Ukrainian Scientific Institute of Certification
04/04/2016
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...
07/09/2015
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...
06/08/2015
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...