Prior to placing medical devices on the market of Ukraine, a non-resident Manufacturer must designate an Authorized Representative in Ukraine, which can be a legal entity or an individual entrepreneur that is a resident of Ukraine.
The Authorized Representative in Ukraine is the link between Ukraine (conformity assessment authorities, market surveillance authorities, revenue and collection authorities, consumers, etc.) and the Manufacturer, ensures the timely communications, and performs post-marketing surveillance.
An Authorized representative – is any legal entity or individual entrepreneur who is a resident of Ukraine or registered in accordance with the legislation of Ukraine, a representative office of a foreign entity, that has duly confirmed the manufacturer’s authority to perform legal actions on it’s behalf regarding the manufacturer’s obligations established by the Technical Regulations.
The Authorized Representative has a lot of other rights and obligations: to keep the technical documentation accessible for competent authorities for at least 5 years (15 years for active implantable devices) from the moment of placing of the last medical device on the market, to participate in inspections of market surveillance authorities and to perform corrective actions on behalf of the Manufacturer, to perform post-marketing surveillance and to notify on incidents, to authorize importers, to blocks “gray” import etc.
Obligations and responsibilities are described in the Technical Regulations for medical devices, the Law “On State Market Supervision and Control of Non-food Products” and other legislative acts. The Order of the Ministry of Health of Ukraine No.142 dated January 22, 2020 approved the national guideline for Authorized representative, based on the European Commission’s Guideline MEDDEV 2.5/10 dated January 2012, but not legally binding.
The designation of an Authorized representative does not change the responsibility of the manufacturer. An Authorized representative must be designated and supervised by the manufacturer.
Each medical device (type/model) should be associated with only one Authorized Representative. The Manufacturer can designate several Authorized Representatives, but for different medical devices.
The Authorized representative’s name and location must be indicated on the labeling of each medical device and/or in the instructions for use (IFU). To improve communication with the consumer, we also recommend to indicate the contact phone number, email and website. The Authorized Representative’s name and address should be also indicated in the Declaration and Certificate of Conformity.
The Authorized representative can be an importer or distributor, or a third organization. Some manufacturers have an internal policy according to which an organization participating in the supply chain cannot be an Authorized representative. Likewise, if the Manufacturer works with several importers (distributors), the designation of any of them as the Authorized representative provides a significant competitive benefit, since its name and address will be indicated on the labeling of all products supplied to Ukraine.
Means of designation
The designation of the Authorized representative is carried out in writing by issuing a Power of Attorney and/or Agreement. The Power of Attorney should be duly certified and legalized.
We recommend to use both documents:
Agreement on the designation of the Authorized representative is not equal to an import/distribution agreement and is usually a separate document, more similar in structure to the operational procedure. In some cases, the Agreement of the designation of the Authorized representative can be amended as an Annex to the import and distribution agreement.
Our lawyer can prepare a draft of the Power of Attorney and/or Agreement for the designation of an Authorized representative in Ukraine, answer the Manufacturer’s questions, explain the requirements for legalization and follow up the signing. We monitor legislation updates and important inquiries of the competent authorities (customs, market surveillance and conformity assessment authorities).
Registration of the Authorized Representative
In some cases, the data on the person responsible for placing the medical devices on the market must be notified (registered) to the competent authority, i.e. the State Service of Ukraine on Medicines and Drugs Control.
Registration is carried out before putting into circulation of the following products:
The procedure for registration is described in the Technical regulations and in the Order No. 122 of the Ministry of Health of Ukraine dated February 10, 2017. The Register is published in electronic form on the website of the State Service of Ukraine on Medicines and Drugs Control.
Duties and responsibilitiesThe duties of the Authorized Representative are described both in the Technical Regulations on medical devices and in related legislative enactments. The list of main responsibilities is as follows:
Fines are established by Article 44 of the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products”:
Fines are imposed for each model, article or batch of the products that are dangerous, pose a risk and/or do not comply with the established requirements, regardless of the number of units of such products and/or places of sale.
Outsourcing of the Authorized representative
If a manufacturer, for some reason, cannot designate it’s importer (distributors) as an Authorized representative in Ukraine or intends to ship products to several distributors – Cratia can be contracted for that role. LLC “Cratia Medtekhnika” is a specialized legal entity performing functions of the Authorized representative to foreign manufacturers. Company is ISO 9001:2017 certified by Bureau Veritas (Italy), has huge experience and a strong team of competent professionals, provides 0-800 toll free telephone etc.
We are not involved in distribution processes that guarantee the absence of conflicts of interest and a highly professional approach. Our liability to third parties is insured under the Voluntary Professional Liability Insurance Agreement.
Dedicated website: https://uarep.com/