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

Other news

12.04.2021

Certification of medical devices during a pandemic. Remote audits, recognition of conformity assessment results, held outside Ukraine

The Ukrainian Scientific Institute of Certification invites you to take part in the 10th anniversary Ukrainian forum of medical device market operators, within the framework of which our specialists will make a report on the topic: “Certification of medical devices during a pandemic: remote audits, recognition of the results of conformity assessment carried out outside […]

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 […]

18.02.2021

On the appointment of UNI-CERT as the conformity assessment body to perform as a third party certain tasks of conformity assessment

By the Orders of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the Ukrainian Scientific Institute of Certification was appointed as a conformity assessment body to perform, as a third party, certain conformity assessment tasks defined in the relevant technical regulation, in accordance with the new requirements of the Law of Ukraine “On […]