Azerbaijan Registration Dossier: The 11 Items of Article 4.2 Broken Down One by One

1. Key takeaways

Article 4.2 of Registration Rules No. 345 requires that, in order to obtain state registration (re-registration) of higher, high and medium risk devices, the applicant must submit, together with the application form in Annex 1, a dossier of 11 items to the Ministry of Health. The items run from 4.2.1 to 4.2.11 and form the complete documentary backbone of the application.

4.2.1 a copy of the document confirming the right of the manufacturer to manufacture, together with its annexes; 4.2.2 a document confirming foreign registration (in the manufacturing country; if not registered there, in another country) or a free sale or export certificate, where available, with a notarised translation into Azerbaijani; 4.2.3 a brief description by the manufacturer of the intended scope, purpose and composition of accessories; 4.2.4 label and packaging information from the manufacturer (colour specimens of packaging and labels with Azerbaijani-language content).

4.2.5 where a medicinal substance is incorporated, information on its composition, quantity and compatibility with the device; 4.2.6 biosafety information provided by the manufacturer; 4.2.7 for sterile devices, test methods and packaging validation, microbiological (bioburden level), pyrogenicity and sterility test results and process validation information (notarised Azerbaijani translation); 4.2.8 a declaration of conformity with safety and effectiveness requirements issued by the manufacturer, which must indicate the risk degree; 4.2.9 a copy of the manufacturer’s quality management system certificate; 4.2.10 the documents listed in Articles 18.2.1 to 18.2.3 of the Law on Licenses and Permits; 4.2.11 a copy of the usability documentation for second-hand devices.

Article 4.3 adds three exemptions: items 4.2.1, 4.2.2, 4.2.8 and 4.2.9 do not apply to devices manufactured in Azerbaijan; item 4.2.5 does not apply to devices that obtain information by examining human samples in a test tube (IVDs); item 4.2.6 does not apply to devices that do not contact the human body.

2. Legal basis

• 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): Articles 4.2.1 to 4.2.11 (the 11 dossier items), Article 4.3 (three exemptions), Article 4.5 (documents obtainable under Article 3.6), Article 4.1 (three-stage process), Article 2.1.1 (definition of applicant), Article 2.1.4 (definition of accessories).
• Law of the Republic of Azerbaijan on Licenses and Permits (No. 176-VQ of 15 March 2016), Articles 18.2.1–18.2.3, 19.9, 25 and 26.1 — specifically the documents under Articles 18.2.1 to 18.2.3.
• 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 2.1.10 (definition of accessories), Article 3.8 (accessories classified separately).

3. Expert insights

Insight one: the 11 items contain no instruction-for-use and no clinical trial report. Compared with dossiers in the European Union, the United States or the Chinese mainland, the Azerbaijani device dossier is visibly leaner: its core consists of three self-declaratory manufacturer documents (4.2.3 brief description, 4.2.5 medicinal substance information, 4.2.6 biosafety, 4.2.8 conformity declaration) plus three third-party proofs (4.2.1 manufacturing right, 4.2.2 foreign registration or FSC, 4.2.9 QMS certificate). This is a facilitation, but it also means the responsibility for the conformity declaration and the risk-degree annotation rests entirely on the manufacturer.

Insight two: Article 4.2.2 is structured as a priority-based election with a fallback. The registration certificate of the manufacturing country comes first; if the manufacturing country does not perform state registration, a certificate from another country is used; free sale or export certificates apply only where available. For manufacturers from the Chinese mainland with a domestic registration certificate, that certificate should be used first; for product categories exempt from domestic registration, a free sale or export certificate should be prepared. Either route requires a notarised Azerbaijani translation.

Insight three: the exemptions of Article 4.3 turn on product attributes, not on applicant identity. Local production is exempt from four items — 4.2.1, 4.2.2, 4.2.8 and 4.2.9 — logically, because domestic manufacturing needs neither a foreign manufacturing right nor foreign market authorisation, and repeating self-declarations adds nothing. IVDs are exempt from 4.2.5 because the testing principle of a reagent is not administration of a substance to the body. But items 4.2.10 and 4.2.11 have no exemption at all: entity documents and second-hand usability documentation are required for every device.

Insight four: Article 4.2.8 requires the risk degree to be indicated, embedding the classification conclusion in the manufacturer’s declaration. This forms a triangle with Article 10.4.3 (risk degree in the register) and Annex 5 (risk degree on the certificate). If the degree written in the manufacturer’s own declaration conflicts with the determination of the Ministry of Health under Decision No. 8, the case falls into Article 5.1.4 — inconsistencies related to quality, effectiveness or safety found in the submitted documents.

4. Practical recommendations

1. Build a status-columned checklist from 4.2.1 to 4.2.11, marking each item applicable, exempt or outstanding, with the supporting article cited.
2. Under 4.2.2 prefer the manufacturing-country certificate, then another-country certificate, then the FSC; whatever is chosen, obtain the notarised Azerbaijani translation.
3. Ensure the risk degree in the 4.2.8 conformity declaration matches the Decision No. 8 determination verbatim.
4. For locally manufactured products, IVDs and non-body-contacting devices, verify each Article 4.3 exemption item by item and cite the articles in the cover letter.
5. Submit the manufacturing-right proof of 4.2.1 together with its annexes, never the main certificate alone.
6. Prepare the three 4.2.10 entity documents early; they expire quickly and renew slowly, and are the most common reason for returned applications.

5. Verification checklist

• □ A status-columned dossier checklist from 4.2.1 to 4.2.11 is in place.
• □ The 4.2.2 route (manufacturing-country certificate / other-country certificate / FSC) has been selected and notarised translations completed.
• □ The 4.2.3 brief description (scope, purpose, accessories) is finalised.
• □ Azerbaijani-language colour specimens of labels and packaging under 4.2.4 are ready.
• □ The risk degree in the 4.2.8 conformity declaration matches the classification determination.
• □ Article 4.3 exemptions have been confirmed item by item and cited in the cover letter.
• □ The three 4.2.10 entity documents are complete.

• Article 14 — Foreign registration certificate and free sale certificate: how to combine the two routes: https://www.grzanglobal.com/azerbaijan-medical-device-registration/foreign-registration-or-free-sale-certificate/
• Article 15 — Additional documents for sterile devices: validation, bioburden, pyrogenicity and sterility: https://www.grzanglobal.com/azerbaijan-medical-device-registration/sterile-device-additional-documents/
• Article 21 — The application form (Annex 1): completion points and the criminal liability statement: https://www.grzanglobal.com/azerbaijan-medical-device-registration/application-form-annex-1/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in assembling the 11-item registration dossier for medical devices in Azerbaijan, from Article 4.3 exemption analysis and notarised translation management to conformity declarations aligned with the Decision No. 8 risk degree. For tailored assistance with your Azerbaijan dossier, contact us at info@grzanglobal.com.