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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.

Three Things You Should Know about Medical Device Regulations in Russia and CIS, November 2014

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At the end of this year, one may see a very slow recovery leading into a positive dynamic for Russian regulators of medical devices: the number of registration approvals is increasing and registration steps are gradually becoming shorter. Active work is continuing for the completion of the upcoming harmonization of regulations between Russia, Belarus and Kazakhstan. Below, please find my monthly selection of regulatory highlights for Russia and the CIS region:

1.”Falling Up”

“Medical Device Market: Falling Up” is the slogan of the strategic session chaired by Russian Ministry of Industry and Trade on the 12th of November as a part of the Medica 2014 exhibition in Dusseldorf. More than 100 industry representatives had a chance to get first-hand information about upcoming changes in medical device regulation in Russia directly from top-level officials as well as to discuss strategic scenarios and investment climate for the industry. The focus of this session was on localization and import regulation programs for medical products in Russia. The key strategic message from the regulator remains unchanged – “40% of medical devices for state procurements to be manufactured within Russia till 2020”.
According to Sergey Tsyb, Deputy Ministry of Industry and Trade, “This proposal has been already submitted to the Government of Russian Federation and we hope that it will be signed off within the month. There is special attachment to this document—the list of medical devices, which are already manufactured in Russia. And if there are two or more Russian analogues, this order will allow Russian manufacturers to compete in supplying their products for the Russian healthcare system”.

2. Advertising of Medical Devices across CIS

On the 20th of November, law #203-5 of Kazakhstan (signed in May 2014) came into force, amending Article 18 of National Health Code on the advertising of medical products. According to these changes, advertising medical products (including medical devices and medical equipment) via mass media henceforward is prohibited; rather, such advertisements can be placed only in specialized medical publications or health facilities. Previously, both medical devices and medicines could be advertised only if authorized by the Kazakhstan Ministry of Health according to special procedures; this has been now cancelled per the amendment above.Moreover, it should be noted that similar changes had been rejected in August 2014 by Russian regulators but are currently under intense discussion in Ukraine.

3. Federal Law on Circulation of Medical Devices…Attempt Number Three

The third version of the draft of Federal Law on the Circulation of Medical Devices became available for public discussion in November. Unlike the previous version of the law, which had been proposed by the Ministry of Health and had received controversial feedback from experts, the new version of the regulation was presented by the Ministry of Industry and Trade of Russian Federation. The text of the law has been considerably expanded, especially in the description of the registration process of medical devices. Apparently, the draft will be submitted to the government for approval within weeks, and the law should be enacted by the end of the year. However, work on it is expected to continue through 2015, as it requires harmonization with upcoming changes in regulations concerning medical devices per the Eurasian Customs Union.

Three Things You Should Know about Medical Device Regulations in Russia, October 2014

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October 2014 was remarkable with a series of “big events” on the Russian regulatory landscape which opened up possibilities to get first-hand information from Russian regulatory bodies: a public seminar by Roszdravnadzor on clinical trials, a big conference “Farmmedobrashenie” and a public discussion on “Federal Act on Medical Devices”.

The first interesting statistics on registration of medical devices for this year appeared: the Head of Medical Device registration department announced that there were 1176 positive and 428 negative expertises for registration of medical devices in 2014. It was also stated that after new amendments to registration rules came into force in July, the number of positive outcomes has been rising rapidly, more than tripling, and the quantity of negative outcomes for last two months consisted of 7%.

