MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

The representatives of the regulatory affairs department of our company took part in a webinar on the registration of medical devices in the EAEU




September 26, 2019

Today on September 26, FGBU "VNIIIMT" Roszdravnadzor" organized a webinar on the topic: "Preparation of documents under the Rules for registration and examination of safety, quality and effectiveness of medical devices (Decision of the EEC Council dated 12.02.2016 No. 46) ". “Carrying out technical tests and biological safety studies for registration in the EAEU (Decisions of the EEC Council of 12.02.2016 No. 28 and of May 16, 2016 No. 38)”, where the representatives of the regulatory affairs department of our company took an active part.

The webinar program included consideration of the registration procedure for medical devices in the territory of the Eurasian Economic Union, as well as the requirements for the necessary documents for registration thereof. In addition, one of the important topics revealed during the seminar were medical devices testing within the EAEU and a plan for post-registration clinical monitoring.

Our representatives prepared a number of questions regarding the registration procedure and requirements for medical devices in the Eurasian Economic Union. The information that was gained from the webinar helped us to fully understand the subtleties of the new procedureю In the nearest time we are going to submit the first application for registration of a medical device in the EAEU.

Mikhailyuk Sorokolat and Partners constantly concerns about the qualification of our specialists so that cooperation with us is useful and effective for our clients.


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