Free Kuwait medical device classification tool

What the Kuwait classifier checks

How are medical devices classified in Kuwait?

Ministry of Health uses a risk-based framework. Possible classes include Class A — Low risk, Class B — Low-moderate Risk, Class C — Moderate-high Risk, Class D — High Risk. Kuwait uses a single four-class risk axis for medical devices and for in-vitro diagnostic devices alike. Section 8.1(a) of the annex to Ministerial Decree No. (387) of 2025 states that the classification system consists of four classes 'where Class A represents the lowest hazard and Class D the highest', and the section 8.2 class table heads itself 'Proposed general classification system for Medical Devices & IVD Devices' and gives Class A as Low risk, Class B as Low-moderate Risk, Class C as Moderate-high Risk and Class D as High Risk. Classification turns on the manufacturer's intended use and the technology used, the manufacturer must document its justification for the class it chooses, and where two or more rules apply the device is allocated the highest level of classification indicated. 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 Kuwait classifier use?

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

Is the result an official Ministry of Health 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.