But…here are the three most important news items I would like to highlight:

  1. Eurasian Economic Union – ratification is completed.
    The Treaty on the Eurasian Economic Union signed by Russia, Kazakhstan and Belarus on 29th May 2014 was ratified by all countries of the Union. Russia officially ratified the document on the 3rd of October, Belarus on the 9th of October and Kazakhstan on the 14th of October. It should be reiterated that the document will come into force on the 1st January 2015 and defines, amongst others, common rules for circulation and registration of medical devices and one registration certificate valid throughout the whole EAU territory from January 2016.  Current “local” registration certificates will be valid within a transition period until 31st December 2021 and will require re-registration according to the new EAU procedure before this deadline.
  1. First edition of the list of implantable medical devices is expected on the 18th of November.
    Strict deadlines (the 6th of October) to submit the dossier for official lists “subject to state reimbursement programmes for implantable medical devices” caused a bustle in the medical device industry at the beginning of the month. Over several days 829 dossiers have been submitted from 72 applicants including manufacturers, distributors, clinical centres and professional associations. The Russian MoH promised to publish the first version of the list after the first Commission session on the 18th of November and also confirmed deadlines for submission for next year`s edition of the list as March 2015.
  1. Federal Law on Medical Devices – the text is available for discussion.
    The text of the draft of the Federal Law on Circulation on Medical Devices became available and became the subject of discussion and critiques on different levels. The current version of the draft describes the powers of federal bodies and stipulates the regulation of medical devices’ circulation throughout their entire life cycle including importation, registration, advertisement, distribution, safety monitoring etc. The draft is available in Russian here.

Three Things You Should Know about Medical Device Regulations in Russia, September 2014

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September saw the introduction of regulatory initiatives which sometimes provoked new questions. Two main aspects of the development of medical device regulations include work on Eurasian medical device guidelines (for which there was no noticeable progress last month) and new legal acts for Russia:

  1. List of implantable medical device reimbursement

Published Order #698, which defines the rules for grouping implantable medical devices in official lists subject to state reimbursement programmes, was the subject of much debate within the Russian medical device industry in September. For future state reimbursement programmes of gratuitous medical treatment system a medical device must be included in this list by a special MoH commission which follows a thirty day procedure. The list should be in line with medical device classification and consist of medical devices registered in Russia based on clinical safety data/justification additionally requested by the commission. The order imposed very strict deadlines for application for inclusion on the current list (as of the 6th of October 2014), but there is not yet a clear list of documents required for submission, the MoH commission still doesn’t exist and the new medical device classifications described in the procedure is far from clear.

  1. New list of medical devices subject to 10% VAT

From the beginning of 2013, new Russian medical device regulations caused confusion over the applicability of VAT for medical device importation. This was largely due to differences in terminology between these guidelines and the Russian tax code. Changes in the Russian tax code in November 2013 made the situation clearer, but the positions of different Russian localities on providing preferential VAT rates for importation remained ambiguous. Government Resolution #870 came into force on the 9th of September 2014, thereby clarifying terminology and confirming the list of medical devices subject to 10% VAT during importation in Russia. Hopefully this will put an end to the lack of clarity for this group of medical products. A government order with a similar list of medical devices subject to 0% VAT is expected within the next few months.

  1. Federal law on circulation of medical devices

The Russian Ministry of Health published a notice about the development of a federal law on circulation of medical devices. The draft of the law is intended to ensure quality, safety and efficacy at every stage of the medical device lifecycle. It is commonly known that this type of unified legal framework is currently missing in Russia, resulting in a number of contradictions between the various regulatory acts in the medical device domain. The MoH announced the target date for this law as January 2016. The text of the current version of the document is currently officially unavailable, and as such it is still unclear how this law will accord with further medical device regulation of Eurasian customs union.

Three Things You Should Know about Medical Device Regulations in Russia, August 2014

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Dear Fellow Colleauges,

At the beginning of my monthly update, I would like to provide some numbers reflecting the activity of the Russian regulator. According to the official Rosdravnadzor site, for the period between 1 and 25 August, 120 registration certificates – both renewals (major part) and new registrations – have been approved, of which 38 approvals for Russian manufacturers. More than 70 unregistered medical devices have been suspended. 102 authorizations for clinical trials and 73 permits for samples importation were issued.

