Russia Set to Strengthen Price Regulations for Implantable Medical Devices

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Russian President Vladimir Putin signed 09.03.2015 an amendments ( link in Russian )  to the article #80 of the Russian Federal Law #323 “On the Fundamentals of Health Protection in the Russian Federation”. These amendments implements additional regulation for implantable medical devices included in the recently approved list for national reimbursement programmes.

 What is now regulated?

  1. Manufacturer`s maximum sale prices for implantable medical devices.
  2. Maximum wholesale markup for implantable medical devices.
  3. Maximum retail markup for implantable medical devices.

 How it will be regulated?

  1. Methodology for detecting prices and markups will be published by the Government.
  2. State registration procedure for prices and markups will be implemented by Roszdravnadzor (Russian medical device regulator).
  3. Public state registry of prices and markups will be implemented Roszdravnadzor.

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

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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.

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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.

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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.

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

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This is my monthly update with a selection of highlights on medical device regulation changes across Russia and the CIS region.

1. Russia tightens control of medical devices and pharmaceuticals

At the beginning of 2015, Russia implemented amendments to the civil and penal codes and significantly increased penalties on the manufacturing, sale, or trade of counterfeit and unregistered pharmaceuticals and medical devices in accordance with the MEDICRIME European convention signed in 2011. New legislation came into force on 23 January 2015 that enacted stiffer criminal penalties of up to 2,000,000 rubles ($31,000) and a jail term of up to 12 years (for aggravating circumstances) for the manufacturing, sale, or trade of counterfeit pharmaceuticals and medical devices, manufacturing of medical devices without an appropriate license, and forgery of documents accompanying medical devices and pharmaceuticals. The distribution of unregistered medical devices and medical products with characteristics that differ from those declared during registration submission was established as a separate crime as well. In this context, it is to be noted that, according to Mikhail Murashko, head of the Roszdravnadzor (Russian medical device regulator) the number of inspections in the medical device sector will be doubled in 2015.
The text of Federal Law 532 (link in Russian).

2.Russian government is discussing price controls for implantable medical devices.

The Russian Ministry of Health prepared and published a draft (link in Russian) of the regulation, which will introduce a separate procedure for registration and control of maximum sales prices as well as wholesale and retail markups for implantable medical devices on the recently approved list of implantable medical devices subject to state reimbursement programmes. According to the Russian regulator, this measure aims to “solve the problem of destabilization of prices on the market.” Detailed procedures and methods of such controls are not described in the draft, which is open for public discussion until 4 February; nevertheless, the Ministry of Health estimates that this mechanism will come into force at the beginning of 2016 and affect about 10% of the medical devices on the market. Drawing an analogy with Big Pharma, it should be recalled that the Russian implementation of the new law on the circulation of drugs in 2010 resulted in the mandatory registration of prices of drugs listed on the Essential Drug List.

3.Kazakhstan has implemented new safety assessment procedure for medical devices.

The Kazak Ministry of Health published on 21 January 2014 Order #269 on the safety assessment of  registered medicines and medical devices (link in Russian).This regulation defines the list of medical devices (which includes wound and surgical dressings, syringes, hemotransfusion/infusion devices, and some others) that are subject to additional mandatory safety assessment procedures in the country. The described procedure is conducted by the National Centre of Expertise on Medicines and Medical Devices by comparing the safety characteristics of the product with data in the registration dossier submitted previously. The regulation provides a list of required documents and sets a maximum timeline for the procedure of 15 days.
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If you have questions, comments, or ideas on Russian medical device regulations, I encourage you to post them here or to our group.

52% of Resondents Found that Russian Approval Process Became More Difficult.

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More than 52% of respondents of the Medical Device Industry Survey, published by Emergo Group,  consider getting regulatory approval for a medical device in Russia is now MORE DIFFICULT than it was one year ago. According to the Review, China, Russia and Brazil continue to frustrate RA professionals due to long review times, new regulations released and lack of transparancy.

http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey?utm_source=RADAR&utm_medium=newsletter&utm_term=4pm&utm_content=Worldwide&utm_campaign=22Jan2015

Seven Questions on Medical Device Testing for Approval in Russia.

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Russian medical device registration system relies on product testing, and this testing must be completed regardless of whether the device already has FDA, European or other countries` approvals. According to the registration procedure this testing should be done before submission of the registration dossier. The main regulation for medical device testing is The Order #2N by Russian Ministry of Health dated 09.02.2014 (link in Russian). Here I would like to provide the most common questions on this topic:

  1. What tests should be performed for the registration of medical devices in Russia?
     -Before submission all medical devices must pass through technical testing.
    -For active medical devices, testing for electro-magnetic compatibility (EMC) is a mandatory part of technical assessment.
    -If a medical device or it`s accessory has a contact with patient`s body, toxicological testing must be completed.
    – If a medical device is sterile or has a contact with a blood, sterility, pirogenicity and hemocompatibility testing are a mandatory part of toxicological testing.
    – If a medical device is considered to have measuring function, special testing on measurement assessment should be done.
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  2. Who defines which laboratory will perform tests?
    The applicant (manufacturer or its representative) can chose a testing laboratory. Technical, toxicological and EMS testing are usually performed by different centers. The testing laboratory must be accredited by Russian medical device regulator (Roszdravnadzor).
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  3. What should I provide to a laboratory in order to start technical testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Copies of technical reports performed by the manufacturer,
    -Special testing equipment (if applicable in technical file),
    -Information about clinical application of a medical device,
    -Risk management file for a medical device,
    -Technical file and instruction for use,
    –Photo of a medical device,
    -Technical drawings or charts.
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  4. Can technical testing be completed without samples?
    Yes, the technical testing can be completed without providing samples in limited cases: if a medical device is subject to special authorizations or special conditions for installation or/and requires construction of specialized capital facilities. In this case testing can be performed under form of data/document analysis or manufacturing site inspection.
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  5. What exactly is tested in a technical laboratory?
    Technical lab will:
    -Identify a medical device and confirm it`s classification, customs (OKP) code and safety class,
    -confirm that a medical device is compliant with requirements and characteristics described in the technical documentation,
    -Confirm that medical device is compliant with applicable Russian standards e.g. GOST 50444-92 General specifications for Medical instruments, apparatus and equipment, GOST 50267.0.2-2005 General requirements for safety. Electromagnetic compatibility. Requirements and test methods for medical devices , GOST R ISO 14708-1-2012 for implantable medical devices etc.
    -confirm that technical documentation contains full set of characteristics and is compliant with Russian regulations and national standards.
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  6. What should I provide to a laboratory to start toxicological testing?
    Usually the following items are required:
    -Samples of a medical device,
    -Application form,
    -Technical file and instruction for use,
    -Copies of biocompatibility reports performed by the manufacturer,
    -Documents with a detailed description and chemical composition of all materials of a medical device and its accessories,
    -For combination products containing medical drugs, pharmacopeia reference should be provided.
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  7. What exactly is tested in a toxicological laboratory?
    Toxicological laboratory will confirm that a medical device is compliant with national standards e.g. GOST ISO 10993 biocompatibility standards or specific GOST 52770-2007 standard for toxicology testing and will confirm its biological safety.

Do you have other questions on this topic? Post them here!