Dear Colleagues,

It is the end of the January and I am glad to deliver my monthly update on events in the Russian and Eurasian regulatory landscape.

1. The Eurasian Market for Medical Devices Formally Came into Force

On 1 January 2016, Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan formally introduced a common market and regulatory system for medical devices within the Eurasian Economic Union (EEU). One of the final steps – ratification by Russian parliament – was completed by the end of January. Some (but not all) second-level regulations have now been officially published and are in force: e.g. new rules on post-market safety surveillance can be found on the website of Roszdravnadzor (the Russian medical device regulator).

From a practical standpoint, there is currently no information about how any regulatory step (testing, expertize, clinical trials, registration submission) should be conducted under the new Eurasian approach, and medical device competent authorities in member states continue to receive registration submissions and grant approvals using “old” local procedures. From 1-28 of January 2016, for instance, 166 medical device approvals were registered in the database of the competent authority in Russia, while 87 approvals were made in Kazakhstan and 149 in Belarus.

Roszdravnadzor has announced a full-day regulatory conference (with online broadcast) on 4 February 2016, where more details and guidance about Eurasian medical device integration are expected to be announced.

2. Evolution of Price Regulation for Implantable Medical Devices in Russia

The subjects of price regulation for implantable medical devices and “destabilization of prices in the market” for state procurements have been discussed by Russian government institutions since the end of 2014, when the Russian Ministry of Health published a list of “implantable medical devices approved for state programmes of guarantees on gratuitous medical care”.
In March 2015, Russia adopted amendments to Article #80 of Federal Law No. 323-FZ (“On fundamental healthcare principles in the Russian Federation”) and introduced regulation of maximum sale prices and maximum volume of wholesale and retail mark-ups for medical devices on the previously published list.
On 9 January 2016, the Russian government published Resolution #1517 (link in Russian), titled “On state regulations of prices of medical devices included in the list”. The resolution came into force on 16 January 2016 and set the methodology for how mark-ups on such devices should be calculated. According to the resolution, prices in future state procurement contracts for implantable medical devices on the list cannot exceed the stated values, including after maximum mark-ups and valued added tax have been calculated accordingly.
In addition, the resolution set a deadline of 15 July 2016 for manufacturers or Russian-authorized representatives to submit files to Roszdravnadzor for price registration.

3. Roszdravnadzor on Medical Software

Roszdravnadzor clarified its requirements for medical software. According to the letter released at the beginning of January (link in Russian), the Russian medical device regulator has informed manufacturers that medical software should be considered a type of medical device and must therefore pass the mandatory registration process if it has any of the following uses: operation of medical equipment, receiving diagnostic data, monitoring and transmitting information on bodily functions (including wireless technologies), calculating dosages for medicines or emissions, medical data management, medical image processing, 3D modelling, or connection of medical and diagnostic equipment. Medical software in Russia, like in many jurisdictions, can be registered as a standalone unit or an integrated part of a medical device.

To conclude, I would like to remind that you can follow my updates about Russian medical device regulations on twitter @MedDevRus or get them directly via e-mail using the “Follow” button on the toolbar of this page.

Alexey Stepanov
Alexey@medicaldevicesinrussia.com