Registration of medical devices in Ukraine, as well as in other countries of the world, implies their legalization and is necessary for the manufacturer to put medical devices on the market.
Since 2015, Ukraine has changed the procedure for state registration of medical devices and introduced a procedure for assessing compliance with the requirements of technical regulations for medical devices, including in vitro diagnostics and active implantable medical devices, as provided for by the Law of Ukraine “On Technical Regulations and Conformity Assessment”.
The most important thing to note right away is that quarantine measures aimed at preventing the spread of COVID-19 have not been canceled in Ukraine, and unfortunately, due to the military aggression (war) of the Russian Federation against Ukraine, the procedure for assessing compliance with the requirements of technical regulations on medical devices with the involvement of the designated body is temporarily carried out remotely. Remote audit of a medical device manufacturer has the following advantages: speed of audit and cost of such audit. The manufacturer of medical devices does not need to pay for the flight of auditors and an interpreter from Ukraine to the country of manufacture of medical devices, pay for hotel accommodation, per diem expenses, etc.
Therefore, the Technical Regulations approved in Ukraine comply with the following European Directives: Council Directive 93/42/EEC concerning medical devices, Directive 98/79/EC on in vitro diagnostic medical devices, Council Directive 90/385/EEC concerning active implantable medical devices.
Accordingly, the registration of medical devices in Ukraine is carried out in accordance with the procedure established by the Technical Regulations, which depends on the type and risk class of the medical device.
1. without involvement of the designated conformity assessment body, by means of the manufacturer’s internal control of compliance with the requirements of the Technical Regulations;
2. with the involvement of the designated conformity assessment body, by assessing the manufacturer’s quality management system.
The first method is the simplest and provides for the completion of internal control by drawing up and signing a declaration of conformity of medical devices with the requirements of technical regulations under the full responsibility of the manufacturer. Based on the results of internal control, the authorized representative retains the documents received from the manufacturer for medical devices – the technical file, developed labels, instructions – not only for the period of sale of medical devices, but also for up to 15 years after the sale of the last product. After executing the declaration and receiving the documents for medical devices, the authorized representative must make an entry in the Register of Persons Responsible for Placing Medical Devices on the Market. From the date of making such an entry, the manufacturer and/or its authorized representative are entitled to import medical devices into Ukraine at a reduced rate of value added tax and sell such devices on the Ukrainian market.
In general, the second method is a more complicated and time-consuming procedure, which is divided into several stages: application to the conformity assessment body with the relevant application form, which must be accompanied by questionnaire forms and lists of medical devices; examination of documents for medical devices – technical file; audit of the manufacturer’s quality management system. Based on the results of the audit, the designated conformity assessment body issues a certificate of conformity. Upon receipt of the certificate of conformity, the manufacturer and/or an authorized representative shall execute and sign a declaration of conformity of medical devices with the requirements of technical regulations under the full responsibility of the manufacturer.
At present, there are all prerequisites for the registration of medical devices in Ukraine to be profitable for the manufacturer, costing several times less and being faster. Therefore, it is time for global manufacturers of medical devices to discover the Ukrainian medical market and take a worthy place in it.
The registration of medical devices in Ukraine, which are urgently needed in all medical areas due to the restoration of critical medical infrastructure, will give a global manufacturer an advantage in developing the Ukrainian medical market.
