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

Kazakhstan has introduced a system of accelerated registration of medical equipment

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System accelerated registration of medical equipment introduced in order to improve their state registration procedures, as well as access to health care organizations innovative medical technology. Now, medical equipment, which is certified international expert organizations that have concluded an agreement with the competent authority in the field of health, will rapidly be registered within 5 working days. Earlier this period was 120 days. In the city of Munich (Germany) signed a Memorandum of Understanding between the Ministry of Health and by TUV SUD Product Service GmbH, which provides European quality certificate, which is mandatory for the admission of goods into the European market. The Agreement provides for bilateral cooperation in the field of medical technology through the exchange of experience in assessing the quality of production of medical devices, information in the registration of medical technology and express check in Kazakhstan medical technology with a certificate of TUV SUD Product Service GmbH. With this amendment the Kazakhstan market opens for the world’s top manufacturers of medical equipment.
Source: http://www.mz.gov.kz