– When it is necessary to appoint an Authorized Representative in Ukraine?
– What are the responsibilities of the Authorized Representative?
– May I appoint a distributor to be as my Authorized Representative?
– How can I preserve confidentiality of the technical documentation for my medical devices?

Do you wish to introduce your medical products to the Ukrainian market? If you are a foreign medical devices manufacturer, and your company doesn’t have a Representative Office in Ukraine, you inevitably and without fail must appoint your Authorized Representative.

According to Ukrainian law, an Authorized Representative is any legal entity or individual entrepreneur – a resident of Ukraine or a representative office of a foreign business entity registered in accordance with the law of Ukraine, which has duly confirmed authority from the manufacturer to fulfil the obligations established by technical regulations.

Your Authorized Representative is the connecting link between you and the National Competent Authorities, as well as consumers.

The Authorized Representative:
– will assist in conformity assessment procedures as required by the law;
– will be your contact person in Ukraine (name, address, contacts are indicated on each product packaging);
– will have in custody the technical documentation for products that, if necessary, shall be provided on request of the Competent Authorities;
– will take the necessary measures in case of receiving reports of incidents with medical devices.

It is possible to appoint your distributor as an Authorized Representative, but this practice is not recommended, as most distributors are not ready to perform the functions of Authorized Representative.

It would be judicious to choose an independent representative who is aware of, first of all, issues of regulatory policy and law in the sphere of medical products circulation, and not sales and marketing.

If you are still reasoning upon the question of who should be appointed as the Authorized Representative – distributor or an independent company – answer the following questions:
– Is your distributor aware of the regulatory policy issues and law in the sphere of medical products circulation?
– Does your distributor monitor legislative changes in the sphere of medical products circulation, so that you can be informed of such changes in time?
– If you have several distributors in Ukraine, will not nomination of one of the distributors as the Authorized Representative be a conflict of interest, as far as name and contact information of the Authorized Representative will be placed on each package of the product?
– Are you sure that the distributor will be able to represent you in relations with the Competent Authorities?
– Do you want to transfer the technical file to your distributor for custody?

Our company has implemented special documented procedures to ensure storage and guarantee confidentiality of the technical documentation entrusted by manufacturers for custody during our performance of the Authorized Representative functions.

Therefore, we preserve the confidentiality of the medical devices technical documentation.

For any questions, please contact our specialists by phone: +38044 360 30 11.