 

  1. New Details on Common Eurasian Medical Device Regulations Emerged:
    Following the fact that the Treaty on the Eurasian Economic Union (EAU) was signed by Russia, Kazakhstan and Belarus on 29 May, the Eurasian Economic Commission (EAEC) published on 11 August the draft of the agreement on common regulations on medical devices for the EAU.
    According to the draft, one registration certificate is anticipated to be valid throughout the whole EAU territory as far as testing performed in one country will be accepted within the Union. The EAEC expects this agreement to come into force on 1 January 2016, and after this date, current (local) registration certificates will be valid until their expiry dates or, if there is no expiry date, until 31 December 2021.
    The draft of the regulations implies a common approach on vigilant data collecting and reporting (a reporting period of five days was set) and labelling (special symbols will be required) for medical devices approved for the EAU.
  2. Coming Regulations on State Procurements of Medical Devices in Russia: “Constraints” Replaced “Strict ban”.
    After the negative feedback from medical and business associations on the draft of the Resolution on “On establishing a ban on individual types of medical devices originating from foreign countries for State and Municipal procurements”, the Russian Ministry of Industry and Trade (Minpromtorg) has officially announced the revision of its position. The term “strict ban” for state procurements for certain groups of medical devices has been replaced with the term “constraints”. The new version of the document assumes that foreign manufacturers will be able to participate in public procurement in the case when fewer than two bids from EAU manufacturers have been submitted for tender. These limitations do not extend to all medical devices, but only to a certain list of products, which has also undergone some changes: some X-ray equipment have been excluded from the list, meanwhile ECG, refrigeration equipment, diagnostic test kits and reagents have been added. It was also highlighted that conformity to the ISO 13485-2011 standard is necessary for EAU manufacturers in order to participate in state and municipal procurements.
  3. New Edition of the Registration Rules in Russia:
    New amendments to the registration rules (Resolution 1416) came into force on 29 July. The most positive outcome is the possibility to eliminate faults during experize phase. Previously there was no such option and any discrepancy in the dossier revealed by the regulator during expertise usually led to an official refusal of registration. On the other hand, some important and broadly-discussed suggestions for improvement, such as fast-track approval for first class medical devices and special procedures to renew expiring registration certificates, have NOT been approved. The new edition of the registration rules slightly extends timelines and reasons for renewals and requires the provision of clinical data in the registration dosser (not before clinical trials as it was previously).

 

Three Things You Should Know about Russian and CIS Medical Device Regulations, July 2014

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The Russian Ministry of Health is quite active, and a lot of initiatives of different level are currently under development: amendments in current registration rule #1416, medical device VAT by-laws, harmonization of Russian medical device nomenclature with GMDN and approval of order of service maintenance of medical equipment. However, in this update, I would like to expand the perspective and highlight the most important regulatory changes in whole CIS region:

 

