Azerbaijan Medical Device Registration 2026: Biosafety Information and When It Can Be Exempted

1. Key takeaways

Article 4.2.6 requires the biosafety information provided by the manufacturer, while Article 4.3 provides that this item does not apply to devices that do not come into contact with the human body when used. Of the three exemptions in Article 4.3, this is the easiest to judge and also the most frequently misapplied one.

The test is whether the device comes into contact with the human body when used (insanın bədəni ilə təmasda olmayan tibb vasitələri). This test is closely related to Article 3.1.5 of Decision No. 8 (contact or interaction with human tissues or organs), but the two serve different purposes: Article 3.1.5 is used for classification, while Article 4.3 is used for exemption from a dossier item. A device may therefore be exempt from the biosafety documents yet still be classified with reference to the contact dimension.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Article 4.2.6 (biosafety information), Article 4.2.7 (additional documents for sterile devices), Article 4.3 (4.2.6 does not apply to devices that do not contact the human body), Article 5.1.4 (inconsistent documents are a ground for rejection).
• 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 within 3 days of adoption for entry in the register of legal acts): Article 3.1.5 (contact or interaction with human tissues or organs), Article 5.6 (classification of non-invasive devices contacting injured skin or mucous membranes), Articles 8.7 and 8.8 (products manufactured from human or animal tissues or cells).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında), No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Compilation 2007, No. 2, item 70, as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 with new wording, Legislative Compilation 2023, No. 8, item 1127): Article 1.0.14 (definition of the quality of a device).

3. Expert insights

Insight 1: What is exempted is the document, not the assessment. Article 4.3 removes the obligation to submit biosafety information, but it does not make biosafety irrelevant. Article 3.1.5 of Decision No. 8 still lists contact or interaction with human tissues or organs as a classification dimension, and Article 5.1.4 still permits rejection where inconsistencies related to safety are found in the documents. The conclusion should first be assessed and recorded in the classification rationale document, and only then should the decision on submitting the information be made.

Insight 2: The judgement of no contact with the human body must be made at concrete steps of use. Many devices do not touch the human body during their principal use but do so during cleaning, calibration or sampling. For example, an in vitro diagnostic instrument itself never enters the human body, but its sampling consumables do; imaging equipment does not touch the patient, but coupling gel or positioning pads do. Judge by the least favourable step of use, not by the main function, and document the reasoning for each step evaluated.

Insight 3: Article 4.2.6 and Article 4.2.7 are two independent lines and cannot replace each other. Item 4.2.6 is biosafety information (exempt where there is no contact with the human body), and 4.2.7 is additional documentation for sterile devices (with no such exemption). A device that is both sterile and body-contacting requires both; a device that is sterile but non-contacting, such as certain sterile-packaged in vitro consumables, may be exempt from 4.2.6 but still requires 4.2.7.

Insight 4: Articles 8.7 and 8.8 add a further step up for materials of biological origin. Devices manufactured using devitalised or inactivated human or animal tissues, cells or their derivatives are classified in the highest degree (8.7), and products of animal origin that only contact intact skin are classified in the high degree (8.8). Such products both contact the human body and are of biological origin, so the requirements under 4.2.6 are the heaviest, and the biological evaluation is usually prepared following the approach of the ISO 10993 series (practical estimate: the Rules do not name a specific standard; follow the requirements of the AEC).

4. Practical recommendations

1. Judge contact with the human body by the least favourable step of use, and record the conclusion in the classification rationale document.
2. Where the conclusion is no contact, invoke the exemption of Article 4.3 for item 4.2.6 in the covering letter and state the basis of the judgement.
3. For body-contacting devices, compile the biosafety documentation and the sterile documentation under 4.2.7 into separate volumes, each marked with its clause number.
4. Reassess the risk degree for materials of biological origin under Articles 8.7 and 8.8, and do not treat them as ordinary contact devices.
5. Keep the biological statements consistent with the other documents (4.2.3 and 4.2.8) to avoid triggering Article 5.1.4.
6. Because the Rules do not name a specific biological evaluation standard, apply the practical estimate of following the AEC dossier requirements and retain written confirmation.

5. Verification checklist

• □ Contact with the human body has been judged by the least favourable step of use.
• □ The conclusion has been recorded in the classification rationale document with the clause basis noted.
• □ The exemption situation has been invoked under Article 4.3 in the covering letter.
• □ The biosafety and sterile documentation to be submitted have been compiled into separate volumes.
• □ Materials of biological origin have been reassessed under Articles 8.7 and 8.8.
• □ The biological statements have been checked for consistency with 4.2.3 and 4.2.8.

Related reading: Additional Documents for Sterile Devices: Validation, Bioburden, Pyrogens and Sterility (https://www.grzanglobal.com/azerbaijan-medical-device-registration/sterile-device-additional-documents/); Notarised Translation of Instructions for Use: Only for Devices with Medicinal Substances (https://www.grzanglobal.com/azerbaijan-medical-device-registration/notarized-translation-of-instructions-for-use/); Declaration of Conformity with Safety and Effectiveness Requirements and the Risk Degree (https://www.grzanglobal.com/azerbaijan-medical-device-registration/safety-effectiveness-declaration-risk-level/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, biological evaluation strategy, risk classification and exemption reasoning. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.