Azerbaijan Medical Device Vigilance: The Current Legal Basis Borrowed from Drug Rules

1. Key takeaways

Azerbaijan has no standalone vigilance rules for medical devices. What can currently be invoked is Resolution No. 503 of the Cabinet of Ministers of 25 December 2019 on Pharmacovigilance Rules, which Rules No. 345 references directly at two points:

Article 11.1.2 — where a benefit/risk assessment conducted under Resolution No. 503 concludes that the product lacks or has insufficient therapeutic effectiveness, the State registration is suspended;

Articles 12.1.1 and 12.1.2 — where the certificate holder breaches vigilance obligations set by Resolution No. 503, or the benefit/risk assessment concludes with a negative result, the State registration is revoked.

In addition, Article 11.1.1 lists as a suspension ground adverse effects not stated in the instructions for use that occur even when the product is used as intended and correctly in accordance with those instructions — the provision closest to a device adverse-event rule in the current framework.

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 11.1.1 (adverse effects not stated in the instructions for use), Article 11.1.2 (benefit/risk assessment under Resolution No. 503), Article 12.1.1 (breach of vigilance obligations), Article 12.1.2 (negative benefit/risk assessment), Article 12.1.4 (inconsistencies in the quality indicators of three batches), Articles 10.6 and 10.7 (Register entries and publication).
• Resolution No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan of 25 December 2019 on Pharmacovigilance Rules (the substantive basis of the current vigilance obligations).
• Resolution No. 460 of the Cabinet of Ministers of the Republic of Azerbaijan of 27 November 2019 on the Rules for the Withdrawal of Medicines (the basis of recalls).
• 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 1-1 (list of provisions applicable to devices), Article 16 (media publication).

3. Expert insights

Insight one: device vigilance borrows the drug rules rather than being excluded. Article 1-1 of the Law on Medicines lists many drug provisions as inapplicable to devices, but Resolution No. 503 on Pharmacovigilance Rules is a Cabinet of Ministers resolution, not a provision of the Law on Medicines, and is therefore outside the exclusion list of Article 1-1. Articles 11.1.2, 12.1.1 and 12.1.2 of Rules No. 345 then write it directly into the suspension and revocation grounds. The conclusion: device certificate holders in fact carry vigilance obligations benchmarked against drug rules.

Insight two: Article 12.1.1 sets breach of vigilance obligations directly as a revocation ground — a very strong constraint. The Rules do not detail what device certificate holders must specifically do, but the consequence of breach is revocation of State registration. Practical estimate: in the absence of device-specific rules, it is advisable to build a record system for adverse event collection, assessment, reporting and benefit/risk assessment by reference to Resolution No. 503, and to retain the records as evidence of performance.

Insight three: Article 11.1.1 is the closest landing point for device adverse events. The provision covers adverse effects not stated in the instructions for use that occur when the product is used as intended and correctly in accordance with those instructions. This effectively requires the list of adverse effects in the instructions for use to be as complete as possible (for drug-containing devices, the instructions are checked by the AEC and confirmed by the Ministry of Health under Article 9.1); otherwise any unstated adverse effect can trigger suspension.

Insight four: recalls run on the drug rules. Article 11.2 provides that after suspension the Ministry of Health decides under Resolution No. 460 on the Rules for the Withdrawal of Medicines whether to recall products in circulation. Device recalls have no standalone procedure, which means the criteria and the process for a device recall must be borrowed from the drug rules.

Insight five: vigilance data can flow into the public record in both directions. Article 10.6 requires the Register to record suspensions and revocations, and Articles 11.4 and 12.3 require publication in the media or the periodical press. The consequences of a vigilance event therefore go beyond internal remediation and enter the public record.

4. Practical recommendations

1. In the current absence of device-specific rules, build a record system for adverse event collection, assessment, reporting and benefit/risk assessment by reference to Resolution No. 503.
2. Retain and periodically archive all vigilance records as evidence of performance against the revocation ground of Article 12.1.1.
3. Make the list of adverse effects in the instructions for use as complete as possible; for drug-containing devices, follow the AEC check and Ministry of Health confirmation of Article 9.1.
4. Draft the recall plan under Resolution No. 460 on the Rules for the Withdrawal of Medicines rather than inventing a device-specific process.
5. Monitor the AEC website for dedicated device vigilance rules or notices and include this in the quarterly review.
6. After handling a vigilance event, assess in parallel whether change of State registration under Article 1.5 is triggered, for example where the instructions for use need additional adverse effects.

5. Verification checklist

• □ Adverse event collection, assessment and reporting procedures have been built by reference to Resolution No. 503.
• □ A periodic benefit/risk assessment mechanism with records is in place.
• □ Vigilance records are archived and usable as evidence of obligation performance.
• □ The completeness of the adverse-effect list in the instructions for use has been reviewed.
• □ The recall plan has been drafted under Resolution No. 460.
• □ Dedicated AEC device vigilance rules are on the quarterly review list.

• Article 43 — Cancellation of State registration: 5 grounds and 2-working-day service: https://www.grzanglobal.com/azerbaijan-medical-device-registration/cancellation-of-state-registration/
• Article 45 — Post-market file consistency maintenance and the annual self-check: https://www.grzanglobal.com/azerbaijan-medical-device-registration/post-market-file-consistency-maintenance/
• Article 41 — The State Register: the seven data fields for devices: https://www.grzanglobal.com/azerbaijan-medical-device-registration/state-register-seven-data-fields/

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 adverse event record systems benchmarked to Resolution No. 503 to recall plans under Resolution No. 460. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.