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Introduction of mandatory marking using the units of the International System of Units (SI)

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.

Regulatory digest for medical devices in Ukraine

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.

On 27th June, 2018, an external audit of pharmacovigilance processes in Cratia Ltd has been conducted by Ferrer International.

“Cratia Ltd” provides pharmacovigilance processes in Ukraine for variety of national and foreign pharmaceutical companies.

In June 2018, “Ferrer”, an international medical product manufacturer, conducted GVP audit of processes that are being carried out for this company by “Cratia Ltd” in Ukraine.

On July 26, the business forum "Pharma & Cosmo Force" dedicated to issues of health, beauty and FMCG products was held

On July 26, 2018 "Cratia", took part in the business forum "Pharma & Cosmo Force", where illuminated the subject on the regulation in the field of FMCG was developed. Evgenia Andrushchenko, director of business development of the company, presented her report related to the issues of "Regulatory requirements for the circulation of cosmeceutical products". Natalia Kotovskaya, the head of the FMCG department, revealed key aspects of regulatory requirements for nutricosmetics, as well as the next changes in the legislative sphere.

2 - 3 July. The World Congress on Regulatory Affairs for Medical Devices (RAMD2018)

Company Cratia participated in The 2nd World Congress on Regulatory Affairs for Medical Devices - RAMD2018. The Congress took place 2 - 3 July 2018, in London and brought together in one place the best specialists in regulatory services from Israel, USA, Switzerland, Germany, Great Britain, China, the Netherlands and Italy. Cratia also presented its report, which was devoted to regulatory requirements for the circulation of medical devices in the Eurasian Economic Union.

29 March 2018: Our speech on protection from falsified medical devices

Report on protection from falsified medical devices of the 7th Forum of Medical Device Operators, March 29, 2018

The market of medical devices in Ukraine is struggling from falsified products and “grey” import. 

This situation slowly but methodically destroys the business of official representatives and importers, negatively affects the image of manufacturers, creates huge risks to the health of the nation.