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Exclusion of certain foreign medical devices from Russian state and municipal procurement

Baker McKenzie

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Russia April 1 2014

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.
www.bakermckenzie.com
For further information please contact
Alexey Trusov +7 495 787 27 00 [email protected]
Sergei Lomakin +7 495 787 27 00 [email protected]
Baker & McKenzie —
CIS, Limited
White Gardens, 10th Floor
9 Lesnaya Street
Moscow 125047, Russia
Tel.: +7 495 787 27 00
Fax: +7 495 787 27 01
BolloevCenter, 2nd Floor
4a Grivtsova Lane
St. Petersburg 190000, Russia
Tel.: +7 812 303 90 00
Fax: +7 812 325 60 13

Content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee similar outcomes. For more information, please visit: www.bakermckenzie.com/en/client-resource-disclaimer.

Baker McKenzie - Alexey Trusov and Sergei Lomakin

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Filed under

  • Russia
  • Healthcare & Life Sciences
  • Projects & Procurement
  • Baker McKenzie

Topics

  • Medical device

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