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Important Changes in Medical Device Regulation
Baker&McKenzie, Kyiv, Ukraine,
Fri, June 17, 2016
Amendments of the Technical Regulations
On 22 March 2016, the Cabinet of Ministers of Ukraine adopted Resolution No. 240 On Amending Certain Resolutions of the Cabinet of Ministers of Ukraine ("Resolution No. 240"), which became effective on 15 April 2016. Resolution No. 240 amended the following technical regulations regarding medical devices: Technical Regulation for Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 753, dated 2 October 2013, Technical Regulation for in vitro Diagnostic Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 754, dated 2 October 2013, and Technical Regulation for Active Implantable Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 755, dated 2 October 2013 (the "Technical Regulations").
Amendments introduced by Resolution No. 240 have improved the regulation of medical devices. The following changes have been made:
• As of April 2016, the Technical Regulations establishing the conformity assessment procedure of medical devices are applicable to medical devices that were registered and permitted for use on Ukrainian territory pursuant to the procedure of medical device registration, which was abolished in June 2015. This change should allow for a smooth transition between the two procedures and ensure that it is possible to conduct conformity assessments of medical devices before their state registration expires.
• The period during which medical devices already introduced to the Ukrainian market may remain in circulation without undergoing a conformity assessment was extended from 1 July 2016 to 1 July 2017. Circulation of such medical devices is limited to up to 5 years from the date of their introduction into circulation on the territory of Ukraine. Prior to the relevant amendments, the circulation of medical devices was limited by their expiration date.
• The provisions of the Technical Regulations concerning maintenance of the Register of persons responsible for introducing medical devices into circulation and appointment of such person by manufacturers, which are non-residents of Ukraine, have been unified. However, the procedure on maintenance of such register, as well as the specific form and timeframe for manufacturers to submit notifications to state authorities has not yet been approved by the regulator.
Maintaining the State Register of Medical Equipment and Medical Devices
On 13 April 2016, the Ministry of Health of Ukraine adopted Order No. 361 On Amending Order of the Ministry of Health of Ukraine dated 16 July 2012 No. 533, which became effective on 3 June 2016. This order amended the procedure for maintaining the State Register of Medical Equipment and Medical Devices. The State Administration of Ukraine on Medical Products was specifically appointed to maintain the State Register of Medical Equipment and Medical Devices. Medical devices which were registered as of 30 June 2015 should remain in the relevant Register until 30 June 2020. Thus, potential obstacles in confirmation of medical device registration during the transition period and subsequent circulation of medical devices for a limited period (up to 5 years from the date of their introduction into circulation on the territory of Ukraine) were eliminated.
Amendments to the Technical Regulations should ensure a smooth transition from the procedure of the state registration of medical devices to the procedure of their conformity assessment. Conducting conformity assessment of medical devices before expiration of their state registration is now specifically allowed. Additionally, transition period during which medical devices already introduced to Ukrainian market may remain in circulation without undergoing a conformity assessment was extended to 1 July 2017. Thus, importers of medical devices can undergo a conformity assessment and mark devices with the national conformity sign before the expiration of the registration of the medical devices.
Additionally, changes to procedure for maintaining of the State Register of Medical Equipment and Medical Devices should enable obtaining confirmation of medical devices registration during the transition period and subsequent circulation of medical devices for a limited period (up to 5 years from the date of their introduction into circulation on the territory of Ukraine).
This LEGAL ALERT is issued to inform Baker & McKenzie clients and other interested parties of legal developments that may affect or otherwise be of interest to them. The comments above do not constitute legal or other advice and should not be regarded as a substitute for specific advice in individual cases.