15/09 16:00 EBA Health Care Committee Med Devices Subcommittee
Health Care Medical Device Sub-committee met on 15 September 2008 at the EBA office. Among other issues discussed at the meeting, the attendees thoroughly analysed the Draft Law on Medical Devices and further implementation of Technical Regulations. It was stressed that the Subcommittee members as well as Ukrainian manufacturers and the State Service for Medical Drugs and Medical Devices should treat the Draft as a first priority issue. The State Committee of Ukraine for Technical Regulation and Consumer Policy is also interested in having this issue sorted out and the Draft Law approved. Also the Subcommittee members dwelt on the red-tape problem impeding technical regulations implementation. Moreover, structural and institutional changes introduced to the health care sector deteriorated the situation. An agreed plan of technical regulations implementation is still not approved by the State Service of Medical Drugs and Medical Devices. In addition, lack of regulatory procedure affected the progress. Secondly, the participants considered the outcome of the talks with the State Customs Service concerning the database of UKTZED codes and VAT rules. Also the meeting emphasised the reluctance of Customs officers to use the database of registered medical devices, which is regularly updated and submitted to the Custom Serves by the State Service. The Subcommittee members discussed the forthcoming conference on harmonisation and standardisation issues organised by MORION. All the Subcommittee members will be duly informed on possible changes in the next monthly meeting.
General Membership Meeting with local authorities “Small and middle-scale business in crisis situation - EBA Dnipropetrovsk Branch
was held on Thursday, 20.11.2008 at 17:00.
