Authorized representative of the manufacturer of medical devices in Ukraine.

Postmarketing surveillance system is an essential element in the overall quality management system of the manufacturer of medical devices.

This system is designed, documented and implemented by the manufacturer in order to improve product safety criteria.

Postmarketing surveillance of medical devices in foreign countries (outside the manufacturing country), in particular – in Ukraine, is carried out by the Authorized representatives of the manufacturer.

According to the Law of Ukraine “On technical regulations and conformity assessment”,

Authorized Representative – any individual or legal entity – resident of Ukraine which received from the manufacturer a written authorization to act on its behalf in relation to tasks specified in this authorization.

The manufacturer can delegate functions of the Authorized representative both to importer/distributor of products and an independent contractor whose profile of activities ensures competent performance of such tasks.

Range of duties and level of responsibility of the Authorized representative are determined by an agreement between the parties and the Authorized representative is appointed before the initiation of the conformity assessment procedure. Standard functions of the Authorized representative are specified in the Technical regulations.

The authorized representative is entitled to represent interests of the manufacturer in the conformity assessment bodies, to apply for activities on conformity assessment of products with technical regulations, to submit and obtain the necessary documents, as well as to address other issues in the course of conformity assessment activities.

Labeling of products for the Ukrainian market includes the details of the Authorized representative which is an intermediary between the manufacturer and the regulatory/supervisory authorities in Ukraine, as well as directly between the manufacturer and consumers.

For high-quality performance of functions the Authorized representative needs the relevant knowledge and experience, which we are happy to share in the course of cooperation.

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