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:
- 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;
- 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.
- 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:
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.