The Authorized Representative requirement explained
Published:
Foreign manufacturers must appoint a locally established Authorized Representative recorded on the State Register.
A manufacturer that is not established in Uzbekistan cannot hold a registration certificate directly. Resolution No. 738 requires a locally established Authorized Representative, whose details are recorded on the State Register alongside the device.
The appointment is made by a Power of Attorney from the manufacturer. The Authorized Representative is the point of contact for the Center for Pharmaceutical Products Safety, holds the technical file, signs the electronic submission with an e-imzo signature, and carries post-market obligations including vigilance reporting and field safety corrective actions.
Because the certificate is tied to the representative, changing representative mid-life requires a variation to the registration. Plan the appointment before the dossier is compiled, not after.