The Russian Government has for some time been developing draft regulations limiting participation of medical devices that originate from abroad in Russian state/municipal procurement. Prior drafts of such regulations were rather complex and had mechanisms build into them aimed at ensuring that the prohibition is only applicable when Russian analogues of the relevant medical devices exist.
Recently a new draft of the regulations has been published. This new draft establishes that certain medical devices may not be purchased within state/municipal procurement:
if they originate from countries other than Belarus, Kazakhstan and Russia; and
if their manufacturing is not compliant with Russian standard GOST ISO 13485–2011; and
if the price of foreign components used in manufacturing the medical devices exceeds 50% of the price of the medical devices as determined in accordance with the sufficient processing rules established in an international treaty between Belarus, Kazakhstan and Russia; and
if the set of technological documentation, necessary for manufacturing of a medical device does not comply with the Russian Unitary System of Technological Documentation.
This new draft does not have mechanisms build into it aimed at ensuring that the prohibition is only applicable when Russian analogues of the relevant medical devices exist. Very different types of medical devices are listed in the draft regulations, from napkins, certain transfusion systems, syringes and injection needles to stomatology equipment and defibrillators, neonatal intensive care incubators, neonatal warmers, X-ray diagnostic complexes, fluorographs, and computed tomography scanners.
This new draft regulation has not been adopted with the intention of it coming into force on 1 April 2014 in the current version. Russian officials have publicly commented that this draft will be further developed and the aim is to have a final draft ready for official adoption within the calendar quarter (i.e., by the end of June).
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.
For further information please contact
Alexey Trusov +7 495 787 27 00 [email protected]
Sergei Lomakin +7 495 787 27 00 [email protected]
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