About three years ago the first Agreement on recognition of conformity assessment results was signed by notified body TÜV SÜD. This agreement started national conformity assessment of medical devices from the European market in a faster, more economical and transparent way.
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:
In this digest you will find the most important news on registration, safety and quality management of medicinal products in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan, which entered into force at the end of 2018 and in the first half of 2019.
The most significant news in brief:
On May 16, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” (hereinafter – “the Law”) was published. The Law will enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions.
On April 9, 2019, the Resolution of the Cabinet of Ministers of Ukraine No. 296 came into force and approved amendments to the Resolution of the Cabinet of Ministers of Ukraine No.
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.
On October 25, 2018, the Procedure for recognition of results of the other countries registration entered into force, approved by Decree of the Cabinet of Ministers of the Republic of Uzbekistan No. 862 dated October 24, 2018 “About approval of the Regulations on procedure for recognition of results of the registration of medicines conducted outside the Republic of Uzbekistan”.
From January 1, 2019, the symbols for use in the labeling of all products put into circulation in the territory of Ukraine, should be indicated in accordance with the Regulations, approved by the Order of the Ministry of Economic Development and Trade No. 914. Specifically, units of measurement should be indicated using those of the International System of Units(SI), for example:
● мг - mg,
● мл - ml,
● Гц - Hz.
We have issued digest regarding regulatory environment for medical devices in Ukraine:
1. Accreditation and designation of three conformity assessment bodies for medical devices has been cancelled in 2018: SE “SMCC”, SE “Cherkasystandartmetrolohiya”, “Politoks” LLC. We have summarised their stories and suggested specific actions for the manufacturer or it’s Authorised representative to be taken towards the conformity assessment certificate issued by mentioned bodies.