Ukrainian Scientific Institute of Certification

Impact of Law of Ukraine ‘On Ensuring the Functioning of the Ukrainian Language as the State Language’ on medical devices’ placing on the market and sales on the territory of Ukraine

17/07/2019

On May 16, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” was published. The Law enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions.

The Law states that the only state (official) language in Ukraine is the Ukrainian language. The main provisions of Law impact on conformity assessment field are considered later in the text.

Analyzing Article 39 of the Law, we assume that information on goods (including, labeling, instruction for use etс.) and services on territory of Ukraine have to be provided in Ukrainian. In cases, if information on goods and services is provided in other languages, content of information on goods and services in state language have to be not less than mandatory content of information according to requirements, set in the Law of Ukraine ‘On customers’ rights protection’. That’s why it is important to keep in mind that all content of information required is specified in other field Laws, regulatory acts and regulatory documents, for example, Technical regulation on medical devices.

Accordingly, the information provided to the consumer on the labeling and in the accompanying documentation on the product, in particular, the instructions for use, must be indicated in Ukrainian.

The use of words, acronyms, abbreviations and symbols in English and/or using Latin and/or Greek alphabets is permitted in information about products (goods), works or services provided in the state language.

By using of this provision we recommend to take awareness of user/customer into consideration and implement it only regarding widely known acronyms/abbreviations.

Special attention has to be given to Article 41 of the Law, which states requirements for use of state language in names of geographical objects and toponymical objects. Particularly, if geographical objects and toponymical objects are located on the territory of other states, when used in Ukraine, shall be provided in the state language in transcription* from the source language taking into account the features of Ukrainian phonetics and spelling. We believe that manufacturer’s address on labeling, instructions and other supporting documents should be provided in Ukrainian. If such geographical object or toponymical object have name of Ukrainian origin, such name can be used instead or along with the foreign language.

Accordingly, the manufacturer’s address on the label and in the accompanying documentation for the product must be indicated in the Ukrainian language. Transition period for this provision is not in place, thus it is mandatory for use since July 16, 2019. We recommend to indicate manufacturer’s name on labeling, instruction for use and other accompanying documentation in origin and Ukrainian language at the same time:

Medical Manufacturer, Berlinstrasse 1, Berlin, Germany

Медікал Меньюфекчурер, Берлінштрассе 1, Берлін, Німеччина

Manufacturer, Coral Street 1, Washington, USA

Меньюфекчурер, вул. Корал 1, Вашингтон, США

* – transliteration – letter by letter introduction of the text (for example: Manufacturing → Мануфактуринг)
– transcription – phonetic introduction of the text: we write down as we hear (manufacturing → меньюфекчуринг)

 

According to Article 42 of the Law Tradenames (marks for goods and services) are indicated in the language in which they are provided with legal protection.

Accordingly, if Tradename is registered in Latin on the territory of Ukraine, it can be indicated on the label and accompanying documentation for device without implementation of transliteration/ transcription rules.

In addition to mentioned, Article 27 states requirements for language of User interfaces of computer programs and those, which are installed on the goods. The Law provides for two categories of user interface for a computer program:

  • Computer program with User interface, that is sold in Ukraine must have interface provided in state and/or English language or other official language of European Union;
  • Computer program with User interface that is installed on goods sold in Ukraine must have interface provided in state language.

Draw your attention that specialized scientific, technical, medical diagnostic equipment other specialized, professional equipment, which is not considered as mass consumer products and its software may not have a user interface in Ukrainian, provided it is available in English.

Accordingly, after the transition period, the user interface in most medical devices, including stand-alone programs, should be in Ukrainian and/ or English.

At the same time, we note that this letter is not a regulatory legal act, it is for informational purposes only and does not establish legal norms.

Regards,

‘Uni-Cert’ LLC team