Technical Regulations on medical devices will come into obligatory effect starting from 1 July 2014 instead of 1 January 2013.
Background: Medical Devices Technical Regulations (hereinafter – Technical Regulations) adopted by the Resolutions of the Cabinet of Ministers of Ukraine No 536 dated 11 June 2008, No 621 dated 9 July 2008, No 641 dated 16 July 2008 (hereinafter – the CMU Resolutions) initially had to come into their obligatory effect since 1 January 2012, but owing to European Business Association’s (hereinafter – EBA) persistent efforts, the date was postponed for the one calendar year – till 1 January 2013, due to urgent necessity of the mentioned documents’ thorough elaboration and adoption of proper medical devices’ standards at the national level.
Over the first half of 2012 the EBA appealed several times to the specialised state authorities regarding the necessity to implement harmonised standards and web-place the Drafts of Technical Regulations at their soonest. In particular, the EBA appeals were sent out to Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health, Oleksiy Solovyov, the Head of the State Service for Medical Drugs, Inna Demchenko, the First Deputy Head of the State Service for Medical Drugs, and Andriy Zaharash, the Deputy Head of the State Service for Medical Drugs. The need was also stressed by the EBA representatives within the framework of a number of meetings with state authorities.
In August and September 2012 the official web-sites of the MOH of Ukraine and the State Service for Medical Drugs (hereinafter – the State Service) eventually saw the Drafts of Technical Regulations (hereinafter – the Drafts). In case of adoption, they could partially harmonise Technical Regulations with the EU Directives and simplify the conformity assessment procedure for the medical devices already registered in Ukraine.
Inter alia, the EBA members were deeply concerned with the absence of harmonised EU standards in Ukraine which are the first-priority conditions for the Technical Regulations to be properly implemented on the whole.
Ukraine for now is still on the way to harmonised standards adoption. Moreover, the discussed amendments to the CMU Resolutions, the official procedure of conformity assessment and its simplified version for the already-registered medical devices weren’t adopted. Thus business community cannot boast adequate conditions f to pass through the procedure and get national conformity mark on their medical devices. Taking into account all the abovesaid the EBA stressed again the real hazard of the prospective stoppage of the medical devices import should the Technical Regulations become obligatory since 1 January 2013.
The appeals where the EBA warned about prospective crisis on the Ukrainian medical devices market, with about 85 % consisting of imported medical devices, and a strong negative impact on patients, were addressed to Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health, Petro Poroshenko, the Minister of Economic Development and Trade of Ukraine, Mykhailo Brodskiy, the Head of the State Committee of Ukraine for Regulatory Policy and Entrepreneurship, and Roman Bogachev, the Deputy Minister of Health of Ukraine.
With the critical situation in mind, the EBA sought for mass media attention to this issue. On 25 December 2012 a press-conference called Problem of January 1st: Would It Be Possible to Deliver Quality Imported Medicines and Medical Devices to Ukrainian Patients? was held, with one of its key issues being the obligatory implementation of Technical Regulations on 1 January 2013.
We are happy to state now that the Joint Order of the MOH of Ukraine No 1498/1126 dated 27 December 2012 “On the adoption of the Amendments to the Certain Orders of the State Committee of Technical Regulation and Consumer Policy and the Ministry of Health of Ukraine” was published. According to the Joint Order the date of the Technical Regulations’ obligatory effect was postponed till July 2014 to adopt all necessary amendments.
The EBA welcomes this step and is looking forward to further cooperation with responsible state authorities when elaborating the CMU Resolutions and other necessary regulatory amendments.