Medical devices are products with a direct medical purpose but are not classified as medicines. The difference between a medical device and a medicine is that the intended effect of a medical device is not pharmacological, immunological, or metabolic, but rather physical in nature.
To ensure compliance with medical device requirements and the implementation of regulations, the State Agency of Medicines has been designated as the competent authority for the medical device sector as of January 1, 2025, meaning it will be the body responsible for overseeing national compliance.
If you have any questions or concerns regarding a medical device, please contact the Department of Medical Devices at [email protected] and we will work together to find answers to your inquiries.
Last updated: 03.02.2025
