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Authorized Representative in Ukraine

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Confirmation of compliance with the Technical Regulations is carried out on the basis of conformity assessment procedures that are approved

  • Technical regulations for medical devices (Resolution of Cabinet of Ministers of Ukraine No. 753 of 02.10.2013),
  • Technical Regulations for Medical Devices for In Vitro Diagnostics (Resolution of CMU No. 754 of 02.10.2013),
  • Technical regulations for active medical devices that are implanted (Resolution of Cabinet of Ministers of Ukraine No. 755 of 02.10.2013).

Confirmation of compliance is carried out only by a resident of Ukraine. If the manufacturer of products is a non-resident of Ukraine, it is necessary to conclude a contract with a resident of Ukraine on conducting work on conformity confirmation. A resident of Ukraine must have a power of attorney in the established order.

The functions of the authorized representative of the manufacturer in Ukraine are determined by an agreement / power of attorney issued in his name.

Functions of the authorized representative of the manufacturer in Ukraine

Our company renders services of the authorized representative of the manufacturer of medical products in Ukraine.

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