Three Things You Should Know about Medical Device Regulations in Russia and CIS, February 2015

As usual at the end of the month, I would like to share my vision for the main features of a regulatory landscape in the medical device sector in Russia. Here is my selection of highlights for February:

  1. Russia implemented restrictions in the medical device sector

On 6 February 2015, the Russian government implemented restrictions for admission to state tenders for certain types of medical devices. This measure was taken as a part of the initiative supporting the ‘import replacement’ program and ‘promoting the development of domestic manufacturing of medical devices’. According to expert assessments, the share of foreign medical devices in some sectors of Russian state procurements reaches up to 85%. According to the published Decree #102 (link in Russian), which contains a list ‘of certain types of medical devices [45 items] originating from foreign countries subject to restrictions for state and municipal procurements in the Russian Federation’, applications to tender for state and municipal procurements will be denied for foreign manufacturers of medical devices if there are two or more entries from Russia Belarus, Armenia, and Kazakhstan. It should be pointed out that this initiative has been discussed since 2012 and that the restrictions implemented by the decree are relatively softer than those in the previous circulated draft.

  1. Development of Eurasian Medical Device Regulatory Guidelines

The Eurasian Economic Commission is currently developing subordinate acts (second-level guidelines) to implement the strategic agreement on common principles and rules of circulation for medical devices in the Eurasian economic space signed in December 2014. More than ten legal acts addressing medical devices are expected in 2015, but for the moment, only one of them (guidelines to define a safety class for medical and in-vitro devices) has been agreed upon and accepted. The list of Essential Principles of Safety and Performance of Medical Devices (harmonised with GHTF/SG1/N68:2012) and common marking, labelling, and testing requirements are currently under discussion by a working group and may be agreed upon and published in Q2 2015. The common Eurasian medical device registration rules proposed by Kazakhstan and duplicating the existing Kazak medical device approval model is the most active discussion topic among regulators and the medical device industry. Meanwhile, all three regulators (Russian, Belorussian, and Kazak) are consistent in their message that, even though there is a large number of guidelines to accept in a short period, the new system will go into effect in January 2016 and replace current national regulations.

  1. Evolution of Implantable Device Regulations in Russia

1 March is the deadline set by the Russian Ministry of Health to submit proposals for the list of implantable medical devices subject to state reimbursement programmes for 2015. According to the regulator, the list will be reassessed annually, and all proposals submitted after this date could be considered for inclusion in 2016. The current version of the list was published in December 2014 and now contains 205 types of implantable devices grouped based on the recently implemented Russian medical device classification. In parallel, the Russian government set a target date of Q3 2015 to develop and implement a legal mechanism under which medical devices included in the list will undergo price regulation and monitoring to participate in national reimbursement programmes.


The objective of this blog is to make Russian and Eurasian regulations clearer. Please post your comments and questions here or on the Russian medical device regulations Linkedin group.

Russia Implemented Restrictions for Certain Types of Medical Devices for State and Municipal Procurements.

The Russian Government published 06 February 2015 the Order # 102 (link in Russian) with a list “of certain types of medical devices originating from foreign countries subject to restrictions for state and municipal procurements in Russian Federation”. According to this regulation, the tenders for state procurements will be closed for foreign manufacturers if at least two bids with medical devices from local manufacturers (Russia, Kazakhstan or Belarus) were submitted.

The published order will affect the following groups of medical devices:

  • Medical wear.
  • Some types of PCR reagent kits for detection of inflectional agents.
  • Some types of EIA reagent kits for quantitative and qualitative measurement of immunoglobulins and infection agents.
  • Blood clotting reagents.
  • Antiseptic and sterile drapes and wipes.
  • Some types of reagent kits for hematology analyzers.
  • ABO, Rh, Kell systems reagent kits.
  • Enzyme reagent kits.
  • Nutrient mediums.
  • Substrates reagent kits.
  • Polymer specimen containers.
  • Refrigerators for laboratories.
  • Computer tomogram machines 1-64 slices.
  • Gamma chambers.
  • Some types of X-rays diagnostic complexes.
  • ECG machines.
  • Holter ECG monitors.
  • Glucose analyzers.
  • Pneumatic micro motors for dental hand pieces, air-turbine hand pieces.
  • Surgical needles.
  • Some types of disposable syringes.
  • Microsurgical scissors and pincers.
  • Dental carbide burs.
  • Microsurgical ophthalmic instruments.
  • Some types of blood transfusion devices/ containers.
  • Gynecological tool sets.
  • Implants for ostheosyntesis.
  • Non-implantable hearing aids.
  • Blood plasma electrophoresis devices.
  • Blood coagulation analyzers.
  • Bilirubin analyzers and some types of semi-automatic biochemical analyzers.
  • Individual blood glucose meters.
  • Some types of PCR amplificators.