Veterinary technical devices (VTDs) are regulated in the Czech Republic and must be registered by the Institute for State Control of the Veterinary Biologicals and Medicines (ÚSKVBL) before being placed on the market.
VTDs are regulated and defined in Act No. 166/1999 Coll. on Veterinary Care, as amended, and Regulation No. 159/2021 Coll., on Veterinary Products and Veterinary Technical Devices. The requirements for VTDs are subject to further regulations that must be considered during the registration process - for example, legislation on the protection of animals against cruelty.
The category of VTDs includes equipment, materials, surgical instruments and aids or devices (in combination with software), intended for use in animals for the following purposes: prevention, diagnosis, monitoring of treatment, monitoring of health status or devices for marking animals (e.g. microchips). Furthermore, this category includes equipment intended to replace or modify anatomical structures or physiological processes that do not achieve their primary intended action by pharmacological, immunological, or metabolic means.
The application form for the entry of a veterinary technical device into the Register of VTDs must be submitted together with the additional documentation specified in the application form, including proof of payment of the administrative fee.
The decision issued to the licence holder is valid for 5 years and may be renewed upon submission of a renewal application. This must be submitted no later than 30 days before the decision expires; otherwise, the product will be removed from the Register of Veterinary Technical Devices.
Throughout the validity period of the VTD registration decision, the holder must notify the ÚSKVBL of any amendments to the documentation submitted within the initial application and request their approval by submitting an application for a variation. Examples of variations include changes to the VTD’s composition, intended use, target animal species, method of use, storage conditions, packaging, manufacturing site, or safety-related information (SDS).