Medical devices for animals
Published:
Changes
In Norway, veterinary medical devices do not have a dedicated regulatory framework. Such products, defined as veterinary medical devices elsewhere, are classified in Norway as pharmaceuticals or commercial items.
In Norway, there is no separate regulation for medical devices for animals. Products for in vivo diagnostics, products containing pharmaceutical substances, and products for injection will typically be classified as pharmaceuticals in Norway. Pharmaceuticals cannot be marketed without approval from the Norwegian Medical Products Agency.
Technical equipment and in vitro diagnostic devices are usually considered commercial devices that do not require regulatory approval before marketing. However, all electrical devices must comply with relevant electrical equipment regulations and be CE-marked according to the Low Voltage Directive, regardless of the intended use.
Also, please be aware that anyone conducting sales in Norway must adhere to the Product Liability Act.