Dear colleagues,

Let me share the most important news and updates from the Russian medical device regulatory landscape in March 2016:

1. Detailed Statistics on Medical Device Registration Processes in Russia in 2015

At the beginning of March 2016, Roszdravnadzor (the Russian medical device regulator) published an annual report with detailed statistics on medical device registration procedures in 2015.

According to this document, over the last year, the regulator received and reviewed 1985 registration submissions, among which 1052 (52%) medical devices were approved (447 for Russian manufacturers and 605 for foreign manufacturers). Another 2705 files were submitted for amendment of existing registration certificates (the so-called ВИРУ procedure), with 1853 (68%) receiving approval. The regulator also reported 1307 authorizations for clinical trials of medical devices, 698 administrative renewals of registration certificates, and 1229 authorizations of samples for pre-submission testing in 2015.

Interesting statistics were also provided on submissions of notifications about changes in technical documentation for approved medical devices (a requirement since 2015), with the regulator making 302 approvals and 312 rejections on these submissions over the last year.
A full version of the report (in Russian) is available on the IMEDA website.

2. Possible Extension of the Transition Period for Medical Device Registrations in Ukraine

From today, there are almost three months left until the end of the transitional period set last year by the Ukrainian Government for medical device manufacturers. Currently, for a significant proportion of medical devices available on the Ukrainian market, approval was received before July 2015 via the old registration procedure; current rules allow such medical products to be imported for sale until 1 July 2016, after which they can be used until the documented product service or shelf life expiration date.

However, the Government of Ukraine is now discussing (link in Ukrainian) extending this transitional period to 1 July 2017. This is happening in parallel with another legal initiative (link in Ukrainian) aimed to ensure the national register retains information about medical devices registered before July 2015, with registration information kept until at least June 2020.

It should be recalled that, since July 2015, medical devices in Ukraine can be approved only through new conformity assessment procedures, as evaluated by the relevant Ukrainian notification body (currently, more than ten conformity assessment centres operate in Ukraine).

3. The Russian Ministry of Health is Updating Requirements for Medical Device Technical Files

In recent years, it has become widely accepted that the failure of regulatory bodies to provide full and clear requirements for assessing the technical files of a medical device poses a major challenge within current registration procedures. According to reports from expert organizations, more than 50% of additional requests during the approval process, as well as registration delays, are related to discrepancies or lack of information in the technical documentation of the registration file. Moreover, in practice, current approaches to reviewing technical documentation may differ depending on the organization reviewing the device.

The Russian Ministry of Health is therefore currently developing new regulations in order to establish transparent criteria for evaluating the technical and operational documentation of medical devices, which will simplify the registration procedure. According to the official website, these new requirements are expected to be finalized by June 2016.

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The objective of this blog is to help regulatory professionals better understand the Russian medical device regulatory system. Please post your comments and questions here or in the Russian medical device regulations LinkedIn group.