  1. Russia: New administrative regulation clarifies some “white areas” in current registration rules.
    New administrative regulation #737N regarding the registration of medical devices will come into force within the next days. Since the administrative regulation is legally subordinate to Order #1416, it doesn’t contain any radical changes; instead, it completes the rules and clarifies some existing “white areas” which had not been defined previously:
    – The maximal lead-time for the registration (without clinical trials period) as highlighted in the document is 50 business days;
    -The document defines fees for registration: 6 000RUR for the registration procedure, 1 200 RUR for the renewal, 40 000 RUR for expertize of 1 class medical devices, 2a class – 54 000 RUR, 2b class – 73 000 RUR and 98 000 RUR for expertize of 3 safety class devices;
    – Renewed submission forms for registration and renewal procedures were provided;
    -In addition, document describes the process of obtaining duplicates of the registration certificate in case of damage or loss as well as the procedure of annulations of existing registration;
    – Order of appeal by the applicant in case of non-compliance of approval agency with timelines or registration rules was defined. Appeal pendency time is defined as 15 days;
  2. Ukraine: no changes expected until July 2015.
    Significant reforms were expected this summer in regards to Ukrainian medical device regulations; meanwhile, the political situation in Ukraine remains unstable. Two important legal initiatives were implemented in July: The Ukrainian government introduced a 7% VAT on the import of all medical devices. Moreover, on the 1st of July, 2014, the Ukrainian government extended until July, 2015, the deadline for the implementation of mandatory conformity assessment. From a practical standpoint, this means:
    – The Ukrainian registration certificate remains the main and sole document allowing the import and circulation of medical devices at least until 1 July 2015. A certificate of conformity assessment of technical regulations gives no such permissions.
    -After the 1st of July, 2015, the admission of products already registered in Ukraine is expected to be allowed until the expiry of certificates.
    -After the 1st of July, 2015, access of new products to the Ukrainian market is expected to be possible only through the procedure of assessment of conformity with technical regulations.
  1. Kazakhstan:  Fast-track registration for TUV-certified medical devices.
    The global technical service organization TÜV SÜD and the Kazakhstan MoH signed a Memorandum over future collaborations in the registration of medical devices. In July, the Kazak MoH confirmed that “the system of accelerated registration of medical equipment introduced in order to access to health care organizations innovative medical technology.” Medical equipment certified by international organizations that have concluded an agreement with the Kazak MoH (for the moment, only TÜV SÜD has such an agreement) will undergo an accelerated 5 business day registration procedure. The ordinary registration process in Kazakhstan consists of three steps of expertize which can take up to 180 business days. This initiative is expected to come into force within the next few months. More details on this topic can be found via this link:
    http://www.tuv-sud.com/home-com/resource-centre/publications/e-ssentials-newsletter/mhs-e-ssentials/e-ssentials-june-2014/kazakhstan
    http://www.mz.gov.kz/index.php?option=com_content&view=article&id=1618:kazakhstan-has-introduced-a-system-of-accelerated-registration-of-medical-equipment&catid=16:novosti-ru&Itemid=158&lang=en

Three Things You Should Know about Russian Medical Device Regulations, June 2014

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Taking into account beginning of the summer “low season” for official  organizations, there were no major “sharp” changes in Russian Medical Device Regulations in June but there are still some important strategic points to be aware of:
1. Timelines for the harmonization of medical device market in the Customs Union have been defined. 
The Treaty on the Eurasian Economic Union was signed by Russia, Kazakhstan and Belarus in Astana on 29th May 2014 and will come into force on 1st January 2015.The document is based on the principles of common economic space, which were harmonized by the rules of the World Trade Organization. Articles 31 and 100 of the document suggest the gradual formation of a common market for medical products, with harmonized regulations, standards and unified requirements for the efficiency, safety and quality of medical devices in the entire Customs Union territory. The specific deadline for the beginning of a common market of medical devices was established as 1st January 2016.

2. Russian MoH is working on new medical device classification. 
It is well known that with the implementation of new rules for medical devices in early 2013, the existing classification of medical devices raised a lot of misunderstandings and practical questions. The key message from Roszdravnadzor (the Russian approval agency), transmitted in June 2014, is harmonization of new medical device classification with GMDN (global medical device nomenclature). The new national classification is expected to contain about 22,000 items structured by a 6-digit code built on the GMDN approach. The code is expected to be placed in the registration certificate and be valid throughout all of Russia’s territory. The draft of the new regulations is expected to be available for public discussion in the coming months.

3. Russian medical device industry anticipates amendments to simplify current registration procedure. 
At the end of May 2014, Roszdravnadzor confirmed upcoming amendments of existing procedures for registration of medical devices. The main highlights in the prepared initiative are:
A. “Stopwatch” rule – the possibility to voluntarily suspend the procedure up to 50 days after the first phase of expertize to resolve faults in the dossier or to re-submit additional or missing documents without getting an official refusal.
B. Non-sterile medical devices of first safety class without measurement functions will pass through a simplified registration with a reduced expertize phase.
C. For renewal of expiring registration certificates, a simplified procedure will be implemented instead of a full registration cycle, which is de jure required now according to current rules.