Azerbaijan Medical Device State Registration: The Full Application, Expertise and Issuance Process

1. Key takeaways

State registration of medical devices in Azerbaijan follows a three-stage chain: application (the dossier is submitted to the Ministry of Health under Part 4 of the Rules), expert examination (performed by the Analytical Expertise Center, AEC, under Resolution No. 502), and certification (the Ministry of Health issues the certificate under Part 7). Article 4.1 folds these three stages into a single definition, which means no applicant can skip or reorder any of them.

Three numbers govern the timeline: certificate issuance within 7 working days (Article 7.1), deficiency notice within 5 working days (Article 7.3), and deficiency remedy within 10 working days (Article 7.4, under which the issuance clock is suspended during the remedy period and that suspension does not count toward the issuance deadline). In addition, Article 6.16 requires the applicant to pay the state fee within 5 working days after receiving notice from the institution, under the Law on State Fees.

The practical message is that the headline 7-working-day figure covers only the final issuance leg. Dossier preparation, the AEC examination and any deficiency cycle sit outside it, so realistic planning must model all three stages plus the fee window as separate, differently-owned segments.

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): Article 4.1 (application–examination–issuance chain), Article 4.2 (the 11 dossier items), Article 4.5 (documents obtainable under Article 3.6), Article 3.6 (documents obtainable by the institution through the e-government information system are not required from the applicant), Article 6.16 (state fee payable within 5 working days after notice from the institution), Article 7.1 (issuance within 7 working days), Article 7.3 (deficiency notice within 5 working days), Article 7.4 (remedy within 10 working days, suspension of the deadline), Article 7.12 (the examination period is excluded from the issuance review period).
• Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated 25 December 2019 on the Rules for Performing Expertise of Medicines (including simplified expertise) (Xalq qəzeti No. 290 of 28 December 2019; Legislative Bulletin 2019 No. 12, item 2083; effective 1 July 2020) — the expertise implementation rules.
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated 18 July 2024 (same instrument as above): Article 1.6 (import, domestic production, sale and use are permitted only after registration), Article 8.1 (certificate valid for 5 years).

3. Expert insights

Insight one: two of the three stages are outside the applicant’s control. The application stage is the only one an applicant can compress, by making the dossier complete. The examination is performed by AEC under Resolution No. 502, and the issuance is executed by the Ministry of Health under Part 7. Article 7.12 goes further: for devices containing a medicinal substance under Article 4.4, the legally required examination period is excluded from the review period for the issuance application. You cannot simply add the three stages together when building a schedule.

Insight two: Articles 3.6 and 4.5 create a burden-reduction channel, but it is discretionary. Under these provisions, where documents or information required with the application under Articles 4.2 and 4.3 can be obtained by the institution itself under Article 3.6 through the e-government information system from the relevant state bodies, that route applies. Article 3.6 also states that what can be obtained is not requested from the applicant; what cannot be obtained may be requested from competent authorities with the applicant’s consent, or provided by the applicant. Do not count on automatic relief in practice — prepare against the full list first.

Insight three: fee payment is a standalone node with its own deadline. Article 6.16 places payment within 5 working days after receipt of notice from the institution, grounded in Articles 1-1 and 6.10 of the Law on Medicines. This is an easy gate to get stuck at: the AEC notice first reaches the local entity of the certificate holder, is then forwarded to the foreign manufacturer, and then a cross-border payment must be executed — 5 working days is very tight.

Insight four: Article 6.12 (the medicinal products clause) does not apply to devices, but Article 7.2 gives devices an analogous continuity mechanism. When a registered device is modified, the validity of the new certificate is limited by the validity of the previous certificate (final sentence of Article 7.2). Combined with the day-after-effective renewal rule of Article 7.9, this forms an arrangement designed to avoid import interruption. Plan initial issuance, modification and renewal on a single Gantt chart.

4. Practical recommendations

1. Build a three-column Gantt schedule: application (self-managed), examination (AEC), issuance (Ministry of Health), with the 5-working-day fee window marked separately.
2. Start the payment workflow the moment the AEC notice reaches the local entity of the certificate holder; do not wait for head-office approval abroad before starting.
3. Prepare documents against the complete Article 4.2 list; do not presuppose Article 3.6 relief, and if the institution grants it, obtain written confirmation.
4. Flag devices containing a medicinal substance as examination-excluded-from-issuance and state this explicitly in client schedule discussions.
5. Reserve one full remedy cycle of 5 plus 10 working days as buffer; never schedule on a zero-deficiency assumption.
6. Record every milestone in a written log: submission date, application registration date, fee payment date, deficiency notice date, remedy submission date, certificate issuance date.

5. Verification checklist

• □ The three-stage process (application / examination / issuance) has been confirmed under Article 4.1 and mapped on a Gantt chart.
• □ Documents are prepared against the complete Article 4.2 list, without presupposed relief.
• □ A payment channel is in place to complete the fee within 5 working days after the AEC notice.
• □ Whether the product falls under Article 4.4 (medicinal substance) has been confirmed and the examination period flagged.
• □ The schedule reserves a 5 plus 10 working-day remedy buffer.
• □ A six-milestone written log (submission / registration / payment / deficiency / remedy / issuance) is maintained.

• 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 18 — Certificate issued in 7 working days: there are actually two start points: https://www.grzanglobal.com/azerbaijan-medical-device-registration/certificate-issued-in-7-working-days/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing state registration applications for medical devices in Azerbaijan, from Article 4.2 dossier assembly and AEC examination planning to fee logistics and milestone tracking. For tailored assistance with your Azerbaijan medical device registration, contact us at info@grzanglobal.com.