Free Armenia medical device classification tool

What the Armenia classifier checks

How are medical devices classified in Armenia?

Ministry of Health of the Republic of Armenia uses a risk-based framework. Possible classes include IVDs: Class 1 — low individual risk and low public-health risk, Class 2a — medium individual risk and low public-health risk, Class 2b — high individual risk and/or medium public-health risk, Class 3 — high individual risk and high public-health risk; Medical devices: Class 1 — low risk, Class 2a — medium risk, Class 2b — increased risk, Class 3 — high risk. In vitro diagnostic medical devices are classified on their own axis under EEC Board Decision No. 173 of 22 December 2015 section III, again in four classes 1, 2a, 2b and 3, but the classifier is the combination of individual risk and public-health risk rather than the invasiveness ladder used for other devices. Armenian law names in vitro diagnostic means separately in both the registration chapter and the state-duty schedule, so they are published as their own scheme. Armenia applies the class axis of the Eurasian Economic Union directly: EEC Board Decision No. 173 of 22 December 2015 section II paragraph 4 sets four classes — class 1 (low risk), class 2a (medium risk), class 2b (increased risk) and class 3 (high risk) — with one class per device. Armenian law does not restate the criteria; Article 46(9) of the Law on Medical Care and Services to the Population imposes the duty to divide devices into classes by the degree of potential risk and attaches consequences to the class, and Article 45(2) gives the concepts of the medical-device chapter the meanings fixed by EAEU acts. 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 Armenia classifier use?

Current official Ministry of Health of the Republic of Armenia 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 Armenia 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.