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Authorised Representative Ukraine

Before start registration procedure it is necessary to assign the authorised representative (AR). It must be the resident of Ukraine, legal entity. It might be separate firm or distributor. However it is recommended to split the commercial and regulatory activity, as the later is the direct responsibility of the manufacture and defined by quality policy which has not being affected by influence of commercial.

Our company offers the Authorised Representative service and provides the following functions:  

-acts and serves as addresser for conformity assessment bodies instead of manufacture with regard to current obligations in compliance with valid Technical regulations

-notifies the competent bodies about the changes of manufacture

-notifies the competent bodies about medical devices of the manufacture

-notifies the competent bodies about the changes in medical devices

-serves as contact for specialized inspections in the matter of MD safety

-prepares technical documentation on request

-gets the information about the accidents, adverse effects from the competent bodies

-serves as contact between conformity assessment body and manufacture

-in case of wrong application of conformity assessment symbol do the amendments into marking

-for MD intended for clinical evaluation follows to the determined procedure and informs competent authorities.

   Our service of Authorised Representative is not simple operation as mail box: we serves as guide in regulatory sphere; helps in solving of regulatory notes directed to your company; communicates with competent authorities. All these require definite knowledge in regulatory sphere, technical and science background and ability to interact with correspondent bodies.