Azerbaijan medical device registration timeline
Source-linked clocksMinistry of Health of the Republic of Azerbaijan (Ministry of Health) review clocks and end-to-end planning ranges, using the Four risk degrees set by Ministry of Health Collegium Decision No. 8 of 21 May 2024 §3.3 — sinif 1 (low), sinif 2a (medium), sinif 2b (high) and sinif 3 (the highest), with in vitro diagnostic devices expressly outside the scale; only the increased, high and medium degrees are state-registered, per Cabinet Resolution No. 345 §1.2.3 classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Sinif 2a (medium risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry) The seven-working-day clock of §7.1 is the Ministry's own decision time and applies where the submitted documents are free of deficiencies; it starts from submission of the application, or from the date the deficiency is cured where one was notified. | 7 working days | 6-12 months | — | Verified |
| Sinif 2b (high risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry) Same seven-working-day Ministry clock as the other registerable degrees (§7.1); the degree changes the depth of the expertise file, not the published decision period. | 7 working days | 8-15 months | — | Verified |
| Sinif 3 (highest risk) — state registration(National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry) Same seven-working-day Ministry clock (§7.1); the realistic range reflects the fuller clinical and technical file the highest degree carries through the expertise stage. | 7 working days | 10-18 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Azerbaijan Medical Device Registration Process
Step-by-step Ministry of Health registration process. Total estimated timeline: 6-12 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Applicant (ərizəçi) established in Azerbaijan — the manufacturer, a wholesale pharmaceutical enterprise, the inventor or the Ministry of Health itself, filing with the Ministry through the Annex No. 1 application form; there is no separate authorised-representative institution and no evidence that a foreign manufacturer may file directly.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMinistry of Health reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
7 working daysIn-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Ministry of Health issues Azerbaijan market authorization certificate.
- Determine the device's risk degree against the four-degree scale of Ministry of Health Collegium Decision No. 8 of 21 May 2024 §3.3 and check the device against the risk list approved by Collegium Decision No. 7 of 21 May 2024; a device of medium, high or increased degree must be state-registered before it is imported, manufactured, sold or used (Cabinet Resolution No. 345, §1.2.3, §1.6).
- File the registration application with the Ministry of Health in the Annex No. 1 form and pay the state duty within five working days of the Analytical Expertise Center's notification (§6.16).
- Carry the registration through expertise by the Analytical Expertise Center and obtain the registration certificate (qeydiyyat vəsiqəsi) from the Ministry of Health, valid for five years (§8.1).
- Register every change to the information in the registration documents, applying to the Ministry within seven working days (§7.8).
- For an import consignment, present the documents Article 9-1.9 of the Law on Medicinal Products requires, including a copy of the certificate of origin, proof of rights over the storage and import premises, a notarially certified copy of the sale-purchase contract, invoices identifying each device by full name, serial number and expiry or service life, and the manufacturer's quality-results document for each batch; used devices additionally need a manufacturer or seller document on serviceability (Article 9-1.10).
- Where the device measures and is used in healthcare, obtain type approval for the measuring instrument and have it verified before being put into service and periodically thereafter (Law 686-IVQ, §11.1, §11.3, §12.1).
- Where the device contains a radio module, obtain the radio-frequency allocation from the State Commission on Radio Frequencies under Cabinet Decision No. 22 of 1 February 2007 §2.1, supporting the application with the manufacturer's certificate and the State Radio Frequencies Administration's opinion on the planned frequencies and electromagnetic compatibility (§2.12); equipment without a conformity certificate may not be used on a radio network (§2.34).
- Where the device is or contains an ionizing-radiation source, hold the Annex No. 3 permit under the Law on Licences and Permits 176-VQ for its operation, and obtain the State Agency for Regulation of Nuclear and Radiological Activity's opinion for its import.
Reviewed 2026-09-16. End-to-end totals remain planning estimates.