In those countries where it is compulsorily required for the Medical Devices registration with the relevant competent Authority, the Registration Holder owns the registration and its references must be therefore included in the product label. For this reason it’s important to conveniently select the Holder for devices registration and the winning track is definitely not being bound to a distributor. Once you obtained the registration, you may transfer the registration ownership only upon “outgoing” Registration Holder approval. Sometimes, according to the country specific Regulation, it’s necessary to submit a written agreement between the previous Registration Holder and his substitute to the competent Authority.
