Regardless of the risk class, all Medical Devices must be registered to be marketed in Russia. The registration process is fairly detailed and consists of administrative phases to open the registration practice with the competent Authority, technical phases culminating in the submission of a product technical dossier to the competent Authority, and finally, phases of technical and clinical tests that must be carried out on a sufficient number of product samples in Russian laboratories. Therefore, timeframes for Medical Devices registration in Russia vary from 12 to 16 months.