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. The Analytical Expertise Center's expertise time sits largely outside that clock (§7.12), which is why the planning range is in months while the published clock is in days. Where deficiencies are notified, §7.3 gives the Ministry five working days from registration of the application to raise them and §7.4 gives the applicant a cure period; a certificate for a change to a registered device is issued within seven working days of the expertise opinion reaching the Ministry (§7.2, §6.12). | 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. The registration certificate is valid for five years (§8.1), and every change to the information in the registration documents must be registered, the holder applying within seven working days (§7.8). The dossier for a device containing a medicinal substance as a component must additionally have that substance examined before registration (§4.4). | 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. Every consignment must additionally be supported at import by the documents Article 9-1.9 of the Law on Medicinal Products requires, including the certificate of origin and the manufacturer's batch quality document. | 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.