetic testing (7.5.9), prenatal screening (7.5.4) and neonatal screening for congenital anomalies (7.5.13) are among the 13 high degree situations. Most oncology and infectious-disease reagents land here.

Insight five: the Article 4.3 exemption removes only item 4.2.5. IVDs are exempt from medicinal substance information, but items such as 4.2.6 (biosafety) and 4.2.7 (sterility, where supplied sterile) remain in force. Being an IVD is not a blanket dossier reduction.

4. Practical recommendations

1. Determine IVD status under Article 2.1.6 first, then choose Section 7 or Sections 4 to 6; IVD software goes to Section 7.
2. Classify sets (reagents plus calibrators plus controls) with the main device under Articles 7.1 and 7.2; do not classify companions separately.
3. Screen the portfolio item by item against the 13 high-degree situations of Article 7.5; never default to medium.
4. Confirm the low degree for general laboratory consumables and specimen containers under Article 7.7 and record the exemption judgement in writing.
5. Mark only item 4.2.5 as exempt on the dossier checklist under Article 4.3; submit everything else as normal.
6. Reconcile the classification conclusion with Article 10.4.3 of the register rules and the certificate risk-degree field.

5. Verification checklist

• □ IVD status is confirmed under Article 2.1.6 and the classification section selected.
• □ IVD classification is completed under Articles 7.3 to 7.8.
• □ Calibrators and controls in sets are classified with the main device under Articles 7.1 and 7.2.
• □ The 13-item list of Article 7.5 has been screened clause by clause.
• □ Low-degree consumables have a written exemption judgement under Article 7.7.
• □ Only item 4.2.5 is marked exempt on the dossier checklist.

• Article 12 — Classification determination before submission: how to use the Decision No. 8 rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/classification-determination-before-submission/
• 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 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/

Regulatory information verified as of October 30, 2026.

GRZAN supports IVD manufacturers in applying Section 7 of Decision No. 8 and the Article 4.3 exemption for in vitro diagnostic devices in Azerbaijan, from companion-degree grouping and high-degree screening to register field reconciliation. For tailored assistance with your Azerbaijan IVD registration, contact us at info@grzanglobal.com.