Publications

23.06.2020

Production of sterile medical devices: Clean rooms

Journal “Laboratory” No. 06/2020 The text of the article is available only in Ukrainian

Read more
21.06.2020

Features of the production of sterile medical devices. Clean rooms.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian

Read more
23.01.2020

Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

Read more
10.12.2019

Recognition of EU certificates for medical devices in Ukraine. Simplification, shortening of term and reduction of costs for conformity assessment with the requirements of Technical Regulations.

Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put […]

Read more
28.02.2019

Legalization of import products for the Ukrainian market of medical products

After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory […]

Read more