We inform you on the most actual news regarding medical devices in Ukraine in June, July and August 2019.
Technical regulations and market surveillance. On July 3, amendments to the Law of Ukraine ‘On Technical regulations and conformity assessment’ came in force. Amendments were introduced under the Law ‘On amendments to certain legislative acts of Ukraine on the implementation of acts of European Union legislation in the field of technical regulation’. The most significant changes:
- designated conformity assessment bodies are allowed for the next 2 years (until July 3, 2021) to perform national certifications according to the "old” designations (issued before February 10, 2016);
- clarifications have been made to Article 45 of the Law, which describes the procedure for recognizing the results of conformity assessment conducted outside Ukraine: these results include test reports, documents on conformity and other documents;
- if there is a discrepancy with the requirements for the appointed body, an algorithm of actions has been approved: the regulator applies to the administrative court for measures, including (1) suspension of the certificate in relation to products and/ or procedures, (2) reduction of the scope of destination, (3) cancellation of the certificate of appointment;
- the possibility of affixing a mark of conformity to technical regulations not only on the product itself, but also on any other object specified in the rules and conditions of the marking has been clarified.
Changes set in Law ‘On amendments to certain legislative acts of Ukraine on the implementation of acts of European Union legislation in the field of technical regulation’ have also affected Law of Ukraine ‘on state market surveillance and control of non-food products’, within most important are:
- market surveillance authorities may contact the designated conformity assessment body to provide information not only on issued, suspended, limited documents of conformity, but also information related to conformity assessment procedures to which the conformity assessment bodies were involved;
- the time period by which the designated authorities provide information to market surveillance authorities upon request has been increased: from one business day after receipt of the request by ten days;
- if accompaniment of a product with a declaration of conformity is required by a technical regulation, a copy of a declaration of conformity or a simplified declaration is permitted;
- upon consultation with the market surveillance authority, documents, materials for market surveillance may be provided in a language other than the state language, if this language is understood by officials conducting market surveillance. Otherwise, business entities provide translation of documentation into the state language at their own expense.
Metrological regulation and medical devices. On July 19, Resolution of CMU as for July 10, 2019 №598 was signed, according to which medical devices previously assigned to 13 groups of measuring instruments are excluded from the scope of Technical regulation of legally regulated measuring instruments, approved by Resolution of CMU as for January 13, 2016 №94. The amendments will enter into force on January 19, 2020, six months after the adoption of the decision. This is a long-awaited and important solution that removes the dual regulation of medical devices with the function of control and measurement.
We thanks go to all those who were actively involved in promoting these changes: Association of Market Operators for Medical Devices, American Chamber of Commerce in Ukraine, European Business Association as well as other associations, companies and organizations.
We remind that in addition to “profile” regulations, medical devices may also apply to:
- Regulation for the restriction of the use of certain hazardous substances in electrical and electronic equipment approved by Resolution of the Cabinet of Ministers of Ukraine №139 on 10 March 2017;
- Regulation of radio-equipment, approved by Resolution of the Cabinet of Ministers of Ukraine №355 on 24 May 2017.
Language Law and SI units. On July 16 the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” (hereinafter – “the Law”) came into force, the impact of which on the main aspects of the regulation of medical products was highlighted in our previous newsletter. If for any reason you have not received our letter, please let us know and we will re-send you this information.
We remind that from January 1, 2021 information on the labeling of medical devices should be provided with international SI units taken into consideration. Under these circumstances, the results of measure of medical devices with a measurement function are presented in accordance with SI units according to relevant medical regulations.
Sanitary-epidemiological service conclusions (SES Conclusions). Association of Market Operators for Medical Devices raised the issue of the need to obtain SES conclusions on medical devices. It should be pointed out that earlier the Resolution of the Cabinet of Ministers of Ukraine No.1031 “Some issues of state control of goods moving across the customs border of Ukraine” stipulated that medical devices are not subject to sanitary and epidemiological control.
Resolution of the Cabinet of Ministers of Ukraine No.1031 has ceased to be in force in connection with the adoption of Resolution No. 960 as for November 24, 2018 “Some issues of conducting measures of official control of goods imported into the customs territory of Ukraine”. Medical devices are not included to the scope lists of Resolution No. 960, by the same Article 9 of Law of Ukraine ‘On ensuring sanitary and epidemic welfare of the population’ states following:
Any hazardous factor of a physical, chemical, biological nature that is present in the human environment is subject to hygienic regulation. It is carried out with the aim of limiting the intensity or duration of action of such factors by establishing criteria for their allowable impact on human health’.
Therefore, we recommend obtaining of SES conclusions on medical devices in addition to documents of conformity (certificates and/ or declarations).