Free Mongolia medical device classification tool

What the Mongolia classifier checks

How are medical devices classified in Mongolia?

Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency), abbreviated ЭЭХХЗГ uses a risk-based framework. Possible classes include IVDs: Class A (бага эрсдэлтэй), Class B (дунд эрсдэлтэй), Class C (дунд эрсдэлтэй), Class D (өндөр эрсдэлтэй); Medical devices: Grade I (бага эрсдэлтэй), Grade IIa (дунд эрсдэлтэй), Grade IIb (дунд эрсдэлтэй), Grade III (өндөр эрсдэлтэй). Order A/136 §2.4 of the head of the Medicines and Medical Devices Control and Regulatory Agency writes the four IVD classes as three risk grades, verbatim: 'Лабораторийн оношилгооны хэрэгслийг эрсдэлийн зэргээр бага (A), дунд (B, C), өндөр (D) эрсдэлтэй гэж ангилна' — low (A), medium (B and C), high (D). The grade word is the Order's own risk descriptor and the class letter subdivides it, so the two medium classes carry the identical descriptor: the classification rules repeat one grade word over both, most directly at §§5.4.1 and 5.4.2, adjacent rules in the same subsection that send self-testing devices to 'дунд эрсдэлтэй буюу B зэрэгт хамаарна' and 'дунд эрсдэлтэй буюу C зэрэгт хамаарна' (and §5.3.7 likewise to 'дунд эрсдэлтэй буюу C зэрэгт хамаарна'). B and C are therefore distinguished only by which rule applies, and the Order gives neither a risk word of its own. §2.6 resolves a device falling within two or more grades by entering it in the list of the highest grade. Classification is applied through the classification list built on the GMDN nomenclature (§3.1), and the classification procedure and list are approved by the Agency head under Art. 33.3 of the Law on Medicines and Medical Devices. Order A/136 §2.2 classifies medical consumables and medical equipment by risk grade, verbatim: 'Эмнэлгийн хэрэглэгдэхүүн, эмнэлгийн тоног төхөөрөмжийг эрсдэлийн зэргээр бага (I), дунд (IIa, IIb), өндөр (III) эрсдэлтэй гэж ангилна' — low (I), medium (IIa and IIb), high (III). The grade word is the Order's own risk descriptor and the class subdivides it, so the two medium classes carry the identical descriptor: the rules send a device to 'дунд эрсдэлтэй буюу IIa зэрэгт хамаарна' (§4.7.1, short-term surgically invasive devices) or to 'дунд эрсдэлтэй буюу IIb зэрэгт хамаарна' (§4.6.6, absorbed devices), and IIa and IIb are distinguished only by which rule section applies — the Order gives neither a risk word of its own. §2.6 resolves a device falling within two or more grades by entering it in the list of the highest grade. §3.6 permits the risk grade the device falls under in its country of manufacture to be taken into account, verbatim 'үйлдвэрлэсэн улсдаа ямар эрсдэлийн зэрэгт хамаарч байгааг харгалзан үзэж болно', which is a classification input on the same three-grade axis and creates no approval-recognition route. The classification list is built on the GMDN nomenclature (§3.1) and is approved by the Agency head under Art. 33.3 of the Law on Medicines and Medical Devices. 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 Mongolia classifier use?

Current official Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency), abbreviated ЭЭХХЗГ classification requirements. Your result includes an explanation and links to the official sources used.

Is the result an official Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency), abbreviated ЭЭХХЗГ 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.