Free Azerbaijan medical device classification tool

What the Azerbaijan classifier checks

How are medical devices classified in Azerbaijan?

Ministry of Health of the Republic of Azerbaijan uses a risk-based framework. Possible classes include Sinif 1 — low risk degree (aşağı), Sinif 2a — medium risk degree (orta), Sinif 2b — high risk degree (yüksək), Sinif 3 — higher risk degree (daha yüksək). Azerbaijan classifies medical devices by the degree of potential risk associated with their application into four degrees: sinif 1 (low), sinif 2a (medium), sinif 2b (high) and sinif 3 (higher). The scale is set by Ministry of Health Collegium Decision No. 8 of 21 May 2024, §3.3, with the criteria in §3.1 and the allocation rules in Sections 4-6 and 8; Section 7 of the same classification allocates in vitro diagnostic devices to the same four degrees. Only the three higher degrees are state-registered: §3.4 of Decision No. 8 and §1.2.3/§4.2 of Cabinet Resolution No. 345 confine registration to devices whose risk degree is higher, high or medium, so a class 1 device sits outside the registration regime. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Azerbaijan classifier use?

Current official Ministry of Health of the Republic of Azerbaijan classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Ministry of Health of the Republic of Azerbaijan classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.