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News on medical devices in Ukraine, February 2019

1. All medical devices that include radio equipment (Wi-Fi, Bluetooth, GPRS and other radio communication modules) must comply with the Technical Regulations of the radio equipment approved by Decree of Cabinet of Ministers of Ukraine No.355 as of May 24, 2017 and when placing on the market, must be accompanied with relevant Declaration of conformity. The Technical regulation of radio equipment was developed in accordance with Directive 2014/53/EC, however it has a number of national particularities.

We remind you that many medical devices are subject to several Technical regulations and must comply not only with the “profile” medical regulations, but also with other applicable regulations:

  • almost all electronic and electrical medical devices are subject to the Technical Regulations for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (UA RoHS2), approved by Resolution of the Cabinet of Ministers of Ukraine No. 139 of March 10, 2017;
  • many medical devices that perform measurement functions fall within the scope of the Technical Regulations of legally regulated measuring equipment, approved by Decree of Cabinet of Ministers of Ukraine No. 94 of January 13, 2016.

We invite you to participate in a seminar on February 22 (Friday) on three Technical Regulations that can be applied to some groups of medical devices. At the seminar, we will explain on products falling under each of the regulations, conformity assessment routes, special requirements to the national Declaration of conformity and labeling, new responsibilities of importer's, requirements to accompanying documentation etc.

Seminar will be in Russian/Ukrainian language, web streaming is not available this time.

Files for download:

2. Order of Ministry of Economic Development and Trade of Ukraine No.1938 of December 18, 2018 has postponed obligatory implementation of labeling of medical devices and other products with SI units till January 1, 2021. Despite the two-year transition period we recommend to medical device manufacturers to start gradual implementation of national Ukrainian labeling with SI units.

 

3. The State Administration of Ukraine on Medical Products and Control of Narcotics (market supervision authority for medical devices) published the letter No. 327-001.2/005.0/17-19 dated January 14, 2019 regarding notification of business entities about scheduled market inspections of medical devices.

According to this letter, the State Administration informs that planned inspections of product characteristics are carried out only on the basis of a sectoral plan of state market supervision, without a written warning about the inspection.

In this connection, we recommend that manufacturers, their Authorized Representatives and distributors of medical devices pay more attention to the compliance of the labeling and accompanying documentation with the requirements of the Ukrainian legislation.