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Authorized representative manufacturer of medical devices

One of the first steps on the way to Ukrainian market is an organization’s choice, which will be able to perform the duly authorized representative’s duties, based on the requirements of Ukrainian legislative instruments and statutory instruments.

In the event that the medical products’ manufacturer is a non-resident company of Ukraine, the manufacturer is obliged to appoint the proper duly authorized representative – a resident company of Ukraine (hereafter – DAR). Similar obligation is prescribed subject to compliance with the Technical guideline’s requirement in respect of the medical products, affirmed by the decree of Ukraine’s Cabinet of Ministers dated 02.10.2015 № 753 (hereafter – TG).

The duly authorized representative – could be otherwise stated as an “interlink” between the  manufacturer and the governing institutions, with which the corresponding functions of market surveillance are entrusted. These functions include oversight of the medical products’ circulation within the territory of Ukraine.

According to the definition of “the Duly authorized representative”, reported in clause 2 of the TG, the duly authorized representative gets entrusted with responsibility of entering into legal acts on the manufacturer’s behalf. These acts are related to his (the manufacturer’s) obligations, established by the corresponding Technical guidelines.

By analogy with the EU, some legislative instruments of Ukraine, related to the conformity assessment procedure also contain reference to the fact that the DAR is obliged to keep technical records. These technical records concern the medical products, in respect of which the DAR was appointed. For example, clause 6 of article 8 of the Law of Ukraine “On state market surveillance and oversight of non-food products” (http://zakon2.rada.gov.ua/laws/show/2735-17/print1443093829474422).

The legislative instruments of Ukraine do not determine the stage of the conformity assessment procedure, which requires the appointment of the duly authorized representative. However, in view of practical aspects of the medical products’ conformity assessment, the recording of information about the duly authorized representative in Ukraine should be performed before the medical products get introduced for circulation within Ukraine’s customs territory. The medical product’s labelling must already contain the Duly authorized representative’s name and location as of the time of the medical products’ customs legalization.   Also, the information about Duly authorized representative gets indicated in the Conformance evaluation certificate. This happens in the context of procedures, which stipulate involvement of the Conformity Assessment Body. That is, the Duly authorized representative  should already be appointed before the conformity assessment procedure ends.

The Duly authorized representative’s obligations are also not affirmed plainly in the statutory instruments. But upon analyzing Ukraine’s legislation and European Union’s regulatory instruments, we may summarize the rights and responsibilities through the agency of hyperlinks, stated below.

“Archimed” company accommodates resources and it has an experience of performing the Duly authorized representative’s duties, which will become a framework for the fulfilment of Ukraine’s regulatory requirements. As for the company itself, it will become a reliable partner for an extended period, working for the client’s benefit and after his standards.

On state market supervision and control of non-food products

p. 6 article 8 Law of Ukraine

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Rights and duties of authorized representative

Duties, Rights of the Duly authorized representative

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The list of documents which should be stored by authorized representative

The bead-roll of documentation for the procedure, set out in the Annex 3 and 8 of theTG (technical guideline), which should be stored by the Duly authorized representative within the territory of Ukraine

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More detailed information can be obtained by writing us a short request or by calling 044 364-81-21.