The 10th anniversary Ukrainian forum of medical device market operators was held

21.05.2021

On May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience.

Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of UNI-CERT LLC, during the session “Technical regulation and conformity assessment of medical devices” made a report on the certification of medical devices during a pandemic, especially drawing the attention of the participants to the most important issues in such a situation, related to remote audits and the recognition of the results of conformity assessment carried out outside of Ukraine.

After the end of the session, a lively discussion took place with the participation of representatives of state, regulatory and supervisory authorities, in which possible practical solutions were discussed to overcome the difficulties of market participants associated with maintaining the validity of certificates during a pandemic and a simplified procedure for introducing medical devices to the Ukrainian market.

Other news

29.10.2021

Basic requirements of DSTU EN ISO 22716:2015 in the production of cosmetic products

The program of the event is available only on Ukrainian or Russian

Read more
01.05.2021

Quality management of medical devices: we apply ISO 13485:2016 without errors

Quality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian

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