Good manufacturing practice: overview of the principles and requirements of the DSTU EN ISO 22716 (GMP) standard

26.10.2023

Text is available only in Ukrainian

Other news

13.12.2023

Natal chart of a medical device: how is the MD class determined?

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian

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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 […]

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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 […]

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