Practical experience of conformity assessment of foreign-made medical devices, 24 February 10.00–18.00
This event has been prepared for representatives and distributors (importers) of foreign-made medical devices, equipment, and in vitro diagnostic devices. During the event, we will talk in detail about the following topics: designation of a manufacturer`s authorised representative in Ukraine, his functions, duties, rights and risks; requ...
Ukrainian Research Institute of Certification has changed location!
Dear colleagues! Ukrainian Research Institute of Certification has changed location, now we are at: 7 Kudryavsky descent, office 320 04053, Kiev, Ukraine Phone / Fax: +38 (044) 338-07-82 +38 (044) 227-41-46 Work schedule: Monday - Thursday from 9.30 to 18.00 Friday from 9.30 to 17.00 without break
Cabinet of Ministers Resolution Extended Transition Period for Technical Regulation on Medical Devices Until 1 July 2017
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 importe...
Notified body representatives took part in the 5th anniversary ukrainian forum of medical device market operators
On 7 April 2016, the Rus Hotel, Kyiv, became the venue for the 5th anniversary Ukrainian forum of medical device market operators The forum highlighted the economic situation and international experience with regard to the medical device market functioning and its specific directions. An interactive focus session with regulators re...
Notified body representatives took part in the “Conformity Assessment A to Z: Import” workshop
On 29-30 March, the workshop titled “Conformity Assessment A to Z: Import” was held at HUB 4.0 conference hall. The participants included representatives from the Association of Medical Device Market Operators, leading experts from the Ministry of Health of Ukraine and the State Administration of Ukraine on Medicinal Products. The workshop h...
Ukrainian Scientific Institute of Certification Accredited as Notified Body
On 4 September 2015, the Ukrainian Scientific Institute of Certification (Uni-CERT) was granted an accreditation certificate by the National Accreditation Agency of Ukraine to carry out the conformity assessment of medical devices and was designated by the Ministry of Economic Development to carry out the assessment of conformity with the Technical...
Changes to Technical regulation on medical devices
On 5 August 2015, Resolution No. 572 of the Cabinet of Ministers of Ukraine amended the Technical regulation on medical devices (Resolution No. 753 of the Cabinet of Ministers). In line with this changes, assistive devices for people and children with disabilities and for other certain populations were excluded from the list of products falling und...