Medical device manufacturers located outside the Ukrainian are required to have a Authorized Representative in accordance with the:
Technical Regulation on medical devices, approved by Decree of Cabinet of Ministers of Ukraine № 753 as of 2 October 2013
Technical Regulation on medical devices for in vitro diagnostics, approved by Decree of Cabinet of Ministers of Ukraine №754 as of 2 October 2013
Technical Regulation on active implantable medical products, approved by Decree of Cabinet of Ministers of Ukraine №755 as of 2 October 2013
All non-Ukrainian manufacturers are required to identify a ‘person’ or ‘entity’ established in the Ukrainian who is authorized to keep the manufacturers technical file or have quick access to it. The Authorized Representative must have a written mandate (agreement) from the manufacturer before its name appears on the Declaration of Conformity along with the name and address of the manufacturer.
The term ‘Authorized Representative’ does not describe a sales and marketing function, it describes a compliance/regulatory affairs function only.
Release of a credible technical file should not be taken lightly since it contains confidential and proprietary/design information. It is therefore of great importance to appoint an established and knowledgeable UA Authorized Representative firm in accordance with an UA legal agreement that includes confidentiality.
To obtain an Authorized Representative proposal please complete the application online by clicking HERE.
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