Azerbaijan Medical Device Compliance Calendar 2026–2027: Key Deadlines for the Next 12 Months

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The compliance nodes of Azerbaijan share one common feature: almost all of them are anchored to the certificate issue date or the expiry date, and the periods are generally counted in working days. Consolidating the periods of Rules No. 345 and the Law on Medicines allows a monthly view to be laid out:

Continuous nodes — change capture (Article 1.5, filing within 7 working days of the change), packaging and labelling compliance inspections (Article 11.1.3), vigilance records (Resolution No. 503), batch-by-batch quality files (Article 12.1.4).

Event nodes — deficiency notification 5 working days (7.3), remediation of deficiencies 10 working days (7.4), fee payment 5 working days (6.16), certificate issue 7 working days (7.1), rejection notice 2 working days (5.2), revocation service 2 working days (12.2), import permit 7 working days (9-1.12 plus Article 19.9 of the Licenses and Permits Law), return of exhibition samples 14 calendar days (9-1.8).

Cycle nodes — certificate validity 5 years (8.1), renewal filed at least 7 working days ahead (7.8).

2. Legal basis

Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of 18 July 2024 approving the Rules for the State Registration of Medicines, Pharmaceutical Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (in force from 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Collection 2024, No. 7, Article 906; repealing Resolution No. 108 of 13 July 2007 with effect from 20 July 2024): Article 7.8 (7 working days), Article 8.1 (5 years), Article 7.9 (effect from the following day), Article 7.1 (7 working days), Article 7.3 (5 working days), Article 7.4 (10 working days), Article 6.16 (5 working days), Article 5.2 (2 working days), Article 7.5 (2 working days), Article 12.2 (2 working days), Article 11.3 (immediately), Article 1.5 (changes registered as they occur).
Law of the Republic of Azerbaijan on Medicines (No. 208-IIIQ, adopted 22 December 2006, in force 28 February 2007, Legislative Collection 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, Article 1127): Article 6.11 (5 years), Article 9-1.8 (14 calendar days), Article 9-1.12 (device import permit period).
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: Article 19.9 (7 working days).
Resolution No. 140 of the Cabinet of Ministers of the Republic of Azerbaijan of 25 April 2025 (amending the Rules annexed to Resolution No. 345, harmonising the term registration certificate, qeydiyyat vəsiqəsi, into certificate, vəsiqə; Xalq qəzeti No. 86 of 30 April 2025; Legislative Collection 2025, No. 4, Volume II, Article 426) (terminology amendment, in force in 2025).

3. Expert insights

Insight one: scheduling working days as if they were calendar days is the most common planning error in Azerbaijan. Articles 7.1, 7.3, 7.4, 7.8, 6.16, 5.2 and 12.2 all use working days; only Article 9-1.8 (return of exhibition samples) uses calendar days. Working days must be reduced by the public holidays of Azerbaijan, and projects crossing holidays need extra buffer.

Insight two: the two shortest deadlines are both 2 working days, and both point to adverse outcomes. Article 5.2 (rejection notice) and Article 12.2 (revocation service) are each 2 working days. Their common requirement is that the certificate holder must be able to actually receive correspondence — with a registered letter arriving at an unanswered address, the 2 working days simply pass.

Insight three: 7 working days appears three times, each with a different meaning. Article 7.1 covers certificate issue (from submission of the documents by the applicant; for devices under Article 4.4, from submission of the expertise opinion); the first sentence of Article 7.8 covers the renewal lead time (at least 7 working days before expiry); Article 19.9 of the Licenses and Permits Law covers the import permit review (from registration of the application). The three sevens must not be conflated.

Insight four: 5 working days appears twice, once as an opportunity and once as an obligation. The 5 working days of Article 7.3 are the obligation of the Ministry of Health (the period for notifying deficiencies); the 5 working days of Article 6.16 are the obligation of the applicant (payment of the state fee). Breach of the former can be challenged; breach of the latter stalls the process.

Insight five: the terminology amendment of Resolution No. 140 is already in force, and external documents must follow. Resolution No. 140 of 25 April 2025 replaced the term registration certificate with certificate. The 12-month compliance calendar should schedule one full terminology sweep of external documents, replacing the old wording in a single pass.

4. Practical recommendations

Build a 12-month compliance calendar anchored to the certificate issue date, converting all deadlines into Azerbaijani working days and deducting public holidays.
Create separate calendar entries for the three 7-working-day periods (certificate issue, renewal lead time, import permit); never merge them into one calculation.
Before the two 2-working-day deadlines (rejection notice, revocation service), confirm that the recipient channel of the certificate holder is unobstructed.
Prepare the payment chain in advance for the 5-working-day fee window of Article 6.16.
Set the continuous nodes (change capture, packaging inspections, vigilance records, batch quality files) as quarterly reminders.
Schedule one full terminology sweep of external documents, replacing registration certificate with certificate throughout (Resolution No. 140).

5. Verification checklist

□ A 12-month compliance calendar anchored to the issue date has been built.
□ All working-day deadlines have been reduced by Azerbaijani public holidays.
□ The three 7-working-day periods have separate calendar entries.
□ The recipient channel of the certificate holder has been confirmed unobstructed.
□ The fee payment chain is in place.
□ The external document terminology sweep (registration certificate to certificate) has been completed.

Article 31 — The 5-year validity: Article 6.11 of the Law and Article 8.1 of the Rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/five-year-validity-of-certificate/
Article 33 — The renewal window: 7 working days for devices versus 90 days for medicines: https://www.grzanglobal.com/azerbaijan-medical-device-registration/re-registration-window-7-working-days/
Article 46 — Post-market supervision: current state and gaps: https://www.grzanglobal.com/azerbaijan-medical-device-registration/post-market-supervision-gaps/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and post-market compliance documentation for the Azerbaijan market, from compliance calendars anchored to certificate issue dates to terminology sweeps after Resolution No. 140. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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