Last March 23, 2016 the resolution CMU n. 240 has been officially issued by the Ukrainian Ministry of Health. It states that the current registration certificates shall be replaced with new ones within July 1, 2017 and not later than 5 years from their emission.
The certificates involved in the replacement have the following features:
– issued by the Authority before July 1, 2015;
– not in compliance with the new conformity assessment procedure.
In case of this kind of certificates, it is necessary to procede to register the medical device following the new conformity assessment procedure before July 1, 2017.
For further information: