Ukrainian Scientific Institute of Certification

Cabinet of Ministers Resolution Extended Transition Period for Technical Regulation on Medical Devices Until 1 July 2017

15/04/2016

On 15 April 2016, Resolution No. 240 of the Cabinet of Ministers of Ukraine of 23 March 2016 on amendments to certain resolutions of the Cabinet of Ministers came into effect.

 

The Resolution allows medical devices that have been registered with the state and entered into the State Register of Medical Equipment and Devices to be imported and placed on the market, without undergoing the conformity assessment procedures and being affixed with the national conformity mark until 1 July 2017 or until their registration expires, whichever comes first.

 

It should be noted that Resolution No. 240 of 23 March 2016 amended and modified the Technical regulations on medical devices.

 

Medical devices may be made available on the market of Ukraine until their expiration date but for not more than five years from the date of their being placed on the market, without undergoing the conformity assessment procedures and being affixed with the national conformity mark.

 

The Resolution also lifted the prohibition to carry out the conformity assessment procedure if there is a valid registration certificate.

 

The full text of the Resolution is available (and can be downloaded) at: http://www.kmu.gov.ua/control/uk/cardnpddocid=